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Preclinical Scale Bioprocessing
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Agenda
Accelerating Early Development Timelines and Working with Limited Resources
7:45
Registration and Networking Coffee
8:30
Chairperson's Opening Remarks
Susan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants
Susan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants
Keynote Presentation
8:45
Accelerating Development - Balancing Speed and Risk through a Process TrajectoryWhile speed of early development is highly desired, failures and poorly developed processes can result in substantial program delays. By combining a platform process along with a process trajectory, rapid timelines can still be met that minimize unnecessary risk and cost, while ensuring critical development work is completed. Key strategies will be discussed that optimize the time to successful IND filings.
Thomas M. Spitznagel, Ph.D., Vice President, BioPharmaceutical Development, Human Genome Sciences, Inc.
9:30
Front-Loaded Early Development to Increase Project Probability of Success
Making decisions based on substantial preclinical data packages and providing choices within a project will be central to future success in the biopharmaceutical industry. This talk will discuss parallel processing and early development strategies to increase project success rates in preclinical development.
Steven Lang, Ph.D., MBA, Associate Director, Biologics Research, Centocor R&D, a division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Making decisions based on substantial preclinical data packages and providing choices within a project will be central to future success in the biopharmaceutical industry. This talk will discuss parallel processing and early development strategies to increase project success rates in preclinical development.
Steven Lang, Ph.D., MBA, Associate Director, Biologics Research, Centocor R&D, a division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
10:00
Networking Refreshment Break
10:30
Case
Study
The Benefits and Consequences of Decisions to Delay Specific Development Steps Until after Animal Studies or Clinical POCStudy
In the development of medical countermeasures, there is a balancing act between what should be achieved during development and what can be performed given limited funding and resources. The needs of the warfighter and demands for protection expedite this process. For one product, this meant formulation studies for process intermediates, purification process optimization, and accelerated stability studies had to wait until after the Phase 1 clinical study.
Leonard A. Smith, Ph.D., Senior Research Scientist, United States Army Medical Research Institute for Infectious Diseases
Optimizing Early Upstream Processes
11:00
Case
Study
Development of High Cell Mass Cell Banks for Factory of the FutureStudy
This abstract was not available at the time of printing the brochure.
Sam Yaghmour, MS, Senior Associate Scientist, Process Development, Amgen Inc.
Technology Workshop
11:30
QMCF Technology, the stable episomal system, can be used for production of various recombinant proteins, antibodies and VLPs in mammalian (CHO or 293) cells. Stable maintenance and replication of expression vector in appropriate cell lines in extended timeframe ensures high yields and opportunity to generate production cell banks in order to conveniently scale-up cell culture.
Mart Ustav, Ph.D., Founder and Chief Executive Officer, Icosagen Cell Factory Ltd., Estonia
12:00
Session Ends; Lunch on Your Own
1:40
Chairperson's Opening Remarks
Jonathan Romero, Ph.D., Senior Engineer, Biopharmaceutical Development, Biogen Idec, Inc.
Jonathan Romero, Ph.D., Senior Engineer, Biopharmaceutical Development, Biogen Idec, Inc.
1:45
Case
Study
Strategies for Streamlining Cell Line Screening and Selection for use in Early DevelopmentStudy
As demand increases for efficient and streamlined production processes of therapeutic proteins, improvements in the process of cell line screening and clone selection become more important. We have developed an integrated cell line development workflow that incorporates the ClonePixFL workstation and a novel 24-well scale-down cell culture screening platform designed to quickly identify high producing clones in transfected CHO populations expressing biotherapeutic proteins.
Christina Alves, Ph.D., Scientist, Biogen Idec, Inc.
