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Key Sessions

Sara Radcliffe

California Life Sciences State of the Industry 2018: A look at the trends and influences driving the life sciences industry in California for 2018 and beyond

California Life Sciences Association (CLSA)

Jason Bock, PhD

Achieving Efficiency through a Comprehensive Approach to Facility, Organization and Process Design

Teva Pharmaceuticals

7:30am - 8:00am

Registration and Coffee

Showing of Streams
9:10am - 9:40am

Networking Refreshment Break

Showing of Streams
Showing of Streams
12:15pm - 1:25pm

Networking Lunch & Technology Workshops available for Sponsorship

Showing of Streams
2:30pm - 2:35pm
Close of Conference - See you in 2019!

Close of Conference - See you in 2019!

7:30am - 8:00am 30 mins
Registration and Coffee
8:40am - 9:10am 30 mins
Keynote Presentations
Achieving Efficiency through a Comprehensive Approach to Facility, Organization and Process Design
  • Jason Bock, PhD - Vice President, Biologics CMC, Teva Pharmaceuticals
more
9:10am - 9:40am 30 mins
Networking Refreshment Break
9:40am - 9:45am 5 mins
Single-Use: Case Studies and Innovations
Chairperson's Remarks
9:40am - 9:45am 5 mins
Early Stage Process Development: Process Intensification
Chairperson's Remarks
9:40am - 9:45am 5 mins
Late Stage Process Development: Raw Materials
Chairperson's Remarks
9:40am - 9:45am 5 mins
Commercial Manufacturing: Quality Assurance
Chairperson's Remarks
9:45am - 10:15am 30 mins
Single-Use: Case Studies and Innovations
Large Scale Single Use Bulk Drug Substance Freeze and Thaw Platform
  • Jeffrey Johnson - Director and New Technology Lead, Global Engineering Solutions, Merck & Co., Inc.
more
9:45am - 10:15am 30 mins
Early Stage Process Development: Process Intensification
Process Development to Minimize a Light-Chain Mispaired Variant in a Bispecific Antibody
  • Ambrose Williams, PhD - Scientist, Genentech
more

Asymmetric bispecific antibodies comprised of different light and heavy chains are ideally suited for certain therapeutic mechanisms where monovalent crosslinking of targets is desired, such as immune cell recruitment to tumors. Developing these molecules as single-cell bispecific formats also brings convenience to bioprocess design, but increases the repertoire of chain-mispairing product-related variants. Minimizing these variants can be important to patient safety, but is challenging due to the similarity of these variants to the target molecule. A case study is presented of a bispecific design prone to LC-mispairing. This talk will focus on the rapid development of a downstream process through high-throughput chromatography screening coupled with mass spec analysis and molecular dynamics. The resulting strategy allows for identification and elimination of unique product related variants.

9:45am - 10:15am 30 mins
Late Stage Process Development: Raw Materials
Improved Characterization of Animal Serum for use in Cell Culture
  • Rosemary Versteegen, PhD - CEO, International Serum Industry Association
more

This presentation will provide an update on the development and implementation of the Industry wide date base for testing of bonnie serum for geographic origin based on trace element analysis. Recent studies which have led to improved, more specific specifications for determining whether serum is fetal or new born in origin will also be reviewed in detail.

9:45am - 10:15am 30 mins
Commercial Manufacturing: Quality Assurance
A contamination control and prevention program at an aging facility
  • Yuval Shimoni, PhD - Principal Engineer, Bayer Healthcare
more

An approach to enhancing and/or establishing a contamination control program will be presented. We will open with an introduction of current regulatory expectations and industry best practices. We will then describe the process of assessing current contamination control and prevention practices in a fully integrated (aging) manufacturing facility (warehouse, API (active pharmaceutical ingredient) and FP (final product) manufacturing/ fill-finish, as well as QC testing labs and environmental monitoring); emphasis will be given to risk prioritization of identified vulnerabilities. We will end with actions to minimize the risk of contamination incidences (excursions) as well as the potential for false positives while minimizing the disruptive impact of mitigating activities (e.g., preventive measures, training, cleaning and sanitization enhancements etc.) on routine commercial operations.

