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Mar 12
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7:00am - 8:00am

Registration and Morning Coffee

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Showing of Streams
9:15am - 9:55am

Networking Refreshment Break and Grand Opening of the Exhibit & Poster Hall

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Showing of Streams
Showing of Streams
Showing of Streams
Showing of Streams
3:20pm - 4:00pm

Networking Refreshment Break in Exhibit & Poster Hall

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Showing of Streams
5:30pm - 6:45pm

Cocktail Reception in Exhibit & Poster Hall

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7:00am - 8:00am 60 mins
Registration and Morning Coffee
8:00am - 8:05am 5 mins
Plenary Session
Conference Opening & Welcome
8:05am - 9:15am 70 mins
Plenary Session
Knowledge and Technology Management to Launch and Lifecycle Management
  • Jerry Murry, PhD - Vice President, Amgen
9:15am - 9:55am 40 mins
Networking Refreshment Break and Grand Opening of the Exhibit & Poster Hall
9:55am - 10:00am 5 mins
Flexible & Smart Facilities
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Early Stage Process Development
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Late Stage Process Development
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
Commercial Manufacturing & Beyond
Chairperson’s Opening Remarks
9:55am - 10:00am 5 mins
New! Viral Safety
Chairperson’s Opening Remarks
9:55am - 11:30am 95 mins
Info
Novel Technologies
Experts Roundtable: Beyond Bioprocessing 4.0: Enabling Technologies, Analytics, & Leveraging the new Digital Era

This panel discussion will focus on case studies and perspectives from industry experts on the implementation of Bioprocessing 4.0 today, remaining gaps and barriers to overcome while addressing the following topics:

  • Enabling technologies for process intensification
  • Advanced analytical technologies
  • Software and automation for smart facilities

Panelists:

  • Jeet Sarkar, Senior Director Manufacturing IT, Shire
  • Michael Phillips, Head of Next Generation Processing Applications & Innovation, MilliporeSigma
  • Nuno Pinto, Bioprocess Development, Merck & Co Inc.
  • End-user panelist 3 (soon to be announced)

Moderator:

Merrilee Whitney, Head of BioContinuum™ Platform for Next Generation Bioprocessing, MilliporeSigma

10:00am - 10:30am 30 mins
Flexible & Smart Facilities
Next Generation Biomanufacturing and Facility Implementation: Technical Advances in Manufacturing Technologies to Improve Process Productivity
  • Parrish Galliher - CTO Upstream and Founder, Xcellerex Inc., GE Healthcare Life Sciences
10:00am - 10:30am 30 mins
Early Stage Process Development
Keynote Address - Technology and Innovation for Commercial Manufacturing: Living at the Interface of Development and Manufacturing
  • Paul Wu - Head of Upstream Development, Bayer U.S. LLC
10:00am - 10:30am 30 mins
Late Stage Process Development
Keynote Address - Technology and Innovation for Commercial Manufacturing: Living at the Interface of Development and Manufacturing
  • Paul Wu - Head of Upstream Development, Bayer U.S. LLC
10:00am - 10:30am 30 mins
Commercial Manufacturing & Beyond
Next Generation Biomanufacturing and Facility Implementation: Technical Advances in Manufacturing Technologies to Improve Process Productivity
  • Parrish Galliher - CTO Upstream and Founder, Xcellerex Inc., GE Healthcare Life Sciences
10:00am - 10:30am 30 mins
New! Viral Safety
A novel dual orthogonal virus inactivation in a single unit operation in antibody production
  • June Zou - Process Scientist, Bayer Healthcare LLC
10:30am - 11:00am 30 mins
Flexible & Smart Facilities
Improvements in Facility Design and Readiness for Diversity of Products
  • Ken Hamilton - Senior Principle Engineer, Genentech
10:30am - 11:00am 30 mins
Info
Early Stage Process Development
Anticipating Late-stage Needs in Early-stage Development
  • Aaron Chen - Principal Scientist, Seattle Genetics

Drug companies and regulatory agencies are under tremendous pressure to shorten the time for bringing drugs to market for unmet medical needs. The platform process approach, a popular early-stage development strategy for speeding up regulatory submissions, attempts to minimize resource commitment and shorten development timelines. However, the platform process is not molecule-specific and can be sub-optimal. Also, this approach defers a significant workload to late-stage development where a detailed understanding of product-specific process knowledge is required to ensure a robust process. In the area of upstream process development, it is especially challenging to maintain consistent critical quality attributes when changes such as cell line, process and scale are necessary to fulfill commercial requirements. Additionally, typical bench-top small-scale models may be insufficient to execute large and complex multivariate experiments, which are needed to gain molecule-specific knowledge. This presentation discusses a development strategy that minimizes changes as programs progress through development stages and allows flexibility for potential acceleration of timelines.