2:15
Case
Study
Evolving Abbott Cell Culture Platform for Preclinical/Clinical Production from Hydrolysate-based to Chemically-defined for Both Cell Line and Process Development within Project TimelineStudy
The industry has been moving toward chemically defined cell culture processes to mitigate the risks derived from the usage of complex raw materials. We adopted this strategy and developed a novel chemically defined medium (CDM) system. The newly developed CDM supports robust cell growth with decent titer and is more cost effective than the conventional hydrolysate-based media. We completely transformed our platform from cell line development to 3000 L scale GMP manufacturing into the new CDM for all phase I/II projects, without any pause on the continuum of pipeline flow.
John C. H. Fann, Ph.D., Senior Group Leader, Cell Culture, Abbott Bioresearch Center
2:45
Case
Study
Predicting Stability of Cell Line Productivity in Early DevelopmentStudy
One of the most important objectives to ensure successful and cost-effective manufacture of a therapeutic protein is development of a cell line that maintains stable productivity from culture expansion through bioreactor production. This presentation will focus on the application of a flow cytometry method for predicting cell line stability in early cell line development to facilitate selection of the most suitable clone for manufacturing.
Dawn Ellis, Research Scientist, Centocor R&D, a division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
3:15
Networking Refreshment Break; Opening of Poster and Exhibit Hall
Single Use Technology for Lab to Pilot Scale Production
4:00
Case
Study
A Comparative Study of Process Performance and Quality for Small Scale Single Use Bioreactor SystemsStudy
This abstract was not available at the time of printing the brochure.
Rajesh Krishnan, Ph.D., Associate Director, Merck
Optimizing Early Downstream Processes
4:30
Case
Study
Robust On-Column Conversion of IgG1 Trisulfide Linkages to Native DisulfidesStudy
Trisulfide bond formation is a common source of molecular heterogeneity in immunoglobulins that has no observable effect on function. To minimize the heterogeneity of therapeutic MAb preparations a routine procedure for elimination of trisulfides is desirable. A trisulfide moiety located within the heavy-light chain linkage of a recombinant IgG1 MAb was eliminated by a robust REDOX wash performed during column purification. Therefore trisulfide heterogeneity may be eliminated from IgG1 molecules via a convenient and controllable purification step.
David Evans, Ph.D., Manager, Commercial CMC, Biogen Idec, Inc.
5:00
Case
Study
How the Development of Novel Proteins fit into a Platform-based Downstream Purification ProcessStudy
Process development for novel proteins presents new challenges due to their unique biochemical and structural features. Novel proteins often require different chromatography and viral inactivation steps than those used in platform processes. Still, efficient development is needed to comply with timelines, and the expectation for successful manufacturing campaigns remains. A case study with examples where the novel protein does, and does not fit, into an existing platform will be presented along with lessons learned.
Diana Chinchilla, Ph.D., Senior Scientist, Purification Sciences, Human Genome Sciences, Inc.
5:30
Networking Happy Hour in Poster and Exhibit Hall
8:00
Networking Coffee
8:40
Chairperson's Opening Remarks
Steven Lang, Ph.D., MBA, Associate Director, Biologics Research, Centocor R&D, a division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Steven Lang, Ph.D., MBA, Associate Director, Biologics Research, Centocor R&D, a division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Keynote Presentation
8:45
Biosimilar Development: How will this Impact Early Process and Analytical Development?
Major pharmaceutical companies and numerous small start-ups are racing to develop biosimilars within a brief window of opportunity. The primary goal of process and analytical development is to achieve comparability with originator's drug without the knowledge of the originator's process. Starting with different cell lines and processes, a thorough comparability protocol is needed. The success of process development will depend on having a robust analytical capability. Developing countries such as BRIC have long history of biosimilar development, and other targeted markets will also impact the quality of development work.
Speaker TBA
Major pharmaceutical companies and numerous small start-ups are racing to develop biosimilars within a brief window of opportunity. The primary goal of process and analytical development is to achieve comparability with originator's drug without the knowledge of the originator's process. Starting with different cell lines and processes, a thorough comparability protocol is needed. The success of process development will depend on having a robust analytical capability. Developing countries such as BRIC have long history of biosimilar development, and other targeted markets will also impact the quality of development work.
