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Key Sessions

Jason Walther PhD

Leveraging ICB at-scale development for accelerated commercial implementation

Sanofi

Thomas Seewoester, PhD

Bioprocessing 4.0 – Digital Technologies Are Transforming Biologics Manufacturing

Amgen, Inc.

Sep 06
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7:15am - 7:45am 30 mins
Info
Workshop
Breakfast Presentation; What's New? High Productivity Harvest and Scalable Pre-packed columns: Debottlecking Bioprocessing
  • Fletcher Malcolm - Director, Product Manager, Repligen
  • John Bonham-Carter - Director, Commercial, Repligen

Two new technologies from Repligen aim at unblocking common bottlenecks in bioprocessing leading to significant improvements in cost and process efficiencies. Learn about the largest pre-packed column available today, the OPUS® 80R, and how it overcomes scalability bottlenecks from bench-scale to commercial-scale downstream purification. Next, learn about High Productivity Harvest, a novel application of XCell™ ATF technology from repligen that overcomes cell retention and productivity bottlenecks, generating 2x more protein while keeping your cell culture in Fed batch mode.

8:00am - 8:10am 10 mins
Keynote Presentations
Chairperson's Opening Remarks
  • Charles Sardonini - Director, Process Engineering/Development, Genzyme
8:10am - 8:55am 45 mins
Keynote Presentations
Leveraging ICB at-scale development for accelerated commercial implementation
  • Jason Walther PhD - Principal Scientist, Downstream Bioprocess Development, Sanofi
8:55am - 9:40am 45 mins
Info
Keynote Presentations
Bioprocessing 4.0 – Digital Technologies Are Transforming Biologics Manufacturing
  • Thomas Seewoester, PhD - Executive Director, Clinical Drug Substance Manufacturing, Amgen, Inc.

Manufacturing processes for biologics have been optimized for the last 100 years. Revolutionary steps in the last 20 years included the introduction of process platforms for monoclonal antibodies, the perfection of large scale fed-batch processes and recently more economic scale-out approaches in single-use systems. Digital technologies in contrast are following a much more rapid and exponential innovation curve. Understanding and leveraging digital technologies, looking beyond the molecule and refining mountains of data into instantaneously and globally available insights and wisdom will be a differentiating factor that is starting to transform our industry in the same way as it has other industries.

9:00am - 10:25am 85 mins
Info
2-Day Training Course: Introduction to BioPharmaceutical Manufacturing
Introduction to BioPharmaceutical Manufacturing*
  • James Dean Vogel - Founder and Director , The BioProcess Institute

Sept 5-6 from 9am-5pm


A comprehensive two-day workshop course on the basic principles and applications used in the production of BioPharmaceutical Products. The course is designed to provide an overview of the technology and parameters affecting process performance and scale-up. Application modules have been designed to demonstrate state-of-art processes. Lectures are integrated into the workshop to stress the scientific and business principles. Specific examples, such as aseptic technique, sterilization, cell growth, product filtration, and product chromatography, are presented to illustrate the problems and solutions encountered in BioPharmaceutical Manufacturing processes.

Attendees range from technically trained employees from other industries who are new to the BioPharmaceutical Industry or want to gain a better understanding of the industry’s technology and Non-Technical employees of the BioPharmaceutical Industry. It will to provide them with a better understanding of the complex Technology to produce a BioPharmaceutical Drug product.

  • Schedule:
  • BioPharmaceutical/Pharmaceutical Industry overview and current trends
  • BioPharmaceutical Process Overview
  • Manufacturing Processes

    • Cell Growth
    • Purification
  • Filtration
  • Chromatography

    • Fill Finish/Drug Product
  • Facility and Support Processes
  • Bioburden and Environmental Risks and Methods for Environmental Control
  • Cleaning, Sanitization and Sterilization
  • cGMP and Regulations

*Separate registration fee required

9:40am - 10:25am 45 mins
Keynote Presentations
Networking Refreshment Break in Poster & Exhibit Hall
9:50am - 10:00am 10 mins
Innovation Live Presentations
Theater Showcase
10:00am - 10:10am 10 mins
Info
Innovation Live Presentations
New AseptiQuik® Connector For Higher Flow in Bioprocessing
  • Todd Andrews - Global Sales and Business Development Manager, Bioprocessing, CPC - Colder Products Company
10:10am - 10:20am 10 mins
Info
Innovation Live Presentations
The next Generation of Single-use BioProcessing Automation
  • Frank Meyeroltmanns - Global Marketing Manager, Purification Technologies, Sartorius Stedim Biotech GmbH
10:25am - 10:30am 5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
  • Charles Sardonini - Director, Process Engineering/Development, Genzyme
10:25am - 10:30am 5 mins
Speed from Gene to Market
Chairperson's Remarks
  • Pranhitha Reddy, Ph.D. - Founder, Gene to BLA Consulting
10:25am - 10:30am 5 mins
Recovery & Purification
Chairperson's Remarks
  • Charles Sardonini - Director, Process Engineering/Development, Genzyme
10:25am - 10:30am 5 mins
Manufacturing Strategy
Chairperson's Remarks
  • Pranhitha Reddy, Ph.D. - Founder, Gene to BLA Consulting
10:25am - 10:30am 5 mins
Drug Product, Fill-Finish & Formulations
Chairperson's Remarks
  • Dingjiang Liu, PhD - Director, Formulation Development, Regeneron Pharmaceuticals
10:25am - 10:30am 5 mins
Analytical & Quality
Chairperson's Remarks
  • Charles Sardonini - Director, Process Engineering/Development, Genzyme
10:25am - 10:30am 5 mins
Info
Technology Innovation Forum with Round Robin Technology Showcase
Moderator’s Welcome and Introduction
  • Lynne Frick - Founder, Bioguides

Join an interactive session of senior industry professionals, all members of the Boston based BioInnovation Group, who volunteer their time to actively seek out and identify emerging technologies, or technologies in other industries, that could have a significant impact in Life Sciences. Their mission is to advance these new and emerging technologies and biotools by providing expert opinions, ideas on applications and in some cases, development advice to improve the chances of success and ultimate adoption of new technologies into the industry. There will be a short introductory session followed by the opportunity to explore six emerging new technologies in small interactive round tables as participants rotate through ‘tables’ of their choosing staffed by members of the BioInnovation group and the entrepreneurs/developers of these new technologies. 

10:25am - 12:00pm 95 mins
Info
2-Day Training Course: Introduction to BioPharmaceutical Manufacturing
Introduction to BioPharmaceutical Manufacturing*
  • James Dean Vogel - Founder and Director , The BioProcess Institute

Sept 5-6 from 9am-5pm


A comprehensive two-day workshop course on the basic principles and applications used in the production of BioPharmaceutical Products. The course is designed to provide an overview of the technology and parameters affecting process performance and scale-up. Application modules have been designed to demonstrate state-of-art processes. Lectures are integrated into the workshop to stress the scientific and business principles. Specific examples, such as aseptic technique, sterilization, cell growth, product filtration, and product chromatography, are presented to illustrate the problems and solutions encountered in BioPharmaceutical Manufacturing processes.

Attendees range from technically trained employees from other industries who are new to the BioPharmaceutical Industry or want to gain a better understanding of the industry’s technology and Non-Technical employees of the BioPharmaceutical Industry. It will to provide them with a better understanding of the complex Technology to produce a BioPharmaceutical Drug product.

