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Key Sessions

Arulvathani Arudchandran, PhD

Post Approval Changes in biotechnology products: Navigate through Regulatory Requirements

FDA

S. Anne Montgomery

Cultivating a Better Working Relationship with Contract Manufacturing Organizations

BioProcess International Magazine

7:00am - 8:05am

Registration and Coffee

Showing of Streams
Showing of Streams
9:45am - 10:25am

Networking Refreshment Break in the Poster and Exhibit Hall

Showing of Streams
12:00pm - 1:25pm

Networking Lunch & Roundtable Discussions in the Poster and Exhibit Hall

Showing of Streams
Showing of Streams
3:00pm - 3:45pm

Networking Refreshment Break in the Poster and Exhibit Hall

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

Reception in the Poster and Exhibit Hall

7:00am - 8:05am 65 mins
Registration and Coffee
8:05am - 8:10am 5 mins
Keynote Presentations
Chairperson's Remarks
8:10am - 8:40am 30 mins
Keynote Presentations
Post Approval Changes in biotechnology products: Navigate through Regulatory Requirements
  • Keynote Presenter Arulvathani Arudchandran, PhD - Product Quality Reviewer OBP, OPQ, CDER, FDA
more

Introducing changes in manufacturing and in qualifying the biotech products at post approval are inevitable. However, some of these changes may bear high risk to safety and efficacy. A well-planned implementation of CMC changes should be accompanied by a comprehensive analytical comparability study as well as a robust control strategy to mitigate potential risks.  Effective use of knowledge of the product and the manufacturing process in addition to the risk management activities carried out through the life cycle of the product will help to validate the changes implemented.  Case studies on past experiences to support assessing changes are presented.

8:40am - 9:10am 30 mins
Keynote Presentations
Cultivating a Better Working Relationship with Contract Manufacturing Organizations
  • Moderator S. Anne Montgomery - Editor in Chief, BioProcess International Magazine
  • Panelist Yuyi Shen, PhD - Principal Scientist, Grifols
  • Panelist Xiao-Ping Dai, PhD - Senior Director, Head of Biologics DS Development, Celgene Corporation
  • Panelist Tad Thomas, PhD - Director and Global Lead, Biologics Process Transfer and Launch Global Biological Development, Bayer HealthCare LLC
more
9:15am - 9:45am 30 mins
Analytics, Models & Insights Track
On-demand nutrient feed during automated cell culture process: Integrating Eppendorf's Bioprocess System with Flownamics Segflow and Roche's Cedex Bio HT systems
  • Robert Berish - Scientist, Zoetis
more

Automated on-line sampling with feedback loop control from integrated third party instruments.

9:15am - 9:45am 30 mins
Early Stage Process Development
Case Study: A Molecule's Journey - Breaking Down Roadblocks to Commercial Success
  • Guillaume Plane - Global Development and Marketing Manager, BioReliance® End-to-End Solutions, MilliporeSigma
more

Navigating through the important considerations necessary to successfully bring a biologic molecule to market.When bringing a molecule from the bench to market, there are many important considerations that biopharma executives must take into account throughout the journey that will impact the success of their commercial strategy. To safeguard against development setbacks and ultimately the viability of the drug candidate, every decision made should focus on getting to the clinic as quickly as possible, but never at the expense of product quality, process efficiency, or patient safety. The key to this success is to make the right decisions at the right time.In this presentation, we will share some key considerations to help biopharmaceutical companies navigating the complexities associated with business planning, cell line development, process development, technology choices, regulatory and risk assessment. We will also cover key strategic aspects including the choice of services (CDMOs/ CMOs) providers and its impact on the commercial production strategies (insourcing vs. outsourcing).Finally we will review 2 case studies which demonstrate the importance of choosing the right service provider, because the viability of the clinical development program, and ultimately the company often rely on the capabilities, flexibility and agility of the partner along the clinical development of the molecule.

