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Key Sessions

Rebecca Sendak, PhD

Accelerating the Time to Clinic for Complex Biological Modalities

Sanofi

Zachary Shriver, PhD

Developing Monoclonal Antibodies for Influenza

Visterra, Inc.

Robert Langer, ScD

High-Impact Ideas and Use-Inspired Research - A Chat with MIT's Bob Langer on How to Create Innovations That Matter

Massachusetts Institute of Technology

E. Morrey Atkinson, PhD

Driving Value with Process and Facility Intensification: Moving from Current- to Next- Generation Bioprocessing

Bristol-Myers Squibb

Elsie DeBella, PhD

The Complex World of Biosimilar Process Development

Momenta Pharmaceuticals

Sep 05
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7:00am - 8:00am

Registration and Coffee

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Showing of Streams
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Showing of Streams
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Showing of Streams
5:00pm - 7:00pm
Info

Grand Opening of the Poster & Exhibit Hall and Cocktail Reception

Connect with thousands of like-minded attendees, speakers, sponsors and exhibitors during the grand opening of our exhibit hall.  Enjoy a decadent display of hors d'oeuvres and grab a glass of wine/beer as our exhibitors showcase today's latest technologies in bioprocessing.

Access to this event is included with all conference registrations.

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7:00am - 8:00am 60 mins
Registration and Coffee
8:00am - 8:20am 20 mins
Plenary Session- Driving Down Costs in Bioprocessing
Conference Opening and Welcome
  • Günter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden
8:20am - 8:50am 30 mins
Info
Plenary Session- Driving Down Costs in Bioprocessing
Accelerating the Time to Clinic for Complex Biological Modalities
  • Rebecca Sendak, PhD - US Head of BioPharmaceutics Development, Sanofi

The Biopharmaceutical industry has seen an increasing complexity in biologics being brought to the market over the past several years. At the same time, speed to clinic is crucial for remaining competitive and supporting as many “shots on goal” to evaluate clinical candidates. Innovative approaches and flexible platforms can help achieve the required agility and speed needed to support the challenging array of biologics the industry is seeing today.

8:50am - 9:20am 30 mins
Plenary Session- Driving Down Costs in Bioprocessing
Developing Monoclonal Antibodies for Influenza
  • Zachary Shriver, PhD - Chief Scientific Officer, Visterra, Inc.
9:00am - 9:45am 45 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

9:20am - 9:45am 25 mins
Info
Plenary Session- Driving Down Costs in Bioprocessing
PANEL DISCUSSION: Production Economics - Cost of Ownership
  • Tom Ransohoff - Vice President & Senior Consultant, Bioprocess Technology Consultants
  • Jorg Thommes, PhD - Head of CMC, Bill & Melinda Gates Medical Research Institute
  • Rebecca Sendak, PhD - US Head of BioPharmaceutics Development, Sanofi
  • E. Morrey Atkinson, PhD - VP/Head of Internal Commercial Manufacturing, Biologics, Bristol-Myers Squibb
  • Günter Jagschies, Ph.D. - Senior Director, Strategic Customer Relations, GE Healthcare, Sweden

This panel will explore the drivers, challenges and potential approaches for reducing the costs of biologic medicines. Specifically, the role of new technologies, obstacles to implementation of lower cost manufacturing approaches and the potential for greater collaboration across industry stakeholders in the pursuit of this goal.

9:45am - 10:10am 25 mins
Main Conference
Networking Refreshment Break and Book Signing
9:45am - 10:10am 25 mins
Info
Breakfast Session
Understanding the science behind liquid leak and microbial ingress mechanisms as the foundation for single use container closure integrity (SU-CCI)
  • Jean-Marc Cappia - Group Vice President Marketing & Product Management, Sartorius Stedim Biotech
  • Carole Langlois - Senior Product Manager, Fluid Management Technology, Sartorius Stedim Biotech FMT SAS
  • Marc Hogreve - Senior Engineer Integrity Testing, Sartorius Stedim Biotech

This presentation describes a scientific approach to establishing a relation between liquid leakage and microbial ingress mechanisms in single use plastic containers and developing the appropriate physical integrity testing methods and specifications.

With the expansion of Single Use Systems (SUS) in all process steps of commercial manufacturing, integrity failure can significantly impact drug safety, availability and costs. Consequently, there is an increasing industry scrutiny on SU CCI, raising the need to develop good science behind liquid leakage and microbial ingress and appropriate physical integrity testing technologies.

The authors will first review the emerging industry association’s initiatives and introduce an integrated quality by design, material science and process control approach as the pre requisite to SU-CCI.