  • Schedule:
  • BioPharmaceutical/Pharmaceutical Industry overview and current trends
  • BioPharmaceutical Process Overview
  • Manufacturing Processes

    • Cell Growth
    • Purification
  • Filtration
  • Chromatography

    • Fill Finish/Drug Product
  • Facility and Support Processes
  • Bioburden and Environmental Risks and Methods for Environmental Control
  • Cleaning, Sanitization and Sterilization
  • cGMP and Regulations

*Separate registration fee required

10:30am - 11:00am 30 mins
Cell Culture & Upstream Processing
Implementing Continuous Processing in Manufacturing
  • Sanchayita Ghose, Ph.D. - Director, Downstream Process Development, Biologics Process Development, Bristol-Myers Squibb Company
10:30am - 11:00am 30 mins
Speed from Gene to Market
Screening/Scale Models for Accelerating Process Development Cycle Times
  • Hang Yuan, PhD - Head of Global Upstream Process Development, Shire
10:30am - 11:00am 30 mins
Recovery & Purification
Implementing Continuous Processing in Manufacturing
  • Sanchayita Ghose, Ph.D. - Director, Downstream Process Development, Biologics Process Development, Bristol-Myers Squibb Company
10:30am - 11:00am 30 mins
Manufacturing Strategy
Screening/Scale Models for Accelerating Process Development Cycle Times
  • Hang Yuan, PhD - Head of Global Upstream Process Development, Shire
10:30am - 10:50am 20 mins
Info
Drug Product, Fill-Finish & Formulations
An Inter-Company Perspective on Biopharmaceutical Drug Product Robustness Studies
  • Dingjiang Liu, PhD - Director, Formulation Development, Regeneron Pharmaceuticals

Drug Product (DP) robustness studies ensure a product meets quality standards when formulation and process parameters are within established ranges. The BioPhorum Development Group (BPDG) authored a commentary on DP robustness (S. Morar-Mitrica, et al, J.Pharm.Sci. (2018), 107: 529-542) focused on the current scope, design and execution of biopharmaceutical DP robustness studies. Common themes were identified with regard to the use of DP robustness studies, with integrated case studies.

10:30am - 11:00am 30 mins
Analytical & Quality
Implementing Continuous Processing in Manufacturing
  • Sanchayita Ghose, Ph.D. - Director, Downstream Process Development, Biologics Process Development, Bristol-Myers Squibb Company
10:30am - 10:50am 20 mins
Info
Technology Innovation Forum with Round Robin Technology Showcase
Panel Discussion: The Importance of Supporting Technology Innovation
  • Thomas Seewoester, PhD - Executive Director, Clinical Drug Substance Manufacturing, Amgen, Inc.
  • Jorg Thommes, PhD - Head of CMC, Bill & Melinda Gates Medical Research Institute
  • Michael Laska, PhD - Vice President, CMC Development and Manufacturing, Casebia Therapeutics
  • Derek Adams, PhD - Chief Technology and Manufacturing Officer, Bluebird Bio
  • Neal Gordon, PhD - Chief Development Officer, Cobalt Biomedicine

Panelists:

Thomas Seewoester, Ph.D., Executive Director, Plant Manager, Amgen

Michael Laska, Ph.D., Vice President, CMC Development and Manufacturing, Casebia Therapeutics

Derek Adams, Chief Technology and Manufacturing Officer, Bluebird Bio

Neal Gordon, Chief Development Officer, Cobalt Biomedicine

Jorg Thommes, Ph.D., Head of CMC, Bill & Melinda Gates Medical Research Institute

10:50am - 11:15am 25 mins
Info
Drug Product, Fill-Finish & Formulations
Progress and Challenges in Automation-Assisted Formulation Development at Genentech
  • Jia Sun - Engineer, Genentech

As protein therapeutics become more structurally diverse and the development timeline gets more compressed, the need to evaluate a wider range of formulation conditions increases. One consideration is using high-throughput technology for formulation selections, and this technology has been successfully employed in many other pharmaceutical process development areas such as cell culture and protein purification. In spite of this, there has been limited implementation of this technology in the formulation development process. Our group has recently evaluated two formulation development processes where high-throughput technology can benefit. We developed a new automation-assisted formulation preparation method for large screens such as DOE type of studies. This method allows us to rapidly prepare a large number of formulations with up to 95% less raw material (buffer). To further streamline and reduce the manual operations involved in the formulation development process, we searched for miniaturized containers for conducting protein stability studies. We evaluated different types of glass and plastic vials with the standard 2CC glass vials. However, there is a significant difference between the standard 2CC glass vial and other glass and plastic vials in terms of protein oxidation under thermal stressed condition. Overall, there are both opportunities and challenges for using high-throughput technology in the area of protein formulation development.

10:50am - 12:00pm 70 mins
Info
Technology Innovation Forum with Round Robin Technology Showcase
Technology Round Robin Featuring 6 Innovative Bioprocess Technologies
  • Lynne Frick - Founder, Bioguides
  • Natraj Ram, PhD - Associate Director, Abbott Bioresearch Center
  • Tom Ransohoff - Vice President & Senior Consultant, Bioprocess Technology Consultants
  • Roger Nassar, PhD - Founder and CEO, RAN Biotechnologies
  • Carl Beckett - Vice President of Business Development, Covaris
  • Sean Kevkahan, PhD - CEO, Quad Technologies
  • Chase Coffman, PhD - Co-Founder, Elektrofi
  • Rachel Dorin, PhD - Founder and CEO, TeraPore Technologies
  • Marty Siwak - Chief Commercial Officer, TeraPore Technologies
  • Michael Laska, PhD - Vice President, CMC Development and Manufacturing, Casebia Therapeutics
  • Cheryl Huie - Business Development Consultant, Axiom Collaborative
  • Neal Gordon, PhD - Chief Development Officer, Cobalt Biomedicine
  • David Fritsch - Senior Director, Strategic Programs, Project Management Office and Operational Excellence, Sanofi Genzyme

Six exciting technologies with bioprocess applications will be presented at six roundtables in 10-12 minute rotations. Each round table will be staffed by the technology presenter and a member of the Bioinnovation Group who will act as a Q&A/discussion facilitator. Each 10-12 minute rotation will consist of a 3-4 minute “elevator”/”shark-tank”-like pitch about the technology followed by a moderated Q&A. Attendees will rotate through all 6 roundtables during this session.


Table 1: RAN Biotechnologies

Technology: Nano-material based “Point of Use” Bioburden test using a hand-held device

Technology Presenter: Roger Nassar, Ph.D., Founder and CEO, RAN Biotechnologies

Table Moderator/Bioinnovation Group Member: Michael Laska, Ph.D., Vice President, CMC Development and Manufacturing, Casebia Therapeutics

Significance claim or application(s):

• May be used as a yes/no quick test for live microbes & spore formers
• Can be used in flow environment

Table 2: Covaris

Technology: Adaptive Focused Acoustics employs highly controlled bursts of focused high-frequency acoustic energy in a temperature-controlled and non-contact environment

Technology Presenter: Carl Beckett, Vice President, Covaris

Table Moderator/Bioinnovation Group Member: Cheryl Huie, Business Development Consultant, Axiom Collaborative

Significance claim or application(s):

• Many new applications in Bioprocess (beyond web site)

• Filterless, non-contact cell retention/depletion

• Inclusion body & difficult protein extraction

• Improve transfection/transduction efficiencies

• Single cell suspensions, acoustical mixing in a scalable format

Table 3: Quad Technologies

Technology: Novel dissolvable hydrogel, Quickgel, which enables users to capture and release cells from various substrates