10:30am - 11:00am 30 mins
Info
Late Stage Process Development
Anticipating Late-stage Needs in Early-stage Development
  • Aaron Chen - Principal Scientist, Seattle Genetics

Drug companies and regulatory agencies are under tremendous pressure to shorten the time for bringing drugs to market for unmet medical needs. The platform process approach, a popular early-stage development strategy for speeding up regulatory submissions, attempts to minimize resource commitment and shorten development timelines. However, the platform process is not molecule-specific and can be sub-optimal. Also, this approach defers a significant workload to late-stage development where a detailed understanding of product-specific process knowledge is required to ensure a robust process. In the area of upstream process development, it is especially challenging to maintain consistent critical quality attributes when changes such as cell line, process and scale are necessary to fulfill commercial requirements. Additionally, typical bench-top small-scale models may be insufficient to execute large and complex multivariate experiments, which are needed to gain molecule-specific knowledge. This presentation discusses a development strategy that minimizes changes as programs progress through development stages and allows flexibility for potential acceleration of timelines.

10:30am - 11:00am 30 mins
Commercial Manufacturing & Beyond
Improvements in Facility Design and Readiness for Diversity of Products
  • Ken Hamilton - Senior Principle Engineer, Genentech
10:30am - 11:00am 30 mins
New! Viral Safety
Effective inactivation of a wide range of viruses by pasteurisation
  • Birgit Popp - Director Virus Safety Development, CSL Behring
11:00am - 11:30am 30 mins
Flexible & Smart Facilities
Transformation of CAR-T Manufacturing Through Use of Closed-Processing, Process Automation and Strategic Raw Material Configuration
  • Randy Schweickart, MS - Director of Engineering, Juno Therapeutics, Inc
11:00am - 11:30am 30 mins
Early Stage Process Development
Developing Phase 1 Process with Line of Sight to Commercial
  • Sigma Mostafa, PhD - Vice President, Upstream & Downstream Process Development, KBI Biopharma
11:00am - 11:30am 30 mins
Late Stage Process Development
Developing Phase 1 Process with Line of Sight to Commercial
  • Sigma Mostafa, PhD - Vice President, Upstream & Downstream Process Development, KBI Biopharma
11:00am - 11:30am 30 mins
Commercial Manufacturing & Beyond
Transformation of CAR-T Manufacturing Through Use of Closed-Processing, Process Automation and Strategic Raw Material Configuration
  • Randy Schweickart, MS - Director of Engineering, Juno Therapeutics, Inc
11:00am - 11:30am 30 mins
New! Viral Safety
Virus barrier filtration – Eli Lilly Case Study
  • Sean O'Donnell - Principal Research Scientist, Eli Lilly & Co
11:30am - 12:00pm 30 mins
Info
Flexible & Smart Facilities
THOUGHT LEADERS DISCUSSION: Multiproduct Facilities Review – Evaluating Costs of Goods and Practicalities of Implementation
  • Adam Goldstein - Principal Scientist, Roche
  • Gene Yoshioka - Sr. Director of Manufacturing, Avid Bioservices
  •  Multiproduct facilities 5 years + on – What are the realities of implementing? 