 

The presentation will then describe how applying good science help determine the maximum allowable leakage limit (MALL) under which no product leakage and no bacteria ingress occur with SUS under various fluids and process conditions. The understanding of liquid leakage and bacteria ingress mechanisms also enables to validate robust liquid leak tests and microbial aerosol challenge that both are correlated to the detection limits of physical integrity testing methods.

The authors will conclude with the development of highly sensitive deterministic integrity testing technologies such as gas tracer detection and pressure decay able to detect the MALL determined during the scientific study. Helium based Supplier Integrity Test (SIT) for instance is able to control the finished products with a detection limit of 2µm and is correlated to both liquid leakage and microbial ingress under all tested process conditions.


Space limited, first come first serve

9:45am - 10:10am 25 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

10:10am - 10:15am 5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
  • Susan Jones, PhD - Vice President and Principal Consultant, BioProcess Technology Consultants
10:10am - 10:15am 5 mins
Speed from Gene to Market
Chairperson's Remarks
  • Susan Jones, PhD - Vice President and Principal Consultant, BioProcess Technology Consultants
10:10am - 10:15am 5 mins
Recovery & Purification
Chairperson's Remarks
  • John Moscariello - Senior Director of Viral Vector and Gene Editing Process Development, Juno Therapeutics, Inc
10:10am - 10:15am 5 mins
Manufacturing Strategy
Chairperson's Remarks
  • Andrew Seipel, PhD - Senior Manager, Regulatory Affairs CMC, Biogen
10:10am - 10:15am 5 mins
Drug Product, Fill-Finish & Formulations
Chairperson's Remarks
  • Arvind Srivastava, PhD - Vice President, Avantor, Inc.
10:10am - 10:15am 5 mins
Analytical & Quality
Chairperson's Remarks
  • Bo Yan, PhD - Senior Scientist I, AbbVie Bioresearch Center
10:10am - 11:45am 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

10:15am - 10:45am 30 mins
Cell Culture & Upstream Processing
Seamless Integration of Projects Between R&D and Manufacturing
  • Gene Lee, PhD - Senior Director and US Site Head, DDTechnologies, Head, Protein & Cell Sceiences/NBE, EMD Serono
10:15am - 10:45am 30 mins
Speed from Gene to Market
Seamless Integration of Projects Between R&D and Manufacturing
  • Gene Lee, PhD - Senior Director and US Site Head, DDTechnologies, Head, Protein & Cell Sceiences/NBE, EMD Serono
10:15am - 10:45am 30 mins
Recovery & Purification
Implementing Lean in Process Development: Beyond 5S
  • Paul Jorjorian, MEng - Senior Director, Patheon
10:15am - 10:45am 30 mins
Info
Manufacturing Strategy
Cell Culture Manufacturing Continuous Process Improvement: Enhancing the Control Capability of Product Quality Attributes for Marketed Biopharmaceutical Product Lifecycle
  • Ting-Kuo Huang, PhD - Senior Engineer, Genentech

During biopharmaceutical process development and commercialization, the Process Validation lifecycle is started with Process Design (Stage 1), then followed by Process Performance Qualification (Stage 2) and monitored through Continued Process Verification (Stage 3) for a marketed biologics product. The CPV (Continued Process Verification), per Stage 3 of FDA Process Validation guidance, provides further assurance that a validated process remains in a state of control during the routine GMP manufacturing of a marketed biologics product lifecycle. Raw material lot-to-lot variability may potentially lead to unexpected impact on the cell culture manufacturing process performance and/or product quality attributes (e.g., slower cell growth, low titer performance and/or drifting or shifting of product quality attributes, etc.). Therefore, the manufacturing process performance and product quality attributes (PQA) are continuously monitored, verified and controlled throughout the marketed biologics product lifecycle. In this presentation, an industry case study will discuss: how a cell culture manufacturing process improvement was identified, evaluated and implemented for stabilizing and controlling the drug substance PQAs to mitigate the potential impact of raw material variability for a marketed biologics product. Multivariate data analysis, scale-down model approaches and commercial scale process validation were employed, developed and executed to improve the control capability of PQAs. The key findings presented in this study are intended to enhance biopharmaceutical manufacturing process knowledge, which is valuable for all partners across the cell culture manufacturing network.

10:15am - 10:35am 20 mins
Info
Drug Product, Fill-Finish & Formulations
Managing Viscosity for High Concentration Protein Formulations
  • Arvind Srivastava, PhD - Vice President, Avantor, Inc.

An Increase in viscosity is a major challenge in developing high concentration formulations for proteins. The presentation will discuss a viscosity reduction strategy for proteins.

10:15am - 10:45am 30 mins
Info
Analytical & Quality
Mass Spectrometry in Support of Developability and Clone Selection: Automation, Analysis and Interpretation
  • Yan Jiang, PhD - Senior Scientist, BioAnalytics Characterization, Sanofi BioPharmaceutics Development

Identification of important quality attributes and potential risks using mass spectrometry (MS)-based analysis during early stage developability assessment and clone selection, would greatly aid the timely decision making and avoid delays in development timelines. Here we report a high-throughput workflow for fast characterization screening, which includes automated antibody purification, sample preparation and digestion, and MS data analysis to reduce the turnaround time for large sets of samples and improve the analytical efficiency.

10:35am - 11:00am 25 mins
Info
Drug Product, Fill-Finish & Formulations
Development of Subcutaneous Formulations of mAbs and Recombinant Hyaluronidase: Strategies and Lessons Learned
  • Jeremy Duboeuf - Senior Scientist and Group Leader, Roche

Overcoming high dose monoclonal antibody formulations for subcutaneous administration by use of recombinant hyaluronidase as permeation enhancer. Challenges of co-formulation development and manufacturing process considerations.

10:45am - 11:15am 30 mins
Cell Culture & Upstream Processing
Enhancing Speed in Development by Early Quality Assessment of Biologics
  • Daniel Heitmann, PhD - Head Portfolio and Project Management IBP, Novartis Pharma AG
10:45am - 11:15am 30 mins
Speed from Gene to Market
Enhancing Speed in Development by Early Quality Assessment of Biologics
  • Daniel Heitmann, PhD - Head Portfolio and Project Management IBP, Novartis Pharma AG
10:45am - 11:15am 30 mins
Recovery & Purification
Maximizing Productivity of Protein A Capture
  • Rushd Khalaf, PhD - PostDoc, Novartis Pharma
10:45am - 11:15am 30 mins
Info
Manufacturing Strategy
Reducing Risk to CQA Out of Specification Result for a Commercialized Enzyme Replacement Therapy
  • Sarah Holtschlag - Head of Global Product Support, Shire Pharmaceuticals

Process capability analysis is often utilized in the biotechnology industry to determine the risk to meeting release specifications.  This case study will discuss the process improvement plan for a commercial process to reduce the risk of an out of specification result for a specific CQA.

10:45am - 11:15am 30 mins
Analytical & Quality
Understanding the Propensity of Sequence Variants During Cell Line and Culture Process Development
  • Lisa Marzilli, PhD - Associate Research Fellow and group leader, Pfizer, USA
11:00am - 11:25am 25 mins
Drug Product, Fill-Finish & Formulations
Formulation and Device Approaches to Design a Formulation for Subcutaneous Administration
  • Nagarajan (Raja) Thyagarajapuram, PhD - Research Advisor, Group Leader, Eli Lilly and Company
11:15am - 11:45am 30 mins
Cell Culture & Upstream Processing
Target Integrated Cell Line Development Platform Process and Associated Speed and Efficiency Benefits
  • Amy Shen, PhD - Principal Scientist, Genentech Inc.
11:15am - 11:45am 30 mins
Speed from Gene to Market
Target Integrated Cell Line Development Platform Process and Associated Speed and Efficiency Benefits
  • Amy Shen, PhD - Principal Scientist, Genentech Inc.
11:15am - 11:45am 30 mins
Recovery & Purification
Downstream Process Adaptions for Production for an Antibody
  • Bala Thangaraj, PhD - Scientist, Amgen Inc.
11:15am - 11:45am 30 mins
Info
Manufacturing Strategy
Regulatory Lifecycle Management Strategies for Recently Commercialized Biologics
  • Andrew Seipel, PhD - Senior Manager, Regulatory Affairs CMC, Biogen

The nature of the pharmaceutical environment is such that optimization of the manufacturing process, supply chain or patient experience often occurs after commercialization. Integration of the regulatory strategy with the lifecycle management (LCM) and commercial plan is critical to ensure that manufacturers have the flexibility to optimize their process and products and adapt to unforeseen challenges for recently commercialized products. Review of global registration and post-approval variation submissions for biologics launched within the last 5 years has identified the regulatory complexities and challenges unique to lifecycle management of new products. The analysis presented demonstrates the impact upon LCM by marketing application review timelines, non-harmonized regulatory guidelines, GMP requirements and other factors. Novel strategies and best practices critical to maximizing flexibility within a continuously shifting global regulatory landscape are highlighted.

11:15am - 11:45am 30 mins
Info
Analytical & Quality
Rapid Characterization of Biotherapeutics using Capillary Electrophoresis Mass Spectrometry
  • Bo Yan, PhD - Senior Scientist I, AbbVie Bioresearch Center

We applied a microfluidic capillary electrophoresis (CE) device coupled with MS for rapid characterization of biotherapeutics, such as monoclonal antibodies (mAbs), fusion proteins, and protein mixtures. This method provides fast separation, different elution profile relative to LC, and exceptional sensitivity for peptide mapping and post-translational modification detection of biotherapeutics.

11:25am - 11:45am 20 mins
Drug Product, Fill-Finish & Formulations
Impact of Metals and Light on Stability of Biopharmaceuticals
  • Ashaben Patel, PhD - Scientist, Large Molecule Drug Product Development, Janssen Research & Development
11:50am - 12:20pm 30 mins
Info
Workshop 1
Striving for bioprocessing excellence – balancing modern approaches to manufacturing
  • Fredrik Lundström - Product Manager, GE Healthcare, Sweden

With the anticipated growth in diversity of molecules entering the clinical pipeline, and the ever-increasing pressure to improve manufacturing productivity, flexibility, and cost efficiency, there will be a relentless focus on implementing different processing tools and manufacturing approaches to achieve improved process outcomes.

However, there is no silver bullet that can address all types of production scenarios. Instead, effective outcomes can only be achieved through targeted implementation of processing tools. This session will discuss existing and new single-use technologies coming to the market. It will focus on the benefits of choosing each processing tool with the goal of achieving desired outcomes.

11:50am - 12:20pm 30 mins
Info
Workshop 2
Application of the OMNIVAX high productivity, low-cost vaccine manufacturing platform for epidemic preparedness
  • Renaud Jacquemart, PhD - Project Director, Project Office, Batavia Biosciences

The OMNIVAX platform is characterized by streamlined process architecture, fully disposable and high productivity technologies implemented in a microfacility. OMNIVAX has demonstrated the potential to produce 40-60M doses of trivalent inactivated Polio vaccine for an overall cost of $0.25/dose, and is now applied to develop novel, viral vector-based vaccines to prevent and contain infectious disease epidemics.

11:50am - 12:20pm 30 mins
Info
Workshop 3
Diminishing Single-Use Bag Failures in Cryo Applications Through Polymer Science
  • Andrew Quick - Product Manager, Entegris

This presentation will discuss the unique characteristics that polymers bring to single-use bioprocessing applications.  Included will be polymeric material performance data demonstrating toughness, purity, chemical resistance, gamma stability and cold temperature capabilities of single-use polymers along with guidance on how to leverage fluoropolymers to eliminate bag failures in cryo applications.

11:50am - 12:20pm 30 mins
Info
Workshop 4
Implications of Choosing the Right Cell Engineering Technology on Biotherapeutic Development
  • Joan Foster, PhD - Senior Field Applications Scientist, MaxCyte

Are increasing productivity and maximizing data relevance mutually exclusive during biotherapeutic development when working in an environment of limited resources?  Not necessarily if you can work with the manufacturing host cell early in development to produce sufficient quantities of candidates for extensive characterization and thus progression of the most promising candidates in a cost-efficient manner. One often overlooked aspect of success is employing the right means of cell engineering, such as MaxCyte’s high-performance, cell engineering technology, to drive rapid, scalable production of even the most difficult-to-express proteins in the manufacturing cell background while maintaining flexibility in downstream culture processes. This presentation discusses how the high performance and flexibility of MaxCyte’s cell engineering technology positively impacts therapeutic efficacy, laboratory productivity, and fast-tracks biotherapeutic development.

11:50am - 12:20pm 30 mins
Info
Workshop 5
Recent Developments in Automated High Throughput Process Development
  • Simon Fogarty - DIRECTOR OF APPLICATION SCIENCES, TECAN

Time to market is crucial in process development, and many companies developing and manufacturing therapeutic agents have invested in automated protein purification and high throughput bioprocessing. The miniaturization and parallelization capabilities of Tecan’s liquid handling platforms ensure an excellent understanding of bioprocesses for robust scale-up into manufacturing, enabling cost-effective development.

11:50am - 12:20pm 30 mins
Info
Workshop 6
From DNA Sequence to GMP Manufacturing – A Year-Long Upstream Case Study
  • Christa Short - Senior Scientist, Cytovance Biologics

Leveraging experience and collaborative decision making to select a rapid yet thorough development path from DNA sequence to a manufacturable process for a therapeutic monoclonal antibody. An outline for strategic decision making of upstream development will be presented.

11:50am - 12:20pm 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

12:20pm - 1:25pm 65 mins
Info
Presentation 1
Particles and Extractables; Aspects Beyond Measurement of Contaminants
  • Armin Hauk, PhD - Lead Scientist Extractables & Leachables, Sartorius-Stedim-Biotech
  • Klaus Wormuth, PhD - Lead Scientist, Sartorius Stedim Biotech

Talk # 1: THE PROPER USE OF EXTRACTBALES DATA - ASPECTS BEYOND EXTRACTABLES-MEASUREMENT

Aspects which go far beyond the pure extractables measurement will be discussed. In particular for SUS/SUT it is required to establish algorithm for scaling and combination of extractables data, for devices of different sizes and assemblies. In addition the quantitative use of extractables data in risk assessments will be discussed. The presented methodology is based on physical principles rather than an intuitive "worst case" approach.

-Armin Hauk

Talk #2: Minimizing the risk of particulate contamination of biopharmaceuticals from single-use processing equipment

Through a holistic measurement and prevention approach, Sartorius strives to reduce particulate contamination risks involved in the application of single-use systems (SUS) in biopharmaceutical processing. For particulate prevention during the manufacturing of SUS, quality by design, supplier quality, cleanroom operations, inspection processes and measurement methods all play critical roles. Challenges and results from these initiatives are highlighted in this presentation.

-Klaus Wormuth 

12:20pm - 1:25pm 65 mins
Info
Presentation 2
Best practices to ensure speed, quality and security for externalized R&D services.
  • Brian Bonnell, MBA - Vice President Strategic Partnerships, Scientist.com

Leveraging CROs effectively is critical to accelerating drug discovery and development, yet Externalization presents challenges:  suppliers change, regulations evolve, and research organizations must protect IP, reputation and employees. See how leading pharmaceutical companies and innovative biotechs have already streamlined the way they identify, qualify and engage with CROs to ensure speed, quality and security in their R&D pipeline.

12:20pm - 1:25pm 65 mins
Info
Presentation 3
A Challenge with Single-Use Technology: Protecting Bulk Drug Substance (DS) during cold chain handling, storage, and transport
  • Joe Cintavey, BSME/MBA University of Cincinnati - Product Specialist, Gore & Associates

The issue of single-use container durability during cold chain handling is well known in the biopharmaceutical market, particularly at freeze and transport temperatures down to -80°C.  The extractables and leachables profile of materials commonly used in containers is another concern.  This presentation will discuss novel technologies that address both the durability and purity challenge that biopharmaceutical manufacturers face.

12:20pm - 1:25pm 65 mins
Info
Presentation 4
Introducing Chromassette®, a modular chromatography platform enabling next-generation bioprocess purification
  • Guido Ströhlein, PhD, MBA - Global Director Technology and Development, JSR Micro NV
  • Masayoshi Nagaya - Senior Global Manager, Separation Science Group (SSG), JSR Micro Inc
  • Ping Huang, PhD - Director, Abbvie

We will introduce Chromassette® and an application example of an integrated rapid single pass process from harvest to purified bulk, a concept demonstrated by AbbVie. Chromassette is a stackable, single-use and pre-packed chromatography cassette with a supported bed, addressing the current key challenges in manufacturing. Chromassette enhances the separation capabilities of chromatography resins and combines it with the convenience of a modular cassette.

12:20pm - 1:25pm 65 mins
Info
Presentation 5
Effective supplier collaborations to enhance productivity in biopharmaceutical production
  • Ashish Kulkarni, PhD - Executive Vice President, Chief Technology Officer, Avantor

Supplier enabled innovation through effective strategic collaborations is critical in value creation for the biopharmaceutical industry. From drug substance to drug product raw materials, ready to use packaging, all the way though digital tools, a robust supplier innovation process brings to the collaboration examples and results which directly impact manufacturing productivity.

12:20pm - 1:20pm 60 mins
Info
Presentation 6
Reliable data in a high throughput workflow.
  • Matthew Rehmann, PhD - Scientist, Bristol-Myers Squibb

The Cedex Bio HT Analyzer and Sm@rtline Data Cockpit (SDC) middleware integrate seamlessly to offer comprehensive process analytics and innovative data management capabilities.  This combination delivers the analysis speed, data quality, and reduced hands on time needed to support high throughput applications. 

This luncheon session will demonstrate the sophisticated analytics of the Cedex Bio HT Analyzer and the advanced capabilities of SDC middleware and will include new data presented by Matthew Rehmann, Ph. D., Scientist, Process Development-Upstream, Bristol-Myers Squibb.

CEDEX is a trademark of Roche.  Other brands or product names are trademarks of their respective holders. For use in quality control/manufacturing process only

 

12:20pm - 1:25pm 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

12:20pm - 12:50pm 30 mins
3M Presents: Women in BioProcess Luncheon Event
Meet Mentor/Mentee and Social Time
12:50pm - 1:25pm 35 mins
Info
3M Presents: Women in BioProcess Luncheon Event
Lunch and Q&A session focused on pivotal career moment and key learning
  • Moderator Jennifer Pollard, MSc. - Senior Principal Scientist, Merck & Co., Inc.
  • Panelist Karen Albertson - Global Business Director, Merck
  • Panelist Sanchayita Ghose, Ph.D. - Director, Downstream Process Development, Biologics Process Development, Bristol-Myers Squibb Company
  • Panelist Hong Li, PhD - Director, Merck
  • Panelist Jean Bender, PhD - VP, Merck
  • Panelist Sigma Mostafa, PhD - Vice President, Upstream & Downstream Process Development, KBI Biopharma
  • Panelist Maria Cho, MSc - Sr. Director, Fujifilm Diosynth

3M Separation and Purification Sciences Division (SPSD) with IBC/Knect Life Sciences are initiating a new event: a professional roundtable forum for women scientists to share their work experiences with leaders, like you, in the bioprocessing industry. Participants will network with pioneers in the field, learn about bioprocess career trajectories, and create personal connections with women scientists and executives in a variety of companies. At the event, panelists will be answering moderated questions from our audience members registered for the event on the topic of pivotal career experiences and other key learnings for women in the industry.

1:25pm - 1:30pm 5 mins
Cell Culture & Upstream Processing
Chairperson's Remarks
  • Susan Jones, PhD - Vice President and Principal Consultant, BioProcess Technology Consultants
1:25pm - 1:30pm 5 mins
Speed from Gene to Market
Chairperson's Remarks
  • Susan Jones, PhD - Vice President and Principal Consultant, BioProcess Technology Consultants
1:25pm - 1:30pm 5 mins
Recovery & Purification
Chairperson's Remarks
  • John Moscariello - Senior Director of Viral Vector and Gene Editing Process Development, Juno Therapeutics, Inc
1:25pm - 1:30pm 5 mins
Manufacturing Strategy
Chairperson's Remarks
  • Miriam Monge - Director of Marketing Integrated Solutions, Sartorius Stedim Biotech
1:25pm - 1:30pm 5 mins
Drug Product, Fill-Finish & Formulations
Chairperson's Remarks
  • Ganapathy Gopalrathnam - Senior Research Scientist, Eli Lilly & Company
1:25pm - 1:30pm 5 mins
Analytical & Quality
Chairperson's Remarks
  • Bo Yan, PhD - Senior Scientist I, AbbVie Bioresearch Center
1:25pm - 1:50pm 25 mins
Info
3M Presents: Women in BioProcess Luncheon Event
Lunch and Q&A session focused on pivotal career moment and key learning
  • Moderator Jennifer Pollard, MSc. - Senior Principal Scientist, Merck & Co., Inc.
  • Panelist Karen Albertson - Global Business Director, Merck
  • Panelist Sanchayita Ghose, Ph.D. - Director, Downstream Process Development, Biologics Process Development, Bristol-Myers Squibb Company
  • Panelist Hong Li, PhD - Director, Merck
  • Panelist Jean Bender, PhD - VP, Merck
  • Panelist Sigma Mostafa, PhD - Vice President, Upstream & Downstream Process Development, KBI Biopharma
  • Panelist Maria Cho, MSc - Sr. Director, Fujifilm Diosynth

3M Separation and Purification Sciences Division (SPSD) with IBC/Knect Life Sciences are initiating a new event: a professional roundtable forum for women scientists to share their work experiences with leaders, like you, in the bioprocessing industry. Participants will network with pioneers in the field, learn about bioprocess career trajectories, and create personal connections with women scientists and executives in a variety of companies. At the event, panelists will be answering moderated questions from our audience members registered for the event on the topic of pivotal career experiences and other key learnings for women in the industry.

1:25pm - 2:45pm 80 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

1:30pm - 2:00pm 30 mins
Cell Culture & Upstream Processing
Speeding Up Cell Line Development – Implementing Novel Technologies to Reduce Timelines
  • Thomas Jostock, PhD - Science and Technology Lead, Novartis Pharma AG
1:30pm - 2:00pm 30 mins
Speed from Gene to Market
Speeding Up Cell Line Development – Implementing Novel Technologies to Reduce Timelines
  • Thomas Jostock, PhD - Science and Technology Lead, Novartis Pharma AG
1:30pm - 2:00pm 30 mins
Recovery & Purification
Scalable Purification Platform Development from the Cell-Free Expression System for Site-Specific Antibody Drug Conjugates
  • Julie Hang, PhD - Associate Director, Sutro Biopharma
1:30pm - 2:00pm 30 mins
Info
Manufacturing Strategy
Capacity Planning for a Growing Specialty Care Portfolio
  • Joseph Neal, MSc, MBA - Manager, Biologics Operations Strategy, AstraZeneca

AstraZeneca has experienced tremendous growth in its Biologics portfolio with three new specialty care medicines launched in 2017 and more launches expected in the future. The specialty portfolio demands industry leading customer service for large unmet patient need and high demand variability. To meet this challenge, the end to end supply chain needs to be an integrated and interdependent network delivering reliable and agile supply at the right cost. This discussion will highlight an approach to managing long term capacity planning across highly variable NPI programs, integration of demand signals across the organization, and timely capacity sanctions to ensure a Supply Network capable of delivering critical medicines to patients.

1:30pm - 2:00pm 30 mins
Info
Drug Product, Fill-Finish & Formulations
Subcutaneous Injection Physiology Research to Improve Biologics Delivery and the Patient Experience
  • Michael Harrison, PhD - Director, Delivery and Device Innovation, Eli Lilly

Understanding subcutaneous tissue physiology and injection biomechanics will better inform formulation and delivery system design to minimize pain and improve tolerability of subcutaneous injections. This presentation will discuss advances in understanding pain and tolerability of subcutaneous injections and review work we are doing to build upon this knowledge to optimize product design.

1:30pm - 2:00pm 30 mins
Info
Analytical & Quality
Applying LC-MS Multi-Attribute Method (MAM) to Accelerate Biopharmaceutical Development and Release
  • Li Zang, PhD - Associate Director, Analytical Development, Biogen

The multi-attribute method (MAM) based on LC-MS peptide mapping has demonstrated its capability in quantitating post-translational modifications (PTMs) and detecting sequence variants, as well as other impurities, such as host-cell proteins in protein biopharmaceuticals. The quantitative information of PTMs from MAM such as oxidation, deamidation, isomerization, clipping as well as N-glycosylation are potentially directly linked to the purity, impurity, N-glycan and charge heterogeneity profiles of the biopharmaceuticals. Some of the PTMs are correlated with the biological functions of the biopharmaceuticals. For example, levels of Fc methionine oxidation, afucosylation are correlated with the mAb Fc effector functions. High mannose glycan level on mAb Fc not only affects Fc effector function but also reflects the PK clearance of mAb. The capability of MAM to report quantitative information of these PTMs offers an opportunity to replace multiple conventional biochemical and bioassay tests using the MAM in protein pharmaceutical development and manufacturing.  Software packages that perform automatic processing and storage in a database format of MAM data can be powerful tools to manage the knowledge gathered during the lifetime of a biopharmaceutical from clone screening, process development and characterization to commercial manufacturing and release. Examples of MAM used for mAb clone screening and process development as well as potential replacement of selected release assays using MAM for a mAb will be demonstrated in the talk.

1:30pm - 2:00pm 30 mins
Info
Novel Technology Showcase: Single- Use Technologies
The Cell Harvesting Guide: Evaluating the right harvesting technology from a cost/performance perspective
  • Silke Bergheim-Pietza, MSc - Global Product Manager, Pall Biotech
2:00pm - 2:30pm 30 mins
Cell Culture & Upstream Processing
PANEL DISCUSSION – Strategies for Increasing Use of Pool Clones for Tox and Clinical Material
  • Dot Reilly - Principal Scientist/Associate Director, Genentech, Inc; USA
  • Subinay Genguly, PhD - Associate Director, CMC Team Lead, Centocor Research & Development, Inc.
  • Thomas Jostock, PhD - Science and Technology Lead, Novartis Pharma AG
  • Amy Shen, PhD - Principal Scientist, Genentech Inc.
2:00pm - 2:30pm 30 mins
Speed from Gene to Market
PANEL DISCUSSION – Strategies for Increasing Use of Pool Clones for Tox and Clinical Material
  • Dot Reilly - Principal Scientist/Associate Director, Genentech, Inc; USA
  • Subinay Genguly, PhD - Associate Director, CMC Team Lead, Centocor Research & Development, Inc.
  • Thomas Jostock, PhD - Science and Technology Lead, Novartis Pharma AG
  • Amy Shen, PhD - Principal Scientist, Genentech Inc.
2:00pm - 2:30pm 30 mins
Recovery & Purification
Development of a Scalable Manufacturing Process for the Purification of Exosomes
  • Kimberly Ellis, MSE - Senior Research Associate, Codiak Biosciences
2:00pm - 2:30pm 30 mins
Info
Manufacturing Strategy
Implementation of BPOG’s Biomanufacturing Technology Roadmap: Progress, Challenges and Prospects
  • Rajesh Beri, Ph.D. - Technical Director Research & Technology, BioManufacturing, Lonza

Over 30 organizations representing Biomanufacturers, Technology suppliers and Academic institutions participated in developing a first of its kind Technology Roadmap for Biologics Manufacturing. The BPOG TRM published in July 2017 has generated considerable interest within the Industry. Over 100 critical needs were identified by the six Roadmap sub teams to achieve the 10-year vision of lower Cost of Goods, increased quality and speed and increasing diversity of facility design. 12 key projects addressing the respective critical needs were initiated in October 2017 by the participating organizations. At the conclusion of year 1, the progress made as well as retrospective inspection of the Tech Roadmap effort and future prospects will be reviewed during this presentation.

2:00pm - 2:30pm 30 mins
Info
Drug Product, Fill-Finish & Formulations
The Interplay between User Requirements, Target Product Profile and Delivery Device Design Inputs
  • Jeffrey Givand, PhD - Director, Device Development, Merck, Sharp & Dohme

Development of high concentration biologic parenteral formulations presents unique challenges to formulation and device development scientists. Employing user-focused research to understand the use environment and capabilities enables clearer definition of product requirements. With this knowledge, development teams are then able to determine the most optimal approach to address these requirements.

2:00pm - 2:30pm 30 mins
Info
Analytical & Quality
Determination of Proteins Detected by Host Cell Protein ELISA Assays using Mass Spectrometry
  • Martha Staples, PhD - Principal Scientist, Sanofi

Mass spectrometry is typically used as an orthogonal HCP characterization technique while an ELISA method is used as the release assay. Sometimes, ELISA assays have been shown to be insensitive to relatively abundant HCPs. In this study, the antigens used to raise ELISA antibodies were analyzed to measure amounts of HCPs and then the antibodies were used to purify HCPs from products to better understand ELISA assay results.

2:00pm - 2:30pm 30 mins
Info
Novel Technology Showcase: Single- Use Technologies
Allegro™ STR Single-use Bioreactors
  • Ing-Kae Wang, PhD - Sr. Principal Scientist, Pall Biotech

Several key design parameters were characterized for different sized single-use bioreactors within Pall Allegro™ family of single-use bioreactors. Maintaining equivalent power per unit volume as the primary scaling parameter, data from CHO cells cultured in these bioreactors demonstrate cell culture scalability across the entire Allegro™ Single-use bioreactor platform.

2:30pm - 2:45pm 15 mins
Cell Culture & Upstream Processing
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Speed from Gene to Market
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Recovery & Purification
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Manufacturing Strategy
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Drug Product, Fill-Finish & Formulations
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Analytical & Quality
Short Refreshment Break
2:30pm - 2:45pm 15 mins
Novel Technology Showcase: Single- Use Technologies
Short Refreshment Break
2:45pm - 3:30pm 45 mins
Keynote Presentations
High-Impact Ideas and Use-Inspired Research - A Chat with MIT's Bob Langer on How to Create Innovations That Matter
  • Robert Langer, ScD - David H. Koch Institute Professor, Massachusetts Institute of Technology
2:45pm - 5:00pm 135 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

3:30pm - 4:15pm 45 mins
Keynote Presentations
Driving Value with Process and Facility Intensification: Moving from Current- to Next- Generation Bioprocessing
  • E. Morrey Atkinson, PhD - VP/Head of Internal Commercial Manufacturing, Biologics, Bristol-Myers Squibb
4:15pm - 5:00pm 45 mins
Keynote Presentations
The Complex World of Biosimilar Process Development
  • Elsie DeBella, PhD - Vice President, Biologics Process and CMC Development, Momenta Pharmaceuticals
5:00pm - 7:00pm 120 mins
Info
Grand Opening of the Poster & Exhibit Hall and Cocktail Reception

Connect with thousands of like-minded attendees, speakers, sponsors and exhibitors during the grand opening of our exhibit hall.  Enjoy a decadent display of hors d'oeuvres and grab a glass of wine/beer as our exhibitors showcase today's latest technologies in bioprocessing.

Access to this event is included with all conference registrations.