Technology Presenter: Sean Kevkahan, CEO, Quad Technologies

Table Moderator/Bioinnovation Group Member: Neal Gordon, Chief Development Officer, Cobalt Biomedicine

Significance claim or application(s):

• Used as label free cell separation
• Cell therapy manufacturing

Table 4: TeraPore Technologies

Technology:  Novel membrane technology – high resolutions, nano filtration

Technology Presenters: Rachel Dorin, Ph.D., Founder and CEO, TeraPore Technologies

Marty Siwak, Chief Commercial Officer, TeraPore Technologies

Table Moderator/Bioinnovation Group Member: David Fritsch, Senior Director, Strategic Programs, Project Management Office and Operational Excellence, Sanofi Genzyme

Significance claim or application(s):

• Virus filtration

Table 5: Elektrofi

Technology: Generate Elecktrojet particles, suspend biologics in GRAS liquid

Technology Presenter: Chase Coffman, Co-Founder, Elektrofi

Table Moderator/Bioinnovation Group Member: Natraj Ram, Ph.D., Associate Director, Purification, Manufacturing Sciences, AbbVie

Significance claim or application(s):

• Makes 500mg/ml formulations possible as Sub Q without viscosity issues

Table 6: 4th Dimension Bioprocess

Technology: Continuous Bioprocessing / data analytics consortium

Technology Presenter: Lynne Frick, Founder, Bioguides

Table Moderator/Bioinnovation Group Member: Tom Ransohoff, Vice President & Principal Consultant, Bioprocess Technology Consultants

Significance claim or application(s):

• Fully integrated DSP

11:00am - 11:30am 30 mins
Cell Culture & Upstream Processing
Effect of Cell Culture Process Change from Fed-batch to Continuous on Productivity and Product Quality
  • Ru Zang - Director, Momenta Pharmaceuticals
11:00am - 11:30am 30 mins
Info
Speed from Gene to Market
Experiences and Challenges during the Commercialization of a Monoclonal Antibody
  • Jeffrey Ly - Associate Principal Scientist, Merck

A variety of scientific and regulatory challenges may be encountered during the commercialization of a monoclonal antibody. In this work, we present case studies detailing a series of experiences and lessons learned during this process. The work will cover topics including qualification of scale-down models, troubleshooting scale-up and tech transfer, mitigation strategies for process performance variability, and confirmation of clonality. A variety of experimental and statistical methodologies were implemented to address these concerns, including application of multivariate data analysis. Details of the methodologies will also be provided to demonstrate their application to troubleshooting of commercial upstream fed-batch production processes.

11:00am - 11:30am 30 mins
Recovery & Purification
Effect of Cell Culture Process Change from Fed-batch to Continuous on Productivity and Product Quality
  • Ru Zang - Director, Momenta Pharmaceuticals
11:00am - 11:30am 30 mins
Info
Manufacturing Strategy
Experiences and Challenges during the Commercialization of a Monoclonal Antibody
  • Jeffrey Ly - Associate Principal Scientist, Merck

A variety of scientific and regulatory challenges may be encountered during the commercialization of a monoclonal antibody. In this work, we present case studies detailing a series of experiences and lessons learned during this process. The work will cover topics including qualification of scale-down models, troubleshooting scale-up and tech transfer, mitigation strategies for process performance variability, and confirmation of clonality. A variety of experimental and statistical methodologies were implemented to address these concerns, including application of multivariate data analysis. Details of the methodologies will also be provided to demonstrate their application to troubleshooting of commercial upstream fed-batch production processes.

11:00am - 11:30am 30 mins
Analytical & Quality
Effect of Cell Culture Process Change from Fed-batch to Continuous on Productivity and Product Quality
  • Ru Zang - Director, Momenta Pharmaceuticals
11:15am - 11:40am 25 mins
Info
Drug Product, Fill-Finish & Formulations
Application of Submicron Particle Tracking Technique in Characterizing Aggregation and Particle Formation during Product Development
  • Stanley Kwok, PhD - Scientist, Seattle Genetics

Aggregate/subvisible particles are critical quality attributes that are carefully studied during drug development due to their possible linkage to immunogenicity. Here we present the implementation of submicron particle tracking technology during antibody drug conjugates (ADCs) development. The submicron particle tracking flow microscopy method provides a quantitative profile of subvisible particulates in the 50-1000nm range (mAbs and ADCs). The obtained particle distribution/count data from different stressed studies provide potential mechanistic insight of aggregate behavior in the submicron characterization gap.

11:30am - 12:00pm 30 mins
Cell Culture & Upstream Processing
Full-Line Integrated Continuous Process from Upstream to Downstream
  • Karen Wen, PhD - President, Mycenax Biotech Inc.
11:30am - 12:00pm 30 mins
Speed from Gene to Market
PANEL DISCUSSION: Balancing Speed and Risk in Manufacturing
  • Pranhitha Reddy, Ph.D. - Founder, Gene to BLA Consulting
  • Mark Yang, PhD - Director, Global Pharmaceutical Development Biologics, Sanofi
  • Li Zang, PhD - Associate Director, Analytical Development, Biogen
  • Sigma Mostafa, PhD - Vice President, Upstream & Downstream Process Development, KBI Biopharma
  • Sourav Kundu, PhD - Senior Director, Teva Pharmaceuticals
11:30am - 12:00pm 30 mins
Recovery & Purification
Full-Line Integrated Continuous Process from Upstream to Downstream
  • Karen Wen, PhD - President, Mycenax Biotech Inc.
11:30am - 12:00pm 30 mins
Manufacturing Strategy
PANEL DISCUSSION: Balancing Speed and Risk in Manufacturing
  • Pranhitha Reddy, Ph.D. - Founder, Gene to BLA Consulting
  • Mark Yang, PhD - Director, Global Pharmaceutical Development Biologics, Sanofi
  • Li Zang, PhD - Associate Director, Analytical Development, Biogen
  • Sigma Mostafa, PhD - Vice President, Upstream & Downstream Process Development, KBI Biopharma
  • Sourav Kundu, PhD - Senior Director, Teva Pharmaceuticals
11:30am - 12:00pm 30 mins
Analytical & Quality
Full-Line Integrated Continuous Process from Upstream to Downstream
  • Karen Wen, PhD - President, Mycenax Biotech Inc.
11:40am - 12:00pm 20 mins
Drug Product, Fill-Finish & Formulations
Potential Impact of Nano Particulate Impurities from Sugars on Therapeutic Proteins
  • Anant Sharma - Formulation Scientist, Eli Lilly & Co.
12:05pm - 12:35pm 30 mins
Info
Workshop
High Throughput Data Driven Process Development
  • Kevin McHugh - ambr Taskforce Leader, Sartorius Stedim Biotech
  • Frank Meyeroltmanns - Global Marketing Manager, Purification Technologies, Sartorius Stedim Biotech GmbH

Part 1:

Development of ‘ambr 250 perfusion’ – A Novel Automated Single-Use Perfusion Mini-Bioreactor 

Speaker: Kevin McHugh -- Sartorius Stedim North America Inc.