  • Evaluating the cost of goods for multiproduct facilities and cost saving initiatives 

  • Strategies to implement high flexibility and fast product turnovers  

  • Strategies for cleaning and cleaning validation that minimise downtime for product changeovers 

  • Applicability of multiproduct plants for low volume products

11:30am - 12:00pm 30 mins
Early Stage Process Development
Panel Discussion: Can We Achieve Single-Phase Process Development?  What will it Take?
  • Nikki Nogal, PhD - Senior Consultant, Biologics Product Development Specialist, Latham BioPharm Group
11:30am - 12:00pm 30 mins
Late Stage Process Development
Panel Discussion: Can We Achieve Single-Phase Process Development?  What will it Take?
  • Nikki Nogal, PhD - Senior Consultant, Biologics Product Development Specialist, Latham BioPharm Group
11:30am - 12:00pm 30 mins
Info
Commercial Manufacturing & Beyond
THOUGHT LEADERS DISCUSSION: Multiproduct Facilities Review – Evaluating Costs of Goods and Practicalities of Implementation
  • Adam Goldstein - Principal Scientist, Roche
  • Gene Yoshioka - Sr. Director of Manufacturing, Avid Bioservices
  •  Multiproduct facilities 5 years + on – What are the realities of implementing? 

  • Evaluating the cost of goods for multiproduct facilities and cost saving initiatives 

  • Strategies to implement high flexibility and fast product turnovers  

  • Strategies for cleaning and cleaning validation that minimise downtime for product changeovers 

  • Applicability of multiproduct plants for low volume products

11:30am - 12:00pm 30 mins
New! Viral Safety
Please move to another track
12:00pm - 12:30pm 30 mins
Info
Technology Workshops
Chromassette®, a 3D printed modular chromatography platform enabling next-generation, hyper-productive bioprocess purification
  • Masayoshi Nagaya - Sr. Global Technology Manager, JSR Life Sciences

A stackable, pre-packed chromatography cassette with a supported bed, Chromassette® is a novel product concept in downstream processing that addresses the current key challenges in manufacturing and scale-up.  Chromassette enhances the purification process capabilities of chromatography resins and combines it with the convenience of a pre-packed, modular cassette.  A range of application examples and case studies will be presented.

12:00pm - 12:30pm 30 mins
Info
Technology Workshop 2
Single-Use Polymers and Performance
  • Janelle Rupkalvis - Field Applications Engineer, Entegris

In this presentation, Janelle Rupkalvis will discuss the unique characteristics that polymers bring to single-use bioprocessing applications.  Included will be material performance data demonstrating toughness, purity, chemical resistance and temperature capabilities of several single-use polymers along with guidelines on how to use this information to properly select a material for your application.

12:00pm - 12:30pm 30 mins
Info
Technology Workshop 3
High-Throughput Development of Perfusion Processes and Implementation of Scalable and Flexible Intensified Manufacturing Strategies
  • Melisa Carpio - Global Technology Consultant, Sartorius Stedim

Fed-batch and perfusion cultures are the two most common modes of operation for mammalian cell culture production.  Even within those modes, there are many options like traditional fed-batch, intensified fed-batch, and continuous or semi-continuous perfusion processes.  The flexibility of the ambr 250 allows for the production mode to be included as part of the process development process to determine which is optimal for a specific cell line.  It allows for both fed-batch and perfusion to be run in parallel using an automated, small-scale bioreactor system.  Once the optimal process has been determined, using various combinations of rocking motion and stirred tank bioreactors allows for truly flexible, single-use manufacturing using only four upstream unit operations – RM 50, RM 200, STR 500, and STR 2000.  This presentation will focus on case studies that highlight the end-to-end scalability and flexibility of upstream process development to commercial manufacturing using the ambr 250 and BIOSTAT RM/STR.

12:00pm - 12:30pm 30 mins
Info
Technology Workshop 4
Technology Workshop
12:30pm - 1:30pm 60 mins
Info
Luncheon Presentation 1
Luncheon: Using Peptones to Achieve Diverse and Demanding Bioproduction Goals
  • Stacy Holdread - Staff Scientist, BD Biosciences Advanced Bioprocessing

As bioproduction requirements advance, it is critical to have consistent, high-quality media and supplements to meet industry needs. Peptones have been successfully used in bioproduction applications for more than 30 years. Their unique nutritional profiles and usage flexibility make them ideal components for creating a robust bioprocess. This session demonstrates the benefits of peptones and how they can enhance process performance.

12:30pm - 1:30pm 60 mins
Info
Luncheon Presentation 2
Luncheon Presentation: Sartorius
  • Speaker 1 Roberto Menzel, PhD - Laboratory Manager, Sartorius Stedim Biotech
  • Speaker 2 Klaus Wormuth - Lead Scientist Particles, Sartorius Stedim Biotech

Part 1: 

Extractables Data from Single-Use Systems for the Biopharmaceutical Industry - Need Extractables be such a difficult and “controversial” topic?