9:15am - 9:45am 30 mins
Late Stage Process Development
Track Presentation Available for Sponsorship
9:15am - 9:45am 30 mins
Commercial Manufacturing
Track Presentation Available for Sponsorship
9:45am - 10:25am 40 mins
Networking Refreshment Break in the Poster and Exhibit Hall
10:25am - 10:30am 5 mins
Analytics, Models & Insights: MES & Simulation
Chairperson's Remarks
10:25am - 10:30am 5 mins
Early Stage Process Development: Cell Culture and Media
Chairperson's Remarks
10:25am - 10:30am 5 mins
Late Stage Process Development and Commercial Manufacturing: Tech Transfer and Commercial Launch Prep
Chairperson's Remarks
10:30am - 11:00am 30 mins
Analytics, Models & Insights: MES & Simulation
System Integration for a New Large-Scale Manufacturing Facility
  • Jordan Croteau, MBA - Senior Engineer, Global Execution Systems, Biogen
more

This session will discuss design and implementation considerations for integrating large scale facility, the impact to existing facilities and integrations, and organizational readiness.

10:30am - 11:00am 30 mins
Early Stage Process Development: Cell Culture and Media
Comparison Between Fed-Batch and Perfusion Cell Culture System
  • Daryl Powers, PhD - Associate Director, Upstream Process Development, Sanofi BioPharmaceutics
more

Intensified perfusion processes provide numerous advantages over legacy perfusion processes. High cell densities and steady state of control, with the resulting high productivity and consistent product quality, have been supported by advanced perfusion technologies. Next-generation perfusion technologies also enable integration with continuous downstream unit operations, allowing for a fully continuous, highly productive, and more predictive process. Fed-batch processes have, however, been more robustly studied and extensively developed for the production of monoclonal antibodies (mAb). The lack of controlled studies comparing the two production paradigms makes platform decisions during process development difficult. This presentation compares a baseline next-generation perfusion process at Sanofi to a standard fed-batch process for the production of two different mAb’s. We have attempted to control as many conditions between the disparate production platforms as possible by using the same cell line, basal media, and process set-points within the experiment. Inherent platform differences, such as feed composition and final cell densities, lead to difficulties for exact comparisons. These unavoidable platform differences lead to the variations in performance we examined. Fed-batch and perfusion processes appear to present disparate environments and promote dissimilar metabolism, yet these stark differences do not cause major discrepancies in critical quality attributes. In a perfusion process, some product quality attributes are slightly more pure or less heterogeneous than in a fed-batch process. However, overall quality profile is largely unchanged. Our data suggests that a transition from a fed-batch to a perfusion process is a possible option that can be explored as development progresses or during life cycle management, at least in regards to product quality.

10:30am - 11:00am 30 mins
Late Stage Process Development and Commercial Manufacturing: Tech Transfer and Commercial Launch Prep
Points to Consider in QC Method Validation and Transfer for Biological Products
  • Weijun Li, PhD - Senior Manager, Analytical Transfers & Special Projects, Bayer Healthcare
more

Method validation and transfer are the core activities of analytical life cycle management. The presentation will cover the strategies and lessons learned applicable to the validation and transfer of QC routine methods for testing biological products (e.g., recombinant proteins). A risk based approach is adapted to plan and strategize the activities.

11:00am - 11:30am 30 mins
Analytics, Models & Insights: MES & Simulation
Steps for MES System Selection, Customization and Implementation
11:00am - 11:30am 30 mins
Early Stage Process Development: Cell Culture and Media
Integrated Media Blending Increases Efficiency of Clone Selection
  • David Bruehlmann, PhD - Manager, EMD Serono
more

Clone screening in the same medium leads to the selection of the best adapted clones and not the best one per se. Media blending in 96-deep-well plate fed-batch cultures produced great growth and productivity diversities. For every clone conditions were identified resulting in higher titers than with the proprietary media, showing a clear advantage of blending early in selection.

11:00am - 11:30am 30 mins
Late Stage Process Development and Commercial Manufacturing: Tech Transfer and Commercial Launch Prep
Tech Transfer from Late Stage to Commercial Launch - Presentation Title TBA
  • Padmadhar Madupu, MS - Technical Manager, Pfizer
more
11:30am - 12:00pm 30 mins
Analytics, Models & Insights: MES & Simulation
Monitoring, Modeling and Control (M3C) for Robust Mammalian Cell Ceulture Bioprocess
11:30am - 12:00pm 30 mins
Early Stage Process Development: Cell Culture and Media
Cell culture media: an API or ancillary material?
  • David Brindley, DPhil, MEng, FRSA - Managing Partner, Biolacuna & Senior Research Fellow, Nuf eld Department of Paediatrics, University of Oxford
more

Cell culture media is a process and product critical component. Advances in genetically (re)engineered cell and gene therapies pose greater API consistency challenges for manufacturers. The distinction between process starting materials, reagents, ancillary materials and final APIs is increasingly unclear.

11:30am - 12:00pm 30 mins
Late Stage Process Development and Commercial Manufacturing: Tech Transfer and Commercial Launch Prep
Challenges in Development of a High Concentration Liquid Formulation for mAb Process
  • Daniel Chen - Scientist, Protein Science, Boehringer Ingelheim
more
12:00pm - 1:25pm 85 mins
Networking Lunch & Roundtable Discussions in the Poster and Exhibit Hall
1:25pm - 1:30pm 5 mins
Analytics, Models & Insights Track
Chairperson's Remarks
  • Eric Langer - President & Managing Partner, BioPlan Associates
more
1:25pm - 1:30pm 5 mins
Early Stage Process Development: Cell Culture and Media
Chairperson's Remarks
1:25pm - 1:30pm 5 mins
Late Stage Process Development: Case Studies on Viral Filtration
Chairperson's Remarks
1:25pm - 1:30pm 5 mins
Commercial Manufacturing: Case Studies - Scale-Up
Chairperson's Remarks
  • Shawn Liu, PhD - Chief Scientist & Department Head, Bayer Healthcare LLC
more
1:30pm - 2:00pm 30 mins
Analytics, Models & Insights Track
Next Generation Process Science: Beyond Proteins
  • Nick Timmins, PhD - Vice President, Process Science, Bluerock Therapeutics
more

Manufacture of living cell products presents unique challenges due to limited understanding of the intrinsic biology and how process conditions impact upon cell phenotype and function. Fresh approaches to developing process and product understanding, and leveraging the knowledge that we do have to deliver robust and efficient outcomes, are needed.

1:30pm - 2:00pm 30 mins
Early Stage Process Development: Cell Culture and Media
Cell-Controlled Hybrid Perfusion/Fed-Batch Effectively Circumvents the Inherent Limitations of Fed-Batch
  • Ana Maria Ovalle - Senior Associate Scientist, Pfizer Inc.
more

The productivity of fed-batch cultures are inherently limited because while some metabolites produced during the growth phase are sometimes reabsorbed, those that accumulate, along with unused components in nutrient feeds, ultimately slow growth and decrease productivity.  Using a highly efficient mode of cell-controlled perfusion followed by a short-duration fed-batch operation enables volumetric productivities approaching 1.0 gram/L/day for several cell lines.  

1:30pm - 2:00pm 30 mins
Late Stage Process Development: Case Studies on Viral Filtration
Two Decades of Exploration in Viral Filtration
  • Shawn Liu, PhD - Chief Scientist & Department Head, Bayer Healthcare LLC
more
1:30pm - 2:00pm 30 mins
Commercial Manufacturing: Case Studies - Scale-Up
Case Study: Alleviating Downstream Bottlenecks to Accommodate Increased Titers of a Commercial mAb Process
  • Kimberly Fuller - Scientist, Bristol-Myers Squibb
more

Implementing process improvements for a commercial mAB manufacturing process creates unique challenges in balancing the risks and benefits to product quality/manufacturing/regulatory. Furthermore, process improvements upstream resulting in higher titers may not be feasible for implementation given downstream process constraints. This case study of a commercial mAB manufacturing process reviews the strategy of identifying and implementing manufacturing and process improvements to alleviate downstream bottlenecks in order to accommodate higher titers.

2:00pm - 2:30pm 30 mins
Analytics, Models & Insights Track
Monitoring and Controlling Viable Biomass in Bioprocesses Using Dielectic Spectroscopy for PAT Applications
  • Aditya Bhat, PhD - Director of Technology, Aber Instruments, Inc.
more

The radio-frequency impedance method for real-time detection of viable biomass is established in biopharmaceutical applications. This method provides real-time information on live biomass and is used to monitor/control processes and make critical decisions. This presentation covers the principle of capacitance technology and its benefits. Applications of the technology across processes that make it a robust PAT tool will be discussed.

2:00pm - 2:30pm 30 mins
Early Stage Process Development: Cell Culture and Media
Overcome Challenges to Successful Development of Chemically Defined Media Through Manipulation of the TCA Cycle in CHO Cells
  • Le You, PhD - Scientist, Process Development, Ambrx
more

Developing chemically defined media suited for Chinese hamster ovary (CHO) cell lines is essential for the stable production of recombinant therapeutic protein. The process, however, is challenging and extensive because of the complexity of cellular metabolism and the associated phenotypic variations. In this case study, we applied the metabolism analysis in our development process of chemically defined media for the CHO cell lines to produce monoclonal antibodies (mAbs) containing non-native amino acids. We observed that the TCA cycle was most actively responded to the change of the medium composition. Adjusting the medium composition to regulate the TCA cycle led to the enhanced productivity and product quality. Using metabolism analysis showed great potential in guiding the development of the proprietary chemically defined media to enhance the product quality and productivity in recombinant therapeutic proteins-producing CHO cells.

2:00pm - 2:30pm 30 mins
Late Stage Process Development: Case Studies on Viral Filtration
Mitigation of Risk of Viral Contamination of Media Using Upstream Barrier Method
  • Kathryn Remington, PhD - Principal Scientist, Field Development Services, BioReliance
more

Ensuring the viral safety of culture media and other materials used in production of biopharmaceuticals is a step to the prevention of viral contamination. In spite of careful selection and testing of raw materials and process intermediates, contamination events have occurred. In an effort to mitigate the risk of viral contamination many manufacturers have implemented upstream barrier methods to treat media and other raw materials prior to culturing cells that produce therapeutic proteins. Along with filtration, exposure to UVC and high temperature short time (HTST) can be used as upstream barriers to potential viral contamination. This paper will discuss use of barrier methods to complement a traditional viral safety strategy for recombinant proteins, vaccines and other biopharmaceuticals. The efficacy of HTST to inactivate small non-enveloped viruses and data for the inactivation of viruses by UVC will be shown, and the utility of these methods will be compared. The use of upstream barrier methods complements a viral safety strategy to further reduce the risk of a potential contamination event.

2:00pm - 2:30pm 30 mins
Commercial Manufacturing: Case Studies - Scale-Up
Evaluation Criteria for Process Validation
2:30pm - 3:00pm 30 mins
Technology Workshop 1
A New Media Panel that Unlocks Your Cells' Potential
  • Jenny Bang - Manager, Research and Development, Irvine Scientific
more

Irvine Scientific utilizes a Rational Culture Media Design™ approach to media development. Our media development approach is designed to meet specific needs of customers’ unique production processes. In this workshop, we will demonstrate our media design and development capabilities and introduce our new media panel that can be utilized for CHO fed-batch and HD perfusion process optimization.

2:30pm - 3:00pm 30 mins
Technology Workshop 2
OPUS® 80R cm column - Repligen
  • Fletcher Malcolm - Director, Product Manager, Repligen
more
2:30pm - 3:00pm 30 mins
Technology Workshop 3
Planova™ Virus Filtration as a Highly Effective Robust Step in Viral Clearance
  • Esha Vyas - Field Applications Manager, Asahi Kasei Bioprocess America
more

Virus filtration has been demonstrated to be effective for viral clearance. Planova™ 20N and BioEX filters are highly robust for a wide range of protein types and concentrations, achieving a high small virus logarithmic reduction value > 4 and showing compatibility with various operating parameters including pH and conductivity while maintaining robust filtration flux and capacity.

2:30pm - 3:00pm 30 mins
Technology Workshop 4
Technology Workshop Presented by GE Healthcare
3:00pm - 3:45pm 45 mins
Networking Refreshment Break in the Poster and Exhibit Hall
3:45pm - 4:15pm 30 mins
Analytics, Models & Insights Track
Is Single-Use Cost Effective?
  • Eric Langer - President & Managing Partner, BioPlan Associates
more
3:45pm - 4:15pm 30 mins
Early Stage Process Development: Non-Platform Molecules
Selectivity Analysis Cation-Exchange Chromatography on Protein Impurity Separation
  • Keith Selvitelli - Senior Associate Scientist, Process Biochemistry, Biogen
more

Unique selectivity of mixed mode chromatography resins has been widely demonstrated to provide noticeable process advantages over traditional chromatographic media. In addition, the hydrophobic nature of mixed-mode resins has been utilized for aggregate removal as a viable polishing step in many post-proteinA platform processes. For non-platform molecules, process development challenges are multi-faceted and often require orthogonal methodologies. In this context, the effects of hydrophobic and charged moieties on multimodal cation-exchange ligands were examined by studying protein retention behavior on commercially available media, such as CaptoMMC, CaptoMMC ImpRes, Nuvia cPrime and CMM Hypercel. A novel therapeutic protein and an enriched dimer version of the protein were employed to characterize protein – ligand interactions. Binding of these proteins was evaluated as a function of feed, salt concentration and pH in the presence of various mobile phase modulators. Information assembled was applied towards identifying operational conditions that enable sufficient aggregate and impurity removal. In addition to the intermediate stability and virus clearance studies, a polishing step was successfully designed and implemented during a GMP manufacturing campaign at 2000L scale.

3:45pm - 4:15pm 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.

3:45pm - 4:15pm 30 mins
Commercial Manufacturing: Platform
How to select the "right" CMO at early stage CMC Development.
  • Qinghai Zhao, PhD - Vice President, Technical Development and Manufacturing, FortySeven Inc
more

This presentation will include information on selecting an “ideal” CMO of early stage CMC development and manufacturing for small biotech companies, a one-stop shop model for early stage CMC development, Gene to CTM (clinical trial material), and thoughts on digital to digital (from receiving DNA sequence to IND/IMPD CTD). We’ll also discuss three elements in selecting a CMO: Quality, Timeline and Cost, a quality system to cover all GMP activities (DS/DP/Labelling/QP release), an example to deliver CTM in 18 months, thoughts on cost control for using one CMO with minimum internal resource need, and a platform approach for program success.

4:15pm - 4:45pm 30 mins
Analytics, Models & Insights Track
An Industry Perspective: Continued Process Verification & Analytics
4:15pm - 4:45pm 30 mins
Early Stage Process Development: Non-Platform Molecules
Challenges and Strategies of Downstream Processing for a Complex Bispecific Antibody
  • Ji Zheng, PhD - Associate Director, Celgene
more

Bispecific antibodies are antibodies with dual specificity to two different types of antigens. The purification of these bispecific antibodies can be complex and a platform approach is not always feasible for the downstream processing. This paper will discuss a case study for the challenges associated with the manufacturing and the strategies that can be implemented to overcome those challenges.

4:15pm - 4:45pm 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
4:15pm - 4:45pm 30 mins
Commercial Manufacturing: Platform
Automating Platform Technology and Science
4:45pm - 5:15pm 30 mins
Analytics, Models & Insights Track
Utilizing Simulation and Optimization Techniques to Evaluate Different Car-T Cell Therapy Manufacturing Paradigms
  • Jon Gunther, PhD - Associate Director, Juno Therapeutics
more
4:45pm - 5:15pm 30 mins
Early Stage Process Development: Non-Platform Molecules
Non-Platform biologics process development and technical transfer for early clinical phase API production
  • Christopher Rode - Scientific Director, API-Large Molecule/Pharmaceutical Development Manufacturing Sciences, Janssen R&D
more
4:45pm - 5:15pm 30 mins
Late Stage Process Development: Raw Materials
Process Analytics to Control Variability
4:45pm - 5:15pm 30 mins
Commercial Manufacturing: Platform
Automating Platform Technology and Science
5:30pm - 6:30pm 60 mins
Reception in the Poster and Exhibit Hall