Details:
In recent years a strong trend towards continuous processing has gathered momentum, driven by the promise of process intensification, reduced cost of goods, and more consistent and better controlled product quality. Benchtop bioreactors provide a route to developing this new wave of intensified/continuous cell culture processes. However this approach is manually intensive, relatively low throughput and cost-intensive to operate. The ambr bioreactor systems have been widely implemented as a high-throughput approach to screening and process development of fed-batch cultures. The ambr product line is expanding to include ambr 250 perfusion, which enables up to 24 single-use perfusion cultures to be carried out simultaneously under fully automated control. The ambr 250p reduces the complexity and expense associated with medium to large scale perfusion culture systems and makes optimization experiments involving DOE approaches more straightforward to complete. This workshop will highlight the key features of this novel system and showcase case studies that show system robustness and capability of reaching culture densities greater than 100 million cells/mL. Lastly, data will be presented showing the capability of this system to be used for both traditional perfusion processes as well as intensified fed-batch cultures.

 

Part 2:

Gain manufacturability information for downstream processing already during your candidate selection

Speaker: Frank Meyeroltmanns,  Marketing Manager, Purification technologies,  Sartorius Stedim GmbH, Germany

Details:
Manufacturability becomes more important in recent years as streamlining the process development is the only area where time to market can be optimized.Challenges like e.g. tendency to aggregate etc. of the selected candidate during the development of the downstream process can be time consuming especially during scale-up to secure a highly productive commercial manufacturing process.The ability to study some of this properties during the candidate selection will make the process development more predictive. ambr crossflow is a screening tool developed exactly for this purpose combined with early stage characterization and optimization. Minimal volume requirements provide the base to study the behavior of your candidate in multi-parallel experiments. Identifying the behavior under stress conditions like cross flow operations, different buffer condition, high concentrations and formulation will support decisions in the downstream development. In this technical presentation the working principles of the multi-parallel system and examples from real product condition will be presented.

12:05pm - 12:35pm 30 mins
Info
Workshop 2
Multiple approaches for process intensification
  • Nigel Darby - Advisor, GE Healthcare

How can process intensification help you manufacture biopharmaceuticals quicker and at lower cost? Let us count the ways.

There are many options for improving bioprocess productivity. These vary depending on the unit operations in your processing train. Here we will discuss possibilities across upstream and downstream. First, we will pinpoint factors to help you design a productive perfusion process. Media development, cell line productivity, and bioreactor design will be emphasized. Next, we will describe the process intensification toolbox for downstream processing. Choices include continuous mAb capture, new high-productivity chromatography resins, and capture on novel fiber-based chromatography devices. Other tools are in-line buffer conditioning and straight-through processing. Last, we will address end-to-end options that increase automation level, including ‘off-the-shelf’ factories. We hope you leave this talk with ideas for improving your biomanufacturing processes.

12:05pm - 12:35pm 30 mins
Info
Workshop 3
Screening and Characterization of Clones in Days instead of Months
  • Anupam Singhal, PhD - Sr. Manager, Technology Development, Berkeley Lights, Inc.
12:05pm - 12:35pm 30 mins
Info
Workshop 4
Custom Media Development to Maximize Your Cells’ Potential
  • Thomas Fletcher - Scientific Director, Irvine Scientific

The production of therapeutic biologics requires high titers and excellent product quality to ensure efficient manufacturing and potent drug efficacy. Irvine Scientific is capable of maximizing a cell line’s potential and improving antibody product quality through our custom Media Development and Optimization program. Media development begins with a Media Survey Panel to improve cell growth and titer and then focuses on improving product quality through our analytics and optimization processes. The N-glycan profile is a critical quality aspect that can alter antibody binding and function.

12:05pm - 12:35pm 30 mins
Info
Workshop 5
CELL & GENE THERAPIES: Jumpstart Cell & Gene Therapy Commercialization With SUT Learning
  • Derek Pendlebury, Ph.D. - OEM Channel Manager, Bioproccessing, CPC - Colder Products Company

FDA approvals of cell and gene therapies (CGTs) are cause for celebration — but the marathon isn’t done. Attention turns to commercial-scale manufacturing challenges of these therapies. Many current CGT manufacturing processes used for clinical trials are inadequate for commercialization. This presentation captures learnings about using single-use technologies in biopharmaceutical manufacturing that can be applied to CGTs, focusing on connection technologies.

12:05pm - 12:35pm 30 mins
Info
Workshop 6
Extractables Testing Update
  • Donald Young - Senior Global Product Manager, Thermo Fisher Scientific

The choice of materials used to produce flexible plastic BioProcess Containers (BPCs) shape their mechanical, physical, chemical, and biological characteristics and is one of the most important decisions to be made when choosing single-use technology (SUT) products and suppliers. This presentation details the importance of the extractables profiles of the plastic films and includes Thermo Fisher Scientific’s extractables testing strategy.

12:05pm - 12:35pm 30 mins
Info
2-Day Training Course: Introduction to BioPharmaceutical Manufacturing
Introduction to BioPharmaceutical Manufacturing*
  • James Dean Vogel - Founder and Director , The BioProcess Institute

Sept 5-6 from 9am-5pm


A comprehensive two-day workshop course on the basic principles and applications used in the production of BioPharmaceutical Products. The course is designed to provide an overview of the technology and parameters affecting process performance and scale-up. Application modules have been designed to demonstrate state-of-art processes. Lectures are integrated into the workshop to stress the scientific and business principles. Specific examples, such as aseptic technique, sterilization, cell growth, product filtration, and product chromatography, are presented to illustrate the problems and solutions encountered in BioPharmaceutical Manufacturing processes.

Attendees range from technically trained employees from other industries who are new to the BioPharmaceutical Industry or want to gain a better understanding of the industry’s technology and Non-Technical employees of the BioPharmaceutical Industry. It will to provide them with a better understanding of the complex Technology to produce a BioPharmaceutical Drug product.

  • Schedule:
  • BioPharmaceutical/Pharmaceutical Industry overview and current trends
  • BioPharmaceutical Process Overview
  • Manufacturing Processes

    • Cell Growth
    • Purification
  • Filtration
  • Chromatography

    • Fill Finish/Drug Product
  • Facility and Support Processes
  • Bioburden and Environmental Risks and Methods for Environmental Control
  • Cleaning, Sanitization and Sterilization
  • cGMP and Regulations

*Separate registration fee required

12:35pm - 1:40pm 65 mins
Main Conference
Networking Luncheon & Networking in Exhibit Hall
12:40pm - 1:00pm 20 mins
Info
Innovation Live Presentations
Addressing complexity in bioscience processes with Antha: cloud based automation software
  • Markus Gershater - Chief Scientific Officer, Synthace
1:00pm - 1:10pm 10 mins
Info
Innovation Live Presentations
Advanced Multi-Column, Multi-Function Chromatography Platform
  • Gerard Gach, BS - Chief Marketing Officer, LEW Bioprocess Group
1:10pm - 1:20pm 10 mins
Info
Innovation Live Presentations
CryoVault™ Single-Use Freeze & Thaw Platform
  • Trayce Slumsky - Business Development Manager, Meissner Filtration Products
1:20pm - 1:30pm 10 mins
Info
Innovation Live Presentations
Catalant Theater Showcase
1:30pm - 1:40pm 10 mins
Innovation Live Presentations
Theater Showcase
1:40pm - 1:45pm 5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
  • Stephanie Rieder, PhD - Principal Research Scientist, Process Sciences, AbbVie Bioresearch Center
1:40pm - 1:45pm 5 mins
Speed from Gene to Market
Chairperson's Remarks
  • Gene Lee, PhD - Senior Director and US Site Head, DDTechnologies, Head, Protein & Cell Sceiences/NBE, EMD Serono
1:40pm - 1:45pm 5 mins
Recovery & Purification
Chairperson's Remarks
  • Abhinav Shukla, PhD - Senior Vice President, KBI Biopharma Inc.
1:40pm - 1:45pm 5 mins
Manufacturing Strategy
Chairperson's Remarks
  • Jeffrey Johnson - New Technology Lead and Director, Merck & Co., Inc.
1:40pm - 1:45pm 5 mins
Drug Product, Fill-Finish & Formulations
Chairperson's Remarks
  • Mark Yang, PhD - Director, Global Pharmaceutical Development Biologics, Sanofi
1:40pm - 1:45pm 5 mins
Analytical & Quality
Chairperson's Remarks
  • Melissa Morandi - Vice President, Global Quality, Aegerion Pharmaceuticals
1:40pm - 2:45pm 65 mins
Info
2-Day Training Course: Introduction to BioPharmaceutical Manufacturing
Introduction to BioPharmaceutical Manufacturing*
  • James Dean Vogel - Founder and Director , The BioProcess Institute