10:15am - 10:45am 30 mins
Single-Use: Case Studies and Innovations
Presentation Title Coming Soon - Genentech
10:15am - 10:45am 30 mins
Early Stage Process Development: Process Intensification
Lessons Learned: Progressing a CHO Expression System Fed-Batch Process from the Incubator to Bench-Scale Bioreactors
  • Robert Voyer, MASc, National Research Council of Canada
more

This presentation will depict, through case studies involving our in-house CHO inducible expression system, how we circumvented initial issues of drop in fed-batch process performances when moving the developed process from the incubator environment to bench-scale bioreactors, and achieved linear titer progression.

10:15am - 10:45am 30 mins
Late Stage Process Development: Raw Materials
Elemental Impurities in Chemically Defined Media Powders: Impact to Upstream Cell Culture Processes
  • Nicole Migliore - Scientist, Janssen R&D
more
10:15am - 10:45am 30 mins
Commercial Manufacturing: Quality Assurance
Global Particle Library for Drug Product Inspection
  • Adrian Bennis - Principal Engineer, Amgen
more
10:45am - 11:15am 30 mins
Single-Use: Case Studies and Innovations
Track Presentation Available for Sponsorship
10:45am - 11:15am 30 mins
Early Stage Process Development: Process Intensification
Utilizing the ambr 15 and ambr 250 perfusion as Tools for Small-Scale Process Intensification and Continuous Processing
  • Nathan Bandow, PhD - Postdoctoral Fellow, Continuous Manufacturing Skill Center, Sanofi
more

Key technologies in upstream cell culture like ATF and TFF have enabled the start of a shift towards process intensification/continuous processing in the seed train (N-1 perfusion) and main production culture (concentrated fed-batch or perfusion) for biopharmaceutical production processes. While these technologies are now available for large scale bioreactor operations, small-scale application is limited to traditional benchtop bioreactor scales and formats. In the last 5 years, fed-batch cell culture process development has been significantly accelerated by wide spread implementation of the ambr 15 and ambr 250 fully automated, single-use, micro and mini bioreactor systems. Examples will be presented on the utility of the ambr 15 as a perfusion mimic. In addition, a technical description and operating data will be presented for a novel ‘ambr 250 perfusion’ system which outlines the capacity and capability of this technology. As established with ambr 250 for fed-batch processes, ‘ambr 250 perfusion’ has the potential to provide the industry with a step change in perfusion process development capacity, enabling implementation of DoE based approaches for process optimization and characterization. It is envisaged that ‘ambr 250 perfusion’ can therefore facilitate and significantly accelerate an industry wide transition to upstream cell culture perfusion processes for novel biopharmaceuticals currently in early development.

10:45am - 11:15am 30 mins
Late Stage Process Development: Raw Materials
Track Presentation Available for Sponsorship
10:45am - 11:15am 30 mins
Commercial Manufacturing: Quality Assurance
Track Presentation Available for Sponsorship
11:15am - 11:45am 30 mins
Single-Use: Case Studies and Innovations
Feedback on Single-Use Manufacturing and a New Approach for Scale Transfer
  • Christophe Martin - USP Production Manager, MilliporeSigma
more

Single use production equipment are used at Merck Biodevelopment (Martillac, France) since 2011. In 2015, manufacturing capacity was increased after the creation of new suites dedicated to production with single use equipment, at 2KL scale. The aim of this presentation is to share a feedback after 2 years using these large scale single use systems. This presentation will discuss the benefits offered by these systems from an organizational/plant management perspective. We’ll also discuss a new USP scale-up strategy, and an improvement of CO2 stripping strategy.

11:15am - 11:45am 30 mins
Early Stage Process Development: High Throughput Development and Monitoring
Coupling of the Ambr 250 with Robocolumns for Upstream/Downstream Screening
  • Ashley Hesslein, PhD - Associate Director in Biological Development, Bayer Healthcare LLC
more

Upstream and downstream development groups have increased technical sophistication, efficiencies, and throughput using AMBR bioreactors and miniaturized columns. However, these technologies have often been confined to upstream or downstream workflows. Here we present a combined process flow which maximizes data at early development stages (clone selection) and late stages (Process Characterization).

Authors: Ashley Hesslein, Ryan Zolyomi, Yu-Hsi Chang, Justin Grahek, Patrick Trogdon, Yi Liu, Hendri Tjandra

11:15am - 12:15pm 60 mins
Young Scientists Awards - Presented by 3M
Chairperson's Opening Remarks
  • Andrew Tustian - Associate Director, Regeneron Pharmaceuticals & 3M Representative
more

11:30 Young Scientist Presentation #1 Roche/Genentech
Presenter to be determined

11.45 Young Scientist Presentation #2 Just Biotherapeutics
Presenter to be determined

12:00 Young Scientist Presentation #3 Bayer
Presenter to be determined

12:15 Young Scientist Presentation #4 Amgen
Presenter to be determined

12:30 Young Scientist Presentation #5 Gilead
Presenter to be determined

12:45 Award committee deliberates on the session and nominates a winner

12:55 Presentation of Young Scientist Award Winners
Andrew Tustian, Associate Director, Regeneron Pharmaceuticals & 3M Representative

1:00 Close of Session

11:15am - 11:45am 30 mins
Commercial Manufacturing: Cost-Modeling
Leveraging Process Simulation Models at Different Phases of Development and Commercialization
  • Rick Stock, PhD - Consultant, BioProcess Technology Consultants, Inc.
more

The right tools and processes are needed to ensure that biologics developers and manufacturers deliver the product to the patients in the “best” way possible. Robust simulation packages from cradle to grave of a product is one way to de-risk challenges and improve likelihood of success in the manufacturing suite. It is equally important that the production simulation models are designed to be flexible and/are updated as the product goes through the different stages of development to enable better decision making at every step with regards to how and where to manufacture the life improving and saving therapeutic. In this presentation, we explore important concepts for handling cost data generated using commercially available modeling tools to simulate the manufacturing of a “typical” monoclonal antibody product. We will illustrate several important concepts, through theoretical case studies such as optimizing suite capacity base on theoretical demand, supporting the decision to manufacture in-house versus outsourcing to a CMO and estimating the impact on scale of different manufacturing process. - - Tiffany D Rau, Ph.D. BioProcess Technology Consultants corresponding author.

11:45am - 12:15pm 30 mins
Single-Use: Case Studies and Innovations
Technology transfer and scale up of a late clinical stage biotherapeutic to a nearly completely single-use manufacturing facility (a case study)
  • Kishan Rao, MS - Associate Director Clinical Technical Services, Alexion
more
11:45am - 12:15pm 30 mins
Early Stage Process Development: High Throughput Development and Monitoring
High Throughput Tangential Flow Filtration for Formulation Robustness
  • Anthony Portolesi - Technical Development Research Associate, Genentech Inc.
more

A multi-channel, high throughput TFF system, which could surpass the limitations of the conventional, single-channel TFF system is being developed by Sartorius in collaboration with several biotech companies. Our findings show that the careful selection of system components and process parameters is crucial for the development of a TFF system suitable for use in formulation robustness studies.  


Anthony Portolesi1, Zephania Kwong Glover1, Debbie O’Connor2, William Man2, John Lazzareschi2, Judy Hsii2, John Betts3

1 Late Stage Pharmaceutical Development, Genentech Inc., 1 DNA Way, South San Francisco, CA 94080

2 Purification Development, Genentech Inc., 1 DNA Way, South San Francisco, CA 94080

3 Sartorius-Stedim Biotech Group, York Way, Royston,  Herts, SG8 5WY, UK

11:45am - 12:15pm 30 mins
Commercial Manufacturing: Cost-Modeling
Will the Cost of Manufacturing be the Death of Your New Therapy?
  • Jennifer Chain, PhD - Science Officer, Oklahoma Blood Institute
more

In the cell and gene therapy sector there is no shortage of new ideas for the development of cell mediated therapies. During the discovery and proof of concept phase, free money from the NIH, universities and foundations provide a safety net allowing laboratory base observations to be evaluated in a first in human application. After success is measured and reported, large sums of capital are invested into moving the therapy through the development pipeline with the vision of becoming the next “big drug”. Reliance on scaling the methods used in the laboratory have proven to not yield therapies that the market is prepared to embrace. To survive and flourish, our industry has to identify new pathways to accomplish the critical steps in preparation and manufacturing. Leveraging the existing infrastructure of the haematopoietic stem cell industry may be just what the doctor ordered.

12:15pm - 1:25pm 70 mins
Networking Lunch & Technology Workshops available for Sponsorship
1:25pm - 1:30pm 5 mins
Single-Use: Case Studies and Innovations
Chairperson's Remarks
1:25pm - 1:30pm 5 mins
Interface between Early Stage and Late Stage Process Development
Chairperson's Remarks
1:25pm - 1:30pm 5 mins
Commercial Manufacturing: Beyond the Plant
Chairperson's Remarks
1:30pm - 2:00pm 30 mins
Single-Use: Case Studies and Innovations
In Process Monitoring in Single Use Manufacturing of Dendritic Cells
  • Shashi Murthy, PhD - Professor of Chemical Engineering & Sherman Center Director, Northeastern University
more

This presentation will describe a new perfusion-based single use system for the manufacturing of patient-specific, therapeutic dendritic cells and, as a case study, detail the incorporation of sensors and monitoring instrumentation to achieve monitoring of key process parameters.

1:30pm - 2:00pm 30 mins
Interface between Early Stage and Late Stage Process Development
Interface between Discovery, Early Stage Process Development and Late Stage Process Development - Presentation Title TBA
  • Duc Nguyen, PhD - Lab Head, Novartis
more
1:30pm - 2:00pm 30 mins
Commercial Manufacturing: Beyond the Plant
Unresolved Ambiguities in the Biologics Price Competition and Innovation Act (BPCIA) of 2010 Continue to Challenge Drug Product Sponsors
  • Verne Luckow, PhD, JD - Attorney-at-Law, The Intellectual Property Law Office
more

Biologics Price Competition and Innovation Act (BPCIA). I can provide an updated perspective on proposals to amend the AIA, and recent developments concerning Statutes, Regulations, Guidance Documents and Court Cases Concerning the Biologics Price Competition and Innovation Act (BPCIA).

2:00pm - 2:30pm 30 mins
Single-Use: Case Studies and Innovations
Comparison of USP <665> and BPOG Protocols for Extractables Studies of SUS Components
  • Raymond Colton, MBA - Founder, VR Analytical
more

The extent of testing for extractables from biopharmaceutical contact materials currently not defined by any published guidance. The two approaches being considered are provided by USP in a draft chapter <665> and by the BioPhorum Operations Group (BPOG) in its Extractables Protocol. Among the considerations described in these documents are the recommended solvents and extraction periods for an extractables study. While both guidelines share some of the same recommendations for these considerations, they differ in the total number of solvents recommended and in the lengths of the extraction periods. In particular, BPOG recommends testing at a higher pH compared to USP <665> and BPOG recommends testing with a high ionic strength solvent (5M NaCl). To investigate the effect of pH and ionic strength, we conducted an extractable analysis of three gamma irradiated test articles used in single use systems: a polyether sulfone filter, a tubing set, and a biocontainer bag. We tested at increasing pH and ionic strength in order to evaluate if the importance of these variables. The results of these analyses shows where each approach does or does not have merit and how the materials of construction of the test article should be a consideration in the choice of solvents.

2:00pm - 2:30pm 30 mins
Interface between Early Stage and Late Stage Process Development
Best Practices: Transferring processes from pre-clinical, to clinical, to commercial launch prep.
2:30pm - 2:35pm 5 mins
Close of Conference - See you in 2019!