Single-use technology is without question one of the key technologies enabling rapid development of the biopharmaceutical industry and the manufacturing of drug products. However, despite tremendous advantages compared to stainless steel equipment, especially for scalable application such as the production of vaccines, CAR T cells, or monoclonal antibodies (mAb) or the manufacturing of biosimilars, single-use system (SUS) adoption lags behind its potential.1–3 One of the main concerns over the last decades continues to be extractables from SUS which might end up as leachables in the process stream. This presentation will focus on what we know, where we stand and what are the main challenges we face in the future. Key points are: Consistency of extractables study results or extractables data for full assemblies and how to calculate and model them. This presentation will also provide insight as to why it is sometimes rather beneficial to provide extractables data to our partners in the biopharmaceutical industry which are derived from a simple solvent system but with a reliable identification.

1.         Demarque, D. P., Crotti, A. E. M., Vessecchi, R., Lopes, J. L. C. & Lopes, N. P. Fragmentation reactions using electrospray ionization mass spectrometry: an important tool for the structural elucidation and characterization of synthetic and natural products. Nat. Prod. Rep. 33, 432–455 (2016).

2.         Gao, Y. & Allison, N. Extractables and leachables issues with the application of single use technology in the biopharmaceutical industry. J. Chem. Technol. Biotechnol. 91, 289–295 (2016).

3.         Mirasol, F. Industry Adoption of Single-Use Systems Remains Low. BioPharm Int. 31, 33–35 (2018).


Part 2: 

Reduction and control of risks to biopharmaceuticals from particulate matter in single-use systems

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. In particular, data from our newly developed “Visual Particle Test” (VPT) allow determination of process capability and point to paths for continuous improvement.


1:40pm - 1:45pm 5 mins
Flexible & Smart Facilities
Chairperson’s Opening Remarks
1:40pm - 1:45pm 5 mins
Early Stage Process Development
Chairperson’s Opening Remarks
1:40pm - 1:45pm 5 mins
Late Stage Process Development
Chairperson’s Opening Remarks
1:40pm - 1:45pm 5 mins
Commercial Manufacturing & Beyond
Chairperson’s Opening Remarks
1:40pm - 1:45pm 5 mins
New! Viral Safety
Chairperson’s Opening Remarks
1:40pm - 2:45pm 65 mins
Novel Technologies
Chairperson’s Opening Remarks
1:45pm - 2:15pm 30 mins
Info
Flexible & Smart Facilities
Modular Platform Delivery Considerations for Today’s New Drug Production Facilities: Case Studies from Recent Design Competitions
  • Peter Cramer - Vice President Life Science Facility Design, Exyte U.S., Inc

Modular Facility Design and standardization initiatives continues to be at the forefront of new construction techniques aimed at reducing cost and schedule while keeping quality high.  This presentation will cover four (4) recent case studies of facility prototypes that leverage new ways of integrating modular systems to their fullest.  Prototype designs include: 

  • Single Use Biotech / Drug Substance 

  • Cell & Gene Therapy 

  • Fill Finish / Drug Product 

  • Antibody Drug Conjugate 

Biopharma wants to make new drug products more accessible and at the same time be able to quickly respond to changes in the way new drugs are produced and the variations in product demand.  The industry is challenged to deliver truly flexible biopharmaceutical manufacturing facilities with significant reductions in schedule, cost, and client operating resources. 

To achieve these goals, design firms in the Life Sciences market are now capturing many of their best practices for flexible manufacturing into a prototype facility design where modular and other pre-engineered systems can be evaluated for use on a project.  The platform-modular approach along with a set of analysis tools allows life science companies to rapidly ascertain the economic advantage of using a prototype design and the degree to which modular and pre-engineered systems can be leverage to reduce cost and schedule while retaining the overall quality they need.  

This presentation will show recent modular prototype designed and the platform design approach that was used to create them.  These prototypes demonstrate how companies can leverage the best systems the modular market now has to offer.  