Sept 5-6 from 9am-5pm


A comprehensive two-day workshop course on the basic principles and applications used in the production of BioPharmaceutical Products. The course is designed to provide an overview of the technology and parameters affecting process performance and scale-up. Application modules have been designed to demonstrate state-of-art processes. Lectures are integrated into the workshop to stress the scientific and business principles. Specific examples, such as aseptic technique, sterilization, cell growth, product filtration, and product chromatography, are presented to illustrate the problems and solutions encountered in BioPharmaceutical Manufacturing processes.

Attendees range from technically trained employees from other industries who are new to the BioPharmaceutical Industry or want to gain a better understanding of the industry’s technology and Non-Technical employees of the BioPharmaceutical Industry. It will to provide them with a better understanding of the complex Technology to produce a BioPharmaceutical Drug product.

  • Schedule:
  • BioPharmaceutical/Pharmaceutical Industry overview and current trends
  • BioPharmaceutical Process Overview
  • Manufacturing Processes

    • Cell Growth
    • Purification
  • Filtration
  • Chromatography

    • Fill Finish/Drug Product
  • Facility and Support Processes
  • Bioburden and Environmental Risks and Methods for Environmental Control
  • Cleaning, Sanitization and Sterilization
  • cGMP and Regulations

*Separate registration fee required

1:45pm - 2:15pm 30 mins
Cell Culture & Upstream Processing
High Density CHO Perfusion Cultures - Compare the Performance, Highlight the Differences, and Discuss the Challenges Observed when Developing N-1 Perfusion Processes Across Different CHO Cell Lines
  • Caitlin Kurtz - Engineer I, Biogen
1:45pm - 2:15pm 30 mins
Speed from Gene to Market
Simultaneous CHO Cell Clone Selection and Process Development in a Tight Timeline
  • Christopher Miller, MS - Senior Scientist, KBI Biopharma
1:45pm - 2:15pm 30 mins
Recovery & Purification
Viral Vaccine Process Intensification Challenges and How to Overcome Them
  • Paul Ko - Senior Scientist, Cell Technologies , Janssen Research & Development
1:45pm - 2:15pm 30 mins
Info
Manufacturing Strategy
Why Hasn’t the Promise of Single Use Implementation in Commercial Manufacturing Been Fulfilled and what are we doing about the Barriers and Risks?
  • Derek Willson-Parry - Drug Substance Phorum Lead, BioPhorum Operations Group

The promise of Single Use has been realized in process development and clinical manufacturing but less so in commercial manufacturing. Barriers and risks include: Extractables and Leachables; Supplier Changes; Supply Base Reliability; Inconsistent User Requirement Specifications; Inconsistent Testing, Validation, and Quality Release Practices; Supplier Management; and lack of Design Harmonization. The BPOG Disposables Program has developed teams to address each of these risks, and in strong collaboration between biomanufacturers and suppliers is making strong progress towards implementing best practice guidelines on each.

1:45pm - 2:15pm 30 mins
Info
Drug Product, Fill-Finish & Formulations
Single-Use Technologies in Fill-Finish Manufacturing
  • Jeremy Guo, PhD - Fellow, Regeneron

Single Use Technology has increasingly become a dominant strategy in fill/finish with noted benefits in cost saving and flexibility. There are a variety of vendors carrying hundreds of brands catering to a number of cost-sensitive CMOs and a comprehensive evaluation is recommended for innovators to select the correct system for validation and commercial manufacturing.

1:45pm - 2:15pm 30 mins
Info
Analytical & Quality
Investigation of Fc Receptor Binding and Pharmacokinetics of Distinct Fc Glycans
  • Marco Thomann - Senior Scientist, Roche Diagnostics GmbH

Glycosylation of therapeutic proteins is of importance since it can significantly impact biological properties. Glycosylation is heterogeneous and can be subject to batch-to-batch variability. There are a variety of possibilities to influence and investigate glycosylation. In this talk, the in vitro glycoengineering (IVGE) approach will be very briefly introduced and case studies with new data will be presented, including investigation of glyco-modified antibodies incl. changes in galactosylation and sialylation and its impact on Fcy receptor binding and ADCC activity. Furthermore, new results of a recent study on the impact of certain glycan species on animal PK will be shown.

1:45pm - 2:25pm 40 mins
Info
Novel Technology Showcase - Disruptive Downstream Technologies
Virus Safety for Continuous Processing
  • Mark Schofield, Ph.D. - Principal R&D Engineer, Pall Biotech

Continuous bioprocessing is increasingly seen as a means to decrease the cost and increase the quality of biotherapeutics. However, moving to a continuous process raises regulatory concerns. Here we address virus safety for continuous processing holistically, providing performance data and potential validation strategies for virus safety via continuous chromatography, low pH inactivation and virus filtration.

2:15pm - 2:40pm 25 mins
Cell Culture & Upstream Processing
Antibody Reduction and Mitigation for a Novel Antibody
  • Meimei Liu - Scientist, Upstream Development and Operations, Teva Pharmaceuticals
2:15pm - 2:45pm 30 mins
Speed from Gene to Market
Overcoming Challenges for Developing a Platform Process for Early Phase ADC Manufacturing Under Tight Timelines
  • Chi Zhang, PhD - Scientist, Ambrx, Inc.
2:15pm - 2:45pm 30 mins
Recovery & Purification
Handling High Titer Processes and Strategies for DSP Facility Fit
  • Christopher Miller, MS - Senior Scientist, KBI Biopharma
2:15pm - 2:45pm 30 mins
Info
Manufacturing Strategy
Evaluation of Upstream and Downstream Process Methods utilizing Single-Use Technologies
  • Hana Sheikh - Senior Engineer, Global MSAT, Genentech

This presentation will discuss: 1) Which technologies hold strong ROI value benefiting manufacturing, tech transfer and new production introductions? 2) Review of disposables available in US and DS processing 3) Comparing the use of fixed stainless steel technologies in reference to the emerging use of disposables in US + DS processing 4) Evaluating the long-term consequences associated with the introduction of SUS in terms of recurring costs and sustainability and 5) Challenges of single use implementation in a commercial environment.