Speaker TBA
The Benefits and Pitfalls of Platformed Process Development
9:15
Case
Study
Development of a Non Antibody Platform Approach for Process and Analytical Development for Similar-in-Class MoleculesStudy
In the past 15 years, much attention has been paid to platform approaches as a way to decrease drug development cycle times. The rationale behind this approach is that these molecules are similar-in-class and can leverage many of the lessons learned from previous molecules. Allergan Biologics has used this approach for its new molecular entity development. Allergan Biologics Development was able to decrease the development cycle time of a similar in class biologic derivative using lessons learned from two previous similar-in-class biologics.
Michael Molony, Director, CMC Team Leader, Biologics Development, Allergan
9:45
Case
Study
Platform Optimization: Identifying Cost and Time Savings with an Existing Process PlatformStudy
This abstract was not available at the time of printing the brochure.
Xinfang Li, Ph.D., Senior Scientist, Process Science and Engineering, ImmunoGen, Inc.
10:15
Networking Refreshments, Exhibit and Poster Viewing
Planning for the Scale Up of Preclinical Scale Processes
10:45
Reducing the Effects of Scale-Up Issues and Eliminating Animal Based Components from Preclinical Scale Processes
Bioreactor design and engineering can eliminate many factors when scaling up a fermentation process. Tank geometry, mixing issues, oxygen demands can be easily removed from the equation when scaling up a process for preclinical manufacturing. Taking precautions and steps to eliminate animal based components and developing a protocol that achieves similar results as animal based medias will reduce at least one of the hurdles prior to FDA compliance.
Barney B. Woodard, Ph.D., Director, Bioprocess Scale-Up Facility, University of Maryland
Bioreactor design and engineering can eliminate many factors when scaling up a fermentation process. Tank geometry, mixing issues, oxygen demands can be easily removed from the equation when scaling up a process for preclinical manufacturing. Taking precautions and steps to eliminate animal based components and developing a protocol that achieves similar results as animal based medias will reduce at least one of the hurdles prior to FDA compliance.
Barney B. Woodard, Ph.D., Director, Bioprocess Scale-Up Facility, University of Maryland
11:15
Case
Study
Scale-down Strategies to Predict Large Scale Centrifuge-Depth Filtration PerformanceStudy
This abstract was not available at the time of printing the brochure.
Jonathan Romero, Ph.D., Senior Engineer, Biopharmaceutical Development, Biogen Idec, Inc.
Technology Workshop
11:45
Stable cell line development is a critical phase of biotherapeutic development. While several CHO based platforms are widely marketed, they are costly to access—even for research use only evaluation. To enable everyone to perform stable cell line development, we have developed a kit that allows users to go from transfection to stable clone in ~4 months, with titers of ~1 g/L for an un-optimized simple glucose fed batch process, up to 3 g/L when more complex nutrient feeds are employed. Research use rights are granted upon kit purchase. Commercial licensing only requires a one-time fee.
Peggy Lio, Senior Process Science Fellow, Bioproduction, Life Technologies
12:15
Networking Luncheon, Exhibit and Poster Viewing
1:40
Chairperson's Opening Remarks
Rajesh Krishnan, Ph.D., Associate Director, Merck
Rajesh Krishnan, Ph.D., Associate Director, Merck
Optimizing Early Analytical and Process Development
1:45
Case
Study
What Changes are Permissible between Preparation of Toxicology and Clinical Material?Study
Rapid timelines, often a reality for early development programs, can necessitate project decisions being made in parallel with ongoing development work. One approach early in development is to utilize existing knowledge, as of purification unit operations and formulation stability data, to prepare toxicology material. Later, additional process and product understanding can be leveraged for manufacture of clinical material, with changes supported by comparability studies. The benefits and risks of such a strategy will be discussed.