1:45pm - 2:15pm 30 mins
Info
Early Stage Process Development
Speed to IND: are stable pools or transient gene expression viable manufacturing options?
  • Yves Durocher, PhD - Section Head, Mammalian Cell Expression - NRC Human Health Therapeutics Research Center, National Research Council Canada

Chinese Hamster Ovary (CHO) cells are a workhorse expression host for production of protein-based biotherapeutics. Expression from stably transfected CHO clones is just one means of recombinant protein production in CHO cells, but lower productivity and longstanding regulatory guidelines have restricted the use of alternative approaches, such as non-clonal stable pools and transient gene expression (TGE), for drug manufacturing. Recently, the performance of stable pool and TGE methods has improved dramatically, making them viable options for producing drug substance for GLP-toxicology, early-phase clinical trials, and other scenarios that demand rapid production timelines. We propose that regulatory guidelines be updated to permit these alternative expression modes as they may enable more rapid and cost-effective clinical evaluation of potentially life-saving drugs.

1:45pm - 2:15pm 30 mins
Late Stage Process Development
Registration Enabling Campaign for Accelerated Development
  • Jessica Wuu, PhD - Senior Engineer, Late Stage Cell Culture, Genentech
1:45pm - 2:15pm 30 mins
Commercial Manufacturing & Beyond
How to Shorten Launch Timelines for New Products
  • Jody Logan - Associate Director of Tech Transfer, Genentech, USA
1:45pm - 2:15pm 30 mins
New! Viral Safety
Novel Approach to Achieve Complete Retention of Viruses Using Regenerated Cellulose Viral Filters
  • Wensheng Wang, PhD - Senior Staff Development Scientist, Bayer HealthCare
2:15pm - 2:45pm 30 mins
Info
Flexible & Smart Facilities
Plug and Play Automation for Single Use Equipment
  • Eugene Tung - Executive Director of Manufacturing IT,, Merck MSD

The industry’s movement away from large scale, fixed tank facilities to more flexible, single use technologies has demonstrated the desire to move toward flexibility in process equipment.  This has created an equivalent need to move towards more flexible automation systems as well.  The need to quickly and easily build and change process systems is leading to the need for new automation designs that enable the ability to build facilities and change the unit operations inside without the need for large scale development efforts to do so. 

The benefits of flexible, standardized automation designs: 

-   Significantly reduce build times for new facilities (allowing for decisions to build to be placed much later in the product approval cycle) 

-   Significantly reduce development costs by reducing development efforts and making them more of a configuration effort 

-   Significantly reduce the time and cost of change existing facilities 

-   Lower life cycle costs by spreading the cost of maintenance across all users of the standard 

-   Increase flexibility 

-   Increase innovation by reducing barriers to introduction of new technologies 

The presentation describes the implementation of a standard interface that allows a supervisory control system to interface to a process skid.  The standardized interface has been developed for three common unit operations:  a bioreactor, a filtration skid, a chromatography column.  The goal will be to have the supervisory system be able to pass control signals down and collect data up from the unit operations with a minimum of programming effort and to be able to do so independent of controller manufacturer.  A proof-of-concept software demonstration utilizing actual equipment from DCS vendors and equipment suppliers shows the viability of this concept. 

2:15pm - 2:45pm 30 mins
Info
Early Stage Process Development
Case Study: Biologics CMO Overview - A Balance between Quality, Speed and Cost
  • Qinghai Zhao - VP of Technical Development and Manufacturing, FortySeven Inc
  • Overview of biologics CMOs for protein therapeutics
  • How to select a CMO for speed to IND
  • Balance between quality, speed and cost
  • Keep accelerated option of commercialization in mind
  • Integrated CMO service for early stage CMC development
  • One-stop shop case study
2:15pm - 2:45pm 30 mins
Late Stage Process Development
High Speed Late Stage Development to Support Accelerated Launch of Product
2:15pm - 2:45pm 30 mins
Commercial Manufacturing & Beyond
Managing Life Cycle of a Break Through Therapy Designated Product
  • Nguyen Ly - Director, Merck & Co.
2:15pm - 2:45pm 30 mins
Info
New! Viral Safety
Evaluation of the HAV and HEV Clearance Capacity Provided by Nanofiltration in the GAMUNEX®-C Manufacturing Process
  • Barry Gooch - Associate Director, Grifols

The manufacture of GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified) includes production segments that confer to the product a wide margin of safety against the risk of virus transmission, e.g., caprylate treatment, nanofiltration and low pH incubation.