2:15pm - 2:45pm 30 mins
Info
Drug Product, Fill-Finish & Formulations
Impact of Closed System Transfer Devices to Drug Product Quality: The Importance of Compatibility Testing
  • Frankie Petoskey - Senior Research Associate, Seattle Genetics

Closed System Transfer Devices (CSTDs) present an additional hurdle for the administration of ADCs. A compatibility evaluation of six FDA-approved CSTD devices with reconstituted lyophilized ADC was performed, evaluating physical compatibility to the drug product configuration and administrative route and product quality attributes such as aggregation, charge variants, visible particles, and subvisible particles. Results showed the application of some CSTDs could affect product quality of the drug product, and highlights the importance of compatibility testing these devices.


2:15pm - 2:45pm 30 mins
Info
Analytical & Quality
A Fully Integrated Data Management Platform for Biotherapeutic Analytics to Enhance Data Access and Utilization
  • John Lin - Associate Director, Systems Engineering, Five Prime Therapeutics

Timely delivery of and access to key analytics and characterization data during biotherapeutic development and manufacturing is crucial for informed decision making and resource optimization. At Five Prime Therapeutics, we have developed an integrated data management platform to systematically capture, track, and report analytical and stability study data from both internal and external sources. In house result integration leverages direct interface with instrument and sample prep platform. For outsourced studies, we work closely with our contract manufacturing organizations to standardize and streamline data transfer and intake on a systematic basis. To provide access to real time data, we create interactive dashboard that enables both individual sample profiling, as well as aggregated global analysis across processes and products. Case study will be presented to highlight end-to-end data workflow for an automated, high throughput analytical assay. Fully integrated sample registration, barcode tracking, liquid handler worklist, and instrument readout allow data to be collected and published to the data warehouse seamlessly with no manual user entries, thus increasing operational efficiency and ensuring data integrity.

2:25pm - 2:45pm 20 mins
Info
Novel Technology Showcase - Disruptive Downstream Technologies
A Rapid Process Development Strategy for Continuous Chromatography mAb Bioprocessing
  • Rachel Quesenberry, PhD - Sr R&D Scientist, Pall Biotech

This study demonstrates a strategy for direct implementation of optimized process parameters in streamlined three-step continuous chromatography processes.  A design of experiment approach with single column investigations (batch mode) is used to simulate a multi-column (continuous mode) purification method.  By utilizing this strategy, two robust and predictable continuous monoclonal antibody (mAb) bioprocesses were developed within seven weeks.

2:45pm - 3:15pm 30 mins
Info
Presentation 1
The past and future of managing raw material and process risks in biomanufacturing
  • Nigel Darby - Advisor, GE Healthcare

: Biomanufacturing supply chains are growing quickly to service a rapidly expanding industry delivering critical medical products. The increasing demand for often complex raw materials and a limited ability to change approved processes challenge the entire industry to greater focus on strategies to manage raw material variability and its impact on process performance. The presentation will look at our experience managing the quality of complex raw materials, the challenges of securing their supply, which may require multiple sources, and how we can best secure long-term process robustness. In the near term, this is driven by increased focus on supply chain transparency and management, attention to raw material and process analytics and a robust implementation of QBD in both suppliers and drug manufacturers. Longer term, we expect increasing ability to use raw material and process analytical data to better understand how raw materials impact efficiency and quality in biopharmaceutical manufacturing.

2:45pm - 3:15pm 30 mins
Info
Presentations 2
The Transformation to Excellence - How to Leverage Lean Principles to Improve Single-Use Assembly Product Quality and Supply Security
  • William Faria - Head of Danvers Operations Sara Bell, Senior Marketing Manager, Single-Use Solutions, Millipore Sigma
  • Sara Bell - Senior Marketing Manager, Single Use, MilliporeSigma

Biosimiliars, emerging markets, novel therapies and next generation processing are just a few of the variables affecting the biopharma industry and driving the adoption of single-use technologies. As the usage of single-use technologies increases, suppliers need to continuously improve to meet the stringent requirements of their drug manufacturer customers, as well as ensure capacity to keep pace with single-use growth. From the modification of shift structures to implementing Poka Yoke principles, this presentation will demonstrate how a customer focused mission to boost single-use assembly product quality and supply security, led to a true Center of Excellence, with a more empowered and engaged workforce, increased manufacturing efficiency, improved capacity and a new operational model.

2:45pm - 3:15pm 30 mins
Info
Presentations 3
Monoclonal Antibody Aggregate Removal using Hydrophobic Interaction Chromatography
  • Kelly Flook - Sr Manager, Research & Development, Pharmaceutical Analytics and Purification, Thermo Fisher Scientific

Advances in biotherapeutics are generating more diversified classes of biomolecules that are presenting unique and often difficult purification challenges. To meet industry demand for more differentiated purification tools, a series of Hydrophobic Interaction Chromatography (HIC) resins were developed using extensive user input. Design goals focused on introducing resins addressing typical pain points for current HIC separations such as resolution, capacity and poor product recovery. In monoclonal antibody purification processes, HIC is commonly used as a polishing step offering orthogonal selectivity to ion exchange chromatography for clearance of aggregate, host cell proteins (HCP), and separation of product-related hydrophobic variants. Here we present application data highlighting process development using POROS HIC for high-aggregate mAb polishing. The general approach presented herein can be used to solve similarly complex downstream challenges in other therapeutic modalities.

2:45pm - 3:15pm 30 mins
Info
Presentations 4
Multi-tiered automation for improved efficiency of bioprocess analytics
  • Wesley Straub, PhD - Senior Product Manager, Thermo Fisher Scientific

Accurate, sensitive, and robust analytical data is essential to guiding sound process decisions. The introduction of smaller volume bioreactors and purification columns has produced a record number of samples for contaminant and impurity testing during process development, making analytical testing a key bottleneck. To meet this challenge, new magnetic bead-based chemistries and robotic platforms have been developed. This presentation compares the efficiency gains and required method adaptations required for executing host cell protein (HCP), residual Protein A, and residual DNA methods on fully manual, semi-automated and fully-automated high-throughput platforms. Two case studies will be covered; the first case study describes qualification of a magnetic bead-based semi-automated qPCR residual DNA method that processes up to 24 samples per analyst per day with fewer pipetting steps, while the second case study describes implementation of a new fully-automated system that analyzes 300 samples of either HCP, residual DNA or residual Protein A per day per analyst with zero pipetting steps.

2:45pm - 3:15pm 30 mins
Info
Presentations 5
Concurrent Technology Workshops #5
2:45pm - 3:15pm 30 mins
Info
2-Day Training Course: Introduction to BioPharmaceutical Manufacturing
Introduction to BioPharmaceutical Manufacturing*
  • James Dean Vogel - Founder and Director , The BioProcess Institute

Sept 5-6 from 9am-5pm


A comprehensive two-day workshop course on the basic principles and applications used in the production of BioPharmaceutical Products. The course is designed to provide an overview of the technology and parameters affecting process performance and scale-up. Application modules have been designed to demonstrate state-of-art processes. Lectures are integrated into the workshop to stress the scientific and business principles. Specific examples, such as aseptic technique, sterilization, cell growth, product filtration, and product chromatography, are presented to illustrate the problems and solutions encountered in BioPharmaceutical Manufacturing processes.

Attendees range from technically trained employees from other industries who are new to the BioPharmaceutical Industry or want to gain a better understanding of the industry’s technology and Non-Technical employees of the BioPharmaceutical Industry. It will to provide them with a better understanding of the complex Technology to produce a BioPharmaceutical Drug product.

  • Schedule:
  • BioPharmaceutical/Pharmaceutical Industry overview and current trends
  • BioPharmaceutical Process Overview
  • Manufacturing Processes

    • Cell Growth
    • Purification
  • Filtration
  • Chromatography

    • Fill Finish/Drug Product
  • Facility and Support Processes
  • Bioburden and Environmental Risks and Methods for Environmental Control
  • Cleaning, Sanitization and Sterilization
  • cGMP and Regulations

*Separate registration fee required

3:15pm - 4:00pm 45 mins
Main Conference
Networking Refreshment Break in Exhibit Hall
3:15pm - 3:25pm 10 mins
Info
Innovation Live Presentations
FujiFilm Theater Showcase
3:25pm - 3:35pm 10 mins
Info
Innovation Live Presentations
Exploration of anti-aggregation and protein stabilization properties of novel carbohydrates.
  • Sofiya Yashchuk, PhD - Technical Applications Specialist, Roquette

Physical stability of therapeutic proteins is typically addressed by formulating with sucrose, trehalose, and sorbitol; known to help prevent protein unfolding, structure loss, and aggregation. We investigated the stabilizing effects of novel carbohydrate tools KLEPTOSE® HPB and HP (hydroxypropyl-ß-cyclodextrins with MS=0.65 and MS=0.9 respectively). Using DOE high-throughput formulation screening method (iFormulate™) paired with nanoDSF (Differential Scanning Fluorimetry) we examined their influence on the thermal stability of the human growth hormone (hGH) and the monoclonal antibody (mAb) Infliximab.

3:35pm - 3:45pm 10 mins
Innovation Live Presentations
Theater Showcase
3:45pm - 3:55pm 10 mins
Innovation Live Presentations
Theater Showcase
4:00pm - 4:25pm 25 mins
Cell Culture & Upstream Processing
Development of a Clone Selection and Media Optimization Strategy to Convert a Roller Bottle Process to a Suspension Bioreactor Process
  • Pubali Banerjee, PhD - Senior Upstream Development Engineer, Shire LLC
4:00pm - 4:25pm 25 mins
Info
Speed from Gene to Market
Analytical Characterization Strategy utilizing Mass Spectrometry for Construct Screening at Early Stage to Minimize Potential CMC Challenges
  • Gary Li, PhD - Principal Scientist, Aptevo Therapeutics

LC-MS is a powerful protein characterization tool that can be used to identify post-translational modifications (PTMs) on proteins during the clone selection process. An early read on product quality during clone selection can help avoid CMC pitfalls that can result in costly delays. PTMs can be sequence-dependent and by identifying these PTMs during the sequence optimization stage, enables the selection of constructs with more desirable product quality attributes. Four examples will be shown that highlight the use of mass spectrometry to confirm the presence of expected PTMs such as N-glycosylation of the Fc region in mAb-like molecules, as well as to screen out undesirable PTMs such as proline hydroxylation. These case studies demonstrate that in-depth characterization using mass spectrometry early in the development process can mitigate potential CMC risks and enable the product development and IND timelines to stay on track. 1. Identification of N-terminal pyroglutamate formation – an expected PTM 2. Cleavage site identification to minimize cleavages and increase protein yield 3. Proline hydroxylation PTM – an undesirable PTM 4. O-glycan PTM identification — selecting constructs with low levels of O-glycosylation for reducing manufacturing risk

4:00pm - 4:25pm 25 mins
Recovery & Purification
Paul Jorlorian
  • Paul Jorjorian, MEng - Senior Director, Patheon
4:00pm - 4:25pm 25 mins
Info
Manufacturing Strategy
Single Use Systems: Challenges to Implementation and How to Overcome Them
  • Gregory Naugle, MSc. - Executive Director, Merck

Single use systems in biopharmaceutical manufacturing processes are becoming increasingly prevalent and offer a variety of advantages throughout the product lifecycle. However deployment of these technologies can present a variety of operational and logistical challenges. This talk will discuss some of these challenges and how to address them prospectively and throughout the commercialization process.

4:00pm - 4:25pm 25 mins
Info
Drug Product, Fill-Finish & Formulations
New Innovations in Fill/Finish and Drug Product Manufacturing
  • Mark Yang, PhD - Director, Global Pharmaceutical Development Biologics, Sanofi

Significant progress has been made in biopharmaceutical fill finish processes in the past a few years. This presentation will highlight and review the major advancement in these field, including new formulation strategies, novel container/closure system, (gloveless) isolator, single-use components, multi-format flexible fillers, new lyophilization and drying technologies, in-line process monitoring, and new product inspection equipment.

4:00pm - 4:25pm 25 mins
Info
Analytical & Quality
Analytical Characterization Strategy utilizing Mass Spectrometry for Construct Screening at Early Stage to Minimize Potential CMC Challenges
  • Gary Li, PhD - Principal Scientist, Aptevo Therapeutics

LC-MS is a powerful protein characterization tool that can be used to identify post-translational modifications (PTMs) on proteins during the clone selection process. An early read on product quality during clone selection can help avoid CMC pitfalls that can result in costly delays. PTMs can be sequence-dependent and by identifying these PTMs during the sequence optimization stage, enables the selection of constructs with more desirable product quality attributes. Four examples will be shown that highlight the use of mass spectrometry to confirm the presence of expected PTMs such as N-glycosylation of the Fc region in mAb-like molecules, as well as to screen out undesirable PTMs such as proline hydroxylation. These case studies demonstrate that in-depth characterization using mass spectrometry early in the development process can mitigate potential CMC risks and enable the product development and IND timelines to stay on track. 1. Identification of N-terminal pyroglutamate formation – an expected PTM 2. Cleavage site identification to minimize cleavages and increase protein yield 3. Proline hydroxylation PTM – an undesirable PTM 4. O-glycan PTM identification — selecting constructs with low levels of O-glycosylation for reducing manufacturing risk

4:00pm - 5:00pm 60 mins
Info
2-Day Training Course: Introduction to BioPharmaceutical Manufacturing
Introduction to BioPharmaceutical Manufacturing*
  • James Dean Vogel - Founder and Director , The BioProcess Institute

Sept 5-6 from 9am-5pm


A comprehensive two-day workshop course on the basic principles and applications used in the production of BioPharmaceutical Products. The course is designed to provide an overview of the technology and parameters affecting process performance and scale-up. Application modules have been designed to demonstrate state-of-art processes. Lectures are integrated into the workshop to stress the scientific and business principles. Specific examples, such as aseptic technique, sterilization, cell growth, product filtration, and product chromatography, are presented to illustrate the problems and solutions encountered in BioPharmaceutical Manufacturing processes.

Attendees range from technically trained employees from other industries who are new to the BioPharmaceutical Industry or want to gain a better understanding of the industry’s technology and Non-Technical employees of the BioPharmaceutical Industry. It will to provide them with a better understanding of the complex Technology to produce a BioPharmaceutical Drug product.