Christine DeMaria, Ph.D., Senior Scientist, Therapeutic Protein Expression, Genzyme Corporation
2:15
Analytical Support during Development of Antibody-Maytansinoid Conjugates
Several antibody-maytansinoid conjugates are in clinical testing for the treatment of canc/er. In each of these, the drug substance is manufactured by chemically attaching maytansinoid molecules to antibodies through a hetero-bifunctional linker. In early-stage product development several antibody-linker-cytotoxic agent combinations are produced under different process conditions. The analytical assays used in support of testing early-stage products will be discussed.
Michael Fleming, Scientist II, Analytical & Pharmaceutical Sciences, ImmunoGen Inc.
Several antibody-maytansinoid conjugates are in clinical testing for the treatment of canc/er. In each of these, the drug substance is manufactured by chemically attaching maytansinoid molecules to antibodies through a hetero-bifunctional linker. In early-stage product development several antibody-linker-cytotoxic agent combinations are produced under different process conditions. The analytical assays used in support of testing early-stage products will be discussed.
Michael Fleming, Scientist II, Analytical & Pharmaceutical Sciences, ImmunoGen Inc.
2:45
Case
Study
Analytical Comparability Between GMP Lots Manufactured by Different ProcessesStudy
Ensituximab is a therapeutic monoclonal antibody in development to treat GI cancers. The Phase I drug product was manufactured using a perfusion-based cell culture process. A new, high-titer CHO clone was engineered for further clinical testing, and a number of other changes were introduced in the new GMP manufacturing process. This discussion will focus on demonstrating bio-comparability of the Ensituximab drug manufactured by two different processes.
Andrew Bristol, Ph.D., Senior Vice President, Research and Development, Neogenix Oncology, Inc.
3:15
Networking Refreshments, Last Chance for Exhibit and Poster Viewing
4:00
Case
Study
Analytical Strategies for Early Development- the Methods and Assays Needed to Support Non-Clinical and Clinical SuppliesStudy
Upon elevation of a molecule to development, its stability and critical quality attributes are often not well defined. This discussion will provide examples of method development activities performed for early stage projects to establish the key analytical methods to characterize and monitor different attributes such as activity, aggregation, charge heterogeneity and degradation.
Marc Verhagen, Ph.D., Director, Biologics Development, Allergan
4:30
Case
Study
Monitoring of Post-Translational Modifications by Peptide Mapping of Biotherapeutic Proteins in Cell Culture Media SupernatantStudy
The analysis of protein post-translational modifications, such as glycosylation, sialylation and glutamic acid γ-carboxylation currently requires extensive protein purification from cell culture and use of multiple assay platforms. There is a need to rapidly analyze these modifications in cell culture media samples for optimization of production processes. We present a method for the site-specific analysis of protein post-translational modifications in cell culture media samples using targeted peptide mapping with mass spectrometric detection.
Chris Barton, Ph.D., Scientist II, Analytical Biochemistry, MedImmune
5:00
Case
Study
Application of Orthogonal Analytical Methods in mAb Comparability StudyStudy
Manufacturing process changes can result in changes to biological product quality. Comparability studies are typically performed to assess whether these changes are likely to affect product quality, safety and efficacy. This talk presents case studies on how orthogonal biochemical and biophysical methods are utilized in our comparability studies of mAb from different manufacturing processes. The correlation between product quality attributes and process parameters ultimately helps us to understand our manufacturing processes and assists in both upstream and downstream process development and optimization.
Rong-Rong Zhu, Senior Biochemical Scientist, EMD Millipore
5:30
Close of Day Two
8:00
Networking Coffee
8:25
Chairperson's Opening Remarks
Christine DeMaria, Ph.D., Senior Scientist, Therapeutic Protein Expression, Genzyme Corporation
Christine DeMaria, Ph.D., Senior Scientist, Therