Informa Life Sciences is part of the Knowledge and Networking Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa
Key Sessions

Kimball Hall

Redefining Competition – Thinking about our Industry in a Revolutionary Way

Genentech, Inc.

Arulvathani Arudchandran, PhD

Post Approval Changes in biotechnology products: Navigate through Regulatory Requirements

FDA

7:30am - 8:00am

Registration and Coffee

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

Networking Refreshment Break in the Poster and Exhibit Hall

More
Showing of Streams
Showing of Streams
12:00pm - 1:15pm

Networking Lunch in the Poster and Exhibit Hall

More
Showing of Streams
Showing of Streams
2:55pm - 3:45pm

Final Networking Refreshment Break in the Poster and Exhibit Hall

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

Reception at ENO Wine Bar San Francisco - 320 Geary Street, San Francisco, CA

Enjoy drinks and appetizers while networking with fellow attendees at the ENO Wine Bar located at 320 Geary Street, San Francisco.

More
7:30am - 8:00am 30 mins
Registration and Coffee
8:00am - 8:05am 5 mins
Keynote Presentations
Chairperson's Remarks
  • Amit Dua - Global Marketing Strategy Leader, GE Healthcare
8:05am - 8:40am 35 mins
Keynote Presentations
Redefining Competition – Thinking about our Industry in a Revolutionary Way
  • Kimball Hall - Senior Vice President and Head of Drug Substance Manufacturing, Pharma Technical Operations, Genentech, Inc.
8:40am - 9:10am 30 mins
Info
Keynote Presentations
Post Approval Changes in biotechnology products: Navigate through Regulatory Requirements
  • Keynote Presenter Arulvathani Arudchandran, PhD - Product Quality Reviewer OBP, OPQ, CDER, FDA

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.

9:15am - 9:55am 40 mins
Networking Refreshment Break in the Poster and Exhibit Hall
9:55am - 10:00am 5 mins
Analytics and Models for Bioprocessing: Insights from R&D to Manufacturing
Chairperson's Remarks
  • Eric Langer - President & Managing Partner, BioPlan Associates
9:55am - 10:00am 5 mins
Early Stage Process Development: Cell Culture and Media
Chairperson's Remarks
  • David Brindley, DPhil, MEng, FRSA - Managing Partner, Biolacuna & Senior Research Fellow, Nuf eld Department of Paediatrics, University of Oxford
9:55am - 10:00am 5 mins
Late Stage Process Development and Commercial Manufacturing: Tech Transfer and Commercial Launch Prep
Chairperson's Remarks
  • Amit Dua - Global Marketing Strategy Leader, GE Healthcare
9:55am - 10:00am 5 mins
Track Presentations Sponsored by Sartorius
Chairperson's Remarks
  • Mario Becker - Director, Sartorius Stedim Biotech
10:00am - 10:30am 30 mins
Info
Analytics and Models for Bioprocessing: Insights from R&D to Manufacturing
System Integration for a New Large-Scale Manufacturing Facility
  • Jordan Croteau - Senior Engineer, Global Execution Systems, Biogen

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

10:00am - 10:30am 30 mins
Info
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

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.

10:00am - 10:30am 30 mins
Info
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

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.

10:00am - 10:30am 30 mins
Info
Track Presentations Sponsored by Sartorius
Development of ‘ambr 250 perfusion’ – A Novel Automated Single-Use Perfusion Mini-Bioreactor
  • Melisa Carpio - Field Marketing Manager Fermentation Technologies, Sartorius Stedim North America Inc.

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

10:30am - 11:00am 30 mins
Info
Analytics and Models for Bioprocessing: Insights from R&D to Manufacturing
Using Protein Sequence Variant Analysis to De-risk Clinical Candidates at the Cell Line Selection Stage
  • Heather Oakes - Mass Spectrometry Lead Scientist, Lonza Pharma & Biotech

Protein sequence variants are changes to a theoretical amino acid sequence. We will present an approach to sequence variant analysis driven by statistical tools in early development. Mechanisms of misincorporation and correlation with cell line stability at generation numbers representative of large-scale biomanufacturing were investigated. Our approach has been optimized to have no impact on overall cell line construction timeline.

10:30am - 11:00am 30 mins
Info
Early Stage Process Development: Cell Culture and Media
Integrated Media Blending Increases Efficiency of Clone Selection
  • David Bruehlmann, PhD - Manager, EMD Serono

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.

10:30am - 11:00am 30 mins
Late Stage Process Development and Commercial Manufacturing: Tech Transfer and Commercial Launch Prep
Scalability Considerations for Technology Transfer Structures, Tools, and Systems
  • Jasmina Xie - Senior Process Development Engineer, Technology Transfer, Bayer
10:30am - 11:00am 30 mins
Info
Track Presentations Sponsored by Sartorius
Gain manufacturability information for downstream processing already during your candidate selection
  • Michael Dosmar - Senior Technology Expert Crossflow Filtration, Sartorius Stedium Biotech GmbH

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

In This workshop the working principles of the multi-parallel system and examples from real product condition will be presented.

11:00am - 11:30am 30 mins
Info
Analytics and Models for Bioprocessing: Insights from R&D to Manufacturing
Real-time PQ analysis via 2D UPLC
  • Anoushka Durve, - Manager, Analytical Science, Boehringer Ingelheim

Anoushka Durve, Dharani Vora, Jeff Goby, Eike Zimmermann and Kenji Furuya

During the development of therapeutic monoclonal antibodies (mAbs), monitoring protein productivity along with product quality (PQ) attributes is essential. There is limited understanding on how PQ profiles change with process conditions or culture duration. Real-time monitoring capabilities would allow us to understand such changes during upstream processing. At Boehringer Ingelheim, Fremont, we have already established the Waters PATROL™ UPLC to measure real-time daily titers during culture duration. Product quality testing, however, requires samples to be affinity purified, prohibiting the use of the PATROL™ UPLC directly for permeate analysis, for e.g. size variants by SEC or charge variants by CEX. We thus have enhanced the PATROL™ system to a 2D platform with protein A purification in the 1st dimension followed by a PQ assay in the 2nd dimension. This system allows real-time analysis of PQ attributes such as size or charge variants directly during cell culture samples, without the time-consuming affinity purification operation. In this talk, we have demonstrated a proof of concept to utilize the 2D PATROL™ UPLC to monitor PQ attributes during cell culture processing.

Take home message- 

The impact of process conditions and culture duration on mAb size and charge variant profiles can be monitored in real-time during continuous cell culture processing using the enhanced 2D PATROL™ UPLC.

11:00am - 11:30am 30 mins
Info
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

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.

11:00am - 11:30am 30 mins
Late Stage Process Development and Commercial Manufacturing: Tech Transfer and Commercial Launch Prep
Tech Transfer Simplified with Model-Based Process Fit and Process Control
  • Steven Rose, MS - Director, Bioprocess Engineering, MedImmune
11:00am - 11:30am 30 mins
Info
Track Presentations Sponsored by Sartorius
Development of a Process Monitoring System: 0 – 60 in 9 months
  • Jeffrey Simeone, MSc. - Associate Director, Technical Services, Shire

This presentation summarizes the rapid deployment of a real-time multivariate process monitoring system at Shire. It will cover the entire process starting from system conception to implementation of SIMCA Online, which took less the 9 months. The talk identifies the system configurations within Shire that enabled the quick implementation as well as the challenges overcome including shifting the company culture.

11:30am - 12:00pm 30 mins
Info
Analytics, Models & Insights Track
On Demand Nutrient Feed During Automated Cell Culture Process – Integrating an Eppendorf Bioprocess Controller, with the Flownamics Seg-Flow and the Roche CustomBiotech Cedex Bio HT Analyzer
  • Robert Berish - Scientist, Zoetis

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

11:30am - 12:00pm 30 mins
Info
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

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.

11:30am - 12:00pm 30 mins
Late Stage Process Development
Saturn™ and FlexFactory™: Transforming an Existing Facility to Multi-Product Ballroom
  • Thomas Page, PhD - Vice President, Engineering and Asset Development, Fujifilm Diosynth Biotechnologies
12:00pm - 1:15pm 75 mins
Networking Lunch in the Poster and Exhibit Hall
1:15pm - 1:20pm 5 mins
Analytics and Models for Bioprocessing: Insights from R&D to Manufacturing
Chairperson's Remarks
  • Jordan Croteau - Senior Engineer, Global Execution Systems, Biogen
1:15pm - 1:20pm 5 mins
Early Stage Process Development: Cell Culture and Media
Chairperson's Remarks
  • Ashley Hesslein, PhD - Associate Director in Biological Development, Bayer Healthcare LLC
1:15pm - 1:20pm 5 mins
Late Stage Process Development: Case Studies on Viral Filtration
Chairperson's Remarks
  • Matthew Luther - Development Associate II, Late Stage Purification Development, Alexion
1:15pm - 1:20pm 5 mins
Commercial Manufacturing: Case Studies - Scale-Up
Chairperson's Remarks
  • Tiffany Rau, PhD - Senior Consultant, BioProcess Technology Consultants, Inc.
1:20pm - 1:50pm 30 mins
Info
Analytics and Models for Bioprocessing: Insights from R&D to Manufacturing
Next Generation Process Science: Beyond Proteins
  • Nick Timmins, PhD - Vice President, Process Science, Bluerock Therapeutics

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.

1:20pm - 1:50pm 30 mins
Info
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.

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.  

1:20pm - 1:50pm 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
1:20pm - 1:50pm 30 mins
Info
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

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.

1:50pm - 2:20pm 30 mins
Info
Analytics and Models for Bioprocessing: Insights from R&D to Manufacturing
Monitoring and Controlling Viable Biomass in Bioprocesses Using Dielectic Spectroscopy for PAT Applications
  • Aditya Bhat, PhD - Director of Technology, Aber Instruments, Inc.

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.

1:50pm - 2:20pm 30 mins
Info
Early Stage Process Development: Cell Culture and Media
Lessons Learned: Progressing a CHO Expression System Fed-Batch Process from the Incubator to Bench-Scale Bioreactor
  • Robert Voyer, MASc, National Research Council of Canada

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.

1:50pm - 2:20pm 30 mins
Info
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

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.

1:50pm - 2:20pm 30 mins
Commercial Manufacturing: Case Studies - Scale-Up
Process Optimization after Commercialization
  • Nikki Nogal, Ph.D. - Senior Consultant Biologics Product Development, Latham BioPharm Group
2:25pm - 2:55pm 30 mins
Info
Technology Workshop 1
A New Media Panel that Unlocks Your Cells' Potential
  • Jenny Bang - Manager, Research and Development, Irvine Scientific

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.

2:25pm - 2:55pm 30 mins
Info
Technology Workshop 2
Scaling up? No problem with new 80cm diameter pre-packed OPUS columns
  • Fletcher Malcolm, MBA - Director, Product Manager, Repligen

The technical and economic benefits of ready-to-use, pre-packed chromatography columns have been proven and documented. The question remains, how large can we go? This presentation will show how the unique design of the new 80cm pre-packed OPUS column delivers chromatographic performance, and how usage can result in substantial cost and time savings for clinical and commercial scale manufacturing.  

2:25pm - 2:55pm 30 mins
Info
Technology Workshop 3
Minimizing Resources in Developing Commercial Virus Filtration Processes with Planova™ BioEX
  • Esha Vyas - Field Applications Manager, Asahi Kasei Bioprocess America

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.

2:25pm - 2:55pm 30 mins
Info
Technology Workshop 4
Pinpoint your Key Parameters for a Successful Perfusion Process
  • Helena Öhrvik, PhD - Scientist, R&D Bioprocess, GE Healthcare

The bioproduction field is evolving rapidly to meet the challenges brought by new trends. One trend is exploring the use of continuous processes, including perfusion, from lab scale to manufacturing. Continuous processing supports productivity and intensification by providing opportunities to reduce costs, improve process efficiency, and enhance product quality. One major challenge is to design a high-performing continuous process at low cost. Achieving this goal requires optimization of several key steps. These steps include media composition, bioreactor performance, perfusion strategy, cell retention technology, and downstream integration. In this workshop, we will discuss strategies for perfusion process optimization and scale-down model development. Furthermore, we will highlight the potential and challenges with perfusion. We will finish by discussing components of a high-performing perfusion process.

2:55pm - 3:45pm 50 mins
Final Networking Refreshment Break in the Poster and Exhibit Hall
3:45pm - 4:15pm 30 mins
Info
Early Stage Process Development: Non-Platform Molecules
Selectivity Analysis Cation-Exchange Chromatography on Protein Impurity Separation
  • Keith Selvitelli - Senior Associate Scientist, Process Biochemistry, Biogen

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
Info
Late Stage Process Development: Recovery and Purification
Process Development: The Key to a Successful Biomanufacturing Strategy
  • Brad Johnson, PhD - Head of Purification Development, Patheon

Biopharma companies face many challenges and critical decisions when developing a new biologic drug. The decision to outsource the development of a molecule to a CDMO involves much more than reaching internal capacity. Finding the right capable partner to achieve your business objectives can be just as important as determining the right biologic manufacturing process. During our session, we will evaluate the decisions around outsourcing to a CDMO and share case studies that demonstrate examples of when outsourcing development actually improved the overall biomanufacturing strategy.

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

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
Info
Early Stage Process Development: Non-Platform Molecules
Challenges and Strategies of Downstream Processing for a Complex Bispecific Antibody
  • Ji Zheng, PhD - Associate Director, Celgene

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
Info
Late Stage Process Development: Recovery and Purification
Challenges to making a ready to fill ASO formulation for intrathecal delivery
  • Hien Nguyen - Associate Scientist III, Biogen

Recently, Biogen has developed an all-aqueous, platform purification process for its antisense oligonucleotide (ASO) portfolio. Due to the downstream process now being all aqueous and with the intrathecal delivery of the ASOs, we needed a robust control strategy to ensure the final drug substance formulation meets excipients and endotoxin targets. This talk describes the results and highlights the challenges we encountered.

4:45pm - 5:15pm 30 mins
Analytics and Models for Bioprocessing: Insights from R&D to Manufacturing
Utilizing Simulation and Optimization Techniques to Evaluate Different Car-T Cell Therapy Manufacturing Paradigms
  • Jon Gunther, PhD - Associate Director, Juno Therapeutics
4:45pm - 5:15pm 30 mins
Early Stage Process Development: Non-Platform Molecules
Open time slot, feel free to attend another presentation at this time.
4:45pm - 5:15pm 30 mins
Info
Late Stage Process Development: Recovery and Purification
Assessment of Clarification Options for High Cell Density Cultures
  • Kirk McLean - Senior Development Scientist, Bayer Healthcare

Biotech companies have systematically increased titers and cell densities for mammalian cell manufacturing of biotherapeutics partly due to advances in media / feed compositions and process intensification. Demands for cell and particle removal during clarification processes have correspondingly increased. Here we present a review of clarification approaches focusing on application to high cell density feeds.

Authors: Kirk McLean, Edgar Henriquez, Roy Kimura, Marcus Lee, Edward Long, Shilpi Patel, Isu Yoon, Hendri Tjandra, Paul Wu, Steve Garger, Ashley Hesslein

5:30pm - 6:30pm 60 mins
Info
Reception at ENO Wine Bar San Francisco - 320 Geary Street, San Francisco, CA

Enjoy drinks and appetizers while networking with fellow attendees at the ENO Wine Bar located at 320 Geary Street, San Francisco.