In recent years, we have carried out virus safety evaluations of the GAMUNEX-C process’ nanofilter, which has a mean pore size of 35 nanometers. Test viruses were intentionally spiked into the GAMUNEX-C matrix that was subsequently nanofiltered in a manner comparable to the commercial-manufacturing segment. As expected, the nanofilter imparts a robust capacity to remove viruses larger than 35 nm in diameter. But less intuitive results were obtained for hepatitis A and E viruses; both were retained by the nanofilter to the extent that no residual infectivity could be detected in the filtrate.

Based solely on the virus’ diameters reported by the International Committee on Taxonomy of Viruses (ICTV), 30-32 nm for HAV and 27-34 nm for HEV, we had not anticipated either to be substantially retained. We hypothesized that their retention was facilitated by one or more components of the GAMUNEX-C matrix.

In this presentation we demonstrate that IgG is not essential for removal of HAV and HEV by the GAMUNEX-C process’ nanofilter. Rather, retention of HAV is dependent on glycine, which is an excipient in the formulation, and is facilitated by low pH; whereas, retention of HEV is independent of glycine and low pH at nominal process conditions, suggesting that its diameter is larger, on

2:45pm - 3:20pm 35 mins
Info
Flexible & Smart Facilities
Enabling efficient biomanufacturing with digital innovation
  • Harlan Knapp - Business Development Manager, GE Healthcare Life Sciences

Constant pressures to improve productivity have led biomanufacturers to carefully examine potential benefits of Industry 4.0 and cloud-enabled data lakes. We will explore the concept of a factory that uses a combination of lean and digital manufacturing to enhance efficiency. See how digital solutions such as Lab Cloud, Digital Twin, and Asset Performance Management are deployed to enable the next generation of drug development and flexible manufacturing.

2:45pm - 3:20pm 35 mins
Info
Early Stage Process Development
Early Stage
2:45pm - 3:20pm 35 mins
Info
Late Stage Process Development
Integrated Data Management from Research to GMP Production in Pharma Biotech
  • Tim Noetzel, PhD - Manager, Roche Diagnostics GmbH

Integrated data collection has been established from simple to complex analyzers within pharma bioprocesses including pH meters, Cedex Analyzers, microscale bioreactors, particle counters, or mass spectrometry. These data feed into (meta)data integration layers to enable deep learning and agile process development. The talk describes how Roche Pharma Penzberg, Singapore and Basel use Sm@rtLine Data Cockpit middleware to support this approach.

2:45pm - 3:20pm 35 mins
Info
Commercial Manufacturing & Beyond
Commercial Manufacturing & Beyond
2:45pm - 3:20pm 35 mins
Info
New! Viral Safety
Key Requirements for Virus Filters in Clinical and Commercial Virus Filtration Process Development
  • Brian Buesing - Senior Research Associate, AsahiKASEI

Different stages of biopharmaceutical process development, from pre-clinical to commercial manufacturing, carry different demands and requirements for the virus filter. In this presentation, we will explore key characteristics of virus filters and consider the relationship between filter characteristics and the development of commercial virus filtration processes using customer case studies for Planova™ BioEX.

3:20pm - 4:00pm 40 mins
Networking Refreshment Break in Exhibit & Poster Hall
4:00pm - 4:30pm 30 mins
Info
Flexible & Smart Facilities
Implementation of PAT and Digital Tools for Real-Time Process Monitoring and Quality Control
  • Becky Chan - Process Development Scientist, Amgen Inc.

Historically, cell culture development was conducted in batch. Bioreactors with varying modulating components were run simultaneously, limited by the number of available bioreactors. In-depth experimental outcome and evaluation were usually done post bioreactor run duration, pending off-line PQA and media consumption results, which may take weeks to months. The turn-around time (TAT) for these analyses significantly delay the re-design and execution of the next phase of development. The online real-time PAT tools we developed, such as online MAM, SEC, CEX, titer, and metabolite analysis, can significantly enhance cell culture development efficiency. Effect of the modulator/lever on PQA will be able to monitor daily with near-real-time feedback. Any adverse or beneficial effect can be mitigated or promoted instantly, saving time, cost, and footprint.

4:00pm - 4:30pm 30 mins
Info
Early Stage Process Development
Accelerated Timelines for Complete IND Submissions
  • Frank Ritacco, PhD - Director, Scientific and Technical Affairs, Patheon, Part of Thermo Fisher Scientific
  • New solutions that address the need for fast, FIH clinical trial material and supply
  • The difference between an IND filing and a complete IND submission
  • The key drivers for rapid IND filings such as accelerated approval pathways, heightened market competition and desire for cash preservation
4:00pm - 4:20pm 20 mins
Late Stage Process Development
Studies on Endogenous Retrovirus-like Particles in Fed Batch and Continuous Manufacturing: Morphology Quantification and Clearance
  • Shawn Liu - Chief Scientist & Head, Bayer HealthCare LLC
4:00pm - 4:30pm 30 mins
Commercial Manufacturing & Beyond
Life After Launch – Factors to Consider when Navigating Post-Approval Process Optimization
  • Nathan McKnight, Ph.D - Associate Director, Genentech
4:00pm - 4:20pm 20 mins
New! Viral Safety
Studies on Endogenous Retrovirus-like Particles in Fed Batch and Continuous Manufacturing: Morphology Quantification and Clearance
  • Shawn Liu - Chief Scientist & Head, Bayer HealthCare LLC
4:20pm - 4:40pm 20 mins
Late Stage Process Development
Viral Clearance Validation Across Continuous Capture Chromatography
  • Srinivas Chollangi, PhD - Manager, Bristol-Myers Squibb
4:20pm - 4:40pm 20 mins
New! Viral Safety
Viral Clearance Validation Across Continuous Capture Chromatography
  • Srinivas Chollangi, PhD - Manager, Bristol-Myers Squibb
4:30pm - 5:00pm 30 mins
Flexible & Smart Facilities
Data at Your Fingertips: The Benefits of an Integrated Informatics System
  • Carly Cox - Process Informatics Manager, Global Engineering, Pfizer
4:30pm - 5:00pm 30 mins
Early Stage Process Development
Panel Discussion: Strategies to Increase Speed from DNA to IND Submission
  • Panellist Frank Ritacco, PhD - Director, Scientific and Technical Affairs, Patheon, Part of Thermo Fisher Scientific
4:30pm - 5:00pm 30 mins
Commercial Manufacturing & Beyond
Data at Your Fingertips: The Benefits of an Integrated Informatics System
  • Carly Cox - Process Informatics Manager, Global Engineering, Pfizer
4:40pm - 5:00pm 20 mins
Late Stage Process Development
Viral Clearance for a Novel Approach to Continuous Viral Filtration
  • Tarl Vetter, PhD - Senior Scientist, Sanofi
4:40pm - 5:00pm 20 mins
New! Viral Safety
Viral Clearance for a Novel Approach to Continuous Viral Filtration
  • Tarl Vetter, PhD - Senior Scientist, Sanofi
5:00pm - 5:30pm 30 mins
Flexible & Smart Facilities
Update on BPOG Technology Roadmap Workstream on Knowledge Management
  • Bert Frohlich, Ph.D., - Director, Strategy and Technology Lifecycle, Manufacturing Sciences & Technology, Shire
5:00pm - 5:20pm 20 mins
Late Stage Process Development
Viral Clearance Date for Constant Flaux Virus Filtration from Continuous Integrated Downstream Process Perspective
  • Dharmesh Kanani, Ph.D. - Senior Scientist, Downstream Development & Operations, Teva Pharmaceutical Inc.
5:00pm - 5:30pm 30 mins
Commercial Manufacturing & Beyond
Update on BPOG Technology Roadmap Workstream on Knowledge Management
  • Bert Frohlich, Ph.D., - Director, Strategy and Technology Lifecycle, Manufacturing Sciences & Technology, Shire
5:00pm - 5:20pm 20 mins
New! Viral Safety
Viral Clearance Date for Constant Flaux Virus Filtration from Continuous Integrated Downstream Process Perspective
  • Dharmesh Kanani, Ph.D. - Senior Scientist, Downstream Development & Operations, Teva Pharmaceutical Inc.
5:30pm - 6:45pm 75 mins
Cocktail Reception in Exhibit & Poster Hall