  • Schedule:
  • BioPharmaceutical/Pharmaceutical Industry overview and current trends
  • BioPharmaceutical Process Overview
  • Manufacturing Processes

    • Cell Growth
    • Purification
  • Filtration
  • Chromatography

    • Fill Finish/Drug Product
  • Facility and Support Processes
  • Bioburden and Environmental Risks and Methods for Environmental Control
  • Cleaning, Sanitization and Sterilization
  • cGMP and Regulations

*Separate registration fee required

4:25pm - 4:50pm 25 mins
Cell Culture & Upstream Processing
Increased MSX Level Altered CHO Cell Metabolism and Improved Productivity and Production Stability: A Strategy for Industrial Bioprocessing Yield Improvement
  • Jun Tian, PhD - Senior Scientist, Bristol-Myers Squibb
4:25pm - 4:50pm 25 mins
Speed from Gene to Market
Product Quality Control Strategy by Using Combinatorial Cell Engineering and OMICS Screening Tools
  • Zhimei Du, PhD - Director, Merck & Co
4:25pm - 4:50pm 25 mins
Info
Recovery & Purification
Scalable Single Use Upstream and Downstream platform for reducing time to market of Intensified and Continuous Processes
  • Gerben Zijlstra, Ph.D - Platform Marketing Manager, Sartorius Stedim Biotech
4:25pm - 4:50pm 25 mins
Manufacturing Strategy
We Need to Talk about Disposables: Considerations and Challenges in Adopting Disposable Equipment for Commercial Biomanufacturing
  • Gerald Kierans - Director, Technical Services, Pfizer Global Supply, Pfizer
4:25pm - 4:50pm 25 mins
Info
Drug Product, Fill-Finish & Formulations
Case Study: Filling in Vapor Phase Hydrogen Peroxide (VPHP)-Sanitized Isolator – VPHP Uptake and Impact on Monoclonal Antibody (mAb) Drug Product Quality
  • Yuh-Fun Maa, PhD - Senior Principal Engineer, Genentech

A mAb drug product was transferred to a manufacturing site with a VPHP-decontaminated isolator filling core. Under the quality-by-design risk tool, a combination of small-scale and manufacturing-scale studies was performed to evaluate how key process parameters affected hydrogen peroxide uptake behaviors. This study justified the setting of process parameter acceptable ranges that mitigated the risk on product quality under the worst-case scenario.

4:25pm - 4:50pm 25 mins
Analytical & Quality
Product Quality Control Strategy by Using Combinatorial Cell Engineering and OMICS Screening Tools
  • Zhimei Du, PhD - Director, Merck & Co
4:50pm - 5:15pm 25 mins
Cell Culture & Upstream Processing
Monoclonal Antibody Disulfide Bond Reduction and Re-Oxidation by Copper Sulfate During Manufacturing and Impact on Product Quality
  • Green Zhang, PhD - Associate Director, Large Molecule Purification, Incyte Corporation
4:50pm - 5:15pm 25 mins
Speed from Gene to Market
A Layered Approach to Early Process Development – Strategies for a Non-Platform Antibody
  • Abraham Friedman, PhD - Early Stage Process Development, Alexion Pharmaceuticals, Inc.
4:50pm - 5:15pm 25 mins
Recovery & Purification
Digital Tools Leverage Research Knowledge for De Novo Downstream Process Design
  • Rushd Khalaf, PhD - PostDoc, Novartis Pharma
4:50pm - 5:15pm 25 mins
Info
Manufacturing Strategy
Single Use Manufacturing within the Bristol-Myers Squibb Manufacturing Network – Preparing for Commercial Production
  • Lance Marquardt - Manager, Upstream Processing, Bristol-Myers Squibb

An overview of the current use of single use manufacturing within the Bristol-Myers Squibb manufacturing networks and planned future state.  The challenges in implementing single use manufacturing for commercial production will be discussed.  Comparisons will be made to the implementation of past improvements and the plans for future improvements, such as continuous processing.

4:50pm - 5:15pm 25 mins
Info
Drug Product, Fill-Finish & Formulations
An Industry-wide Risk Assessment Framework and Standardized Methodology for Particle Classification in Biopharmaceutical Parenteral Products
  • Arun Jangda - External Supply Operation Lead, Shire

It is generally perceived that particles in parenteral products represent a risk. Particulates in parenteral biopharmaceuticals are a major cause of product recalls. Appropriate management of particulate risk is vital in ensuring patient safety and product supply. BPOG has conducted cross-Industry surveys, examining the issue of how particles are assessed in biopharmaceutical products. In common with other, similar, surveys (e.g. PDA)[1], it is clear that there are differences in practice across the industry. This best practice paper helps to guide in creating a standardized methodology and developing a tool for assessing risk, develop a route through which industry can present a clear and consistent approach. The Standardized Methodology and Risk Classification tool are intended to have utility for all biopharmaceutical parenteral products, and for all visible particles that might reasonably be found at visual inspection during their manufacture.


4:50pm - 5:15pm 25 mins
Analytical & Quality
A Layered Approach to Early Process Development – Strategies for a Non-Platform Antibody
  • Abraham Friedman, PhD - Early Stage Process Development, Alexion Pharmaceuticals, Inc.
5:15pm - 5:40pm 25 mins
Cell Culture & Upstream Processing
Maintaining Product Quality from Early to Late Stage Process Development
  • Jason Goodrick - Senior Engineer, Late Stage Cell Culture, Genentech, Inc.
5:15pm - 5:40pm 25 mins
Speed from Gene to Market
Achieving the Industry’s Shortest Timelines to IND
  • Galahad Deperalta - Senior Scientist, Protein Analytical Chemistry, Genentech, a member of the Roche Group
5:15pm - 5:40pm 25 mins
Recovery & Purification
Streamlining Process Validation through Prior Knowledge: A Case Study in Buffer & Process Solution Chemical Stability & Hold Times
  • James Patch, Ph.D. - Senior Engineer, Genentech, Inc.
5:15pm - 5:40pm 25 mins
Info
Manufacturing Strategy
How SUBs and SUMs can be QC Micro and EHS’s Best Friends
  • Katherine Leitch - Director of Technical Services, Alexion

Single-use Bioreactors (SUBs) and Single-use Mixers (SUMs) offer significant advantages for bioburden control and reduced hazards from an Environmental, Health, and Safety (EHS) perspective. This presentation will explore Alexion’s experiences with single-use technology in external manufacturing and as part of an on-going capital project at Alexion Athlone Manufacturing Facility.

5:15pm - 5:40pm 25 mins
Drug Product, Fill-Finish & Formulations
QbD Approach to Develop and Scale Up Lyophilized Protein Therapeutics
  • Bingquan (Stuart) Wang, PhD - Director, Moderna Therapeutics
5:15pm - 5:40pm 25 mins
Analytical & Quality
Achieving the Industry’s Shortest Timelines to IND
  • Galahad Deperalta - Senior Scientist, Protein Analytical Chemistry, Genentech, a member of the Roche Group
5:40pm - 6:30pm 50 mins
End of Conference Sessions for the Day
6:30pm - 9:30pm 180 mins
Info
Biotech Week Boston Festival Party @ Royale

Don’t miss the Biotech Week Boston Festival Party at The Royale nightclub. This is the only event where you can kick back, and meet attendees from ALL of the official events that are part of Biotech Week Boston. Unwind, network in a fun atmosphere, and enjoy an evening of rock and roll, complete with a headline band.

*This event is free-to-attend for all registered attendees, however space is limited and available on a first-come, first-serve basis.

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5:40pm - 6:30pm

End of Conference Sessions for the Day

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6:30pm - 9:30pm
Info

Biotech Week Boston Festival Party @ Royale

Don’t miss the Biotech Week Boston Festival Party at The Royale nightclub. This is the only event where you can kick back, and meet attendees from ALL of the official events that are part of Biotech Week Boston. Unwind, network in a fun atmosphere, and enjoy an evening of rock and roll, complete with a headline band.

*This event is free-to-attend for all registered attendees, however space is limited and available on a first-come, first-serve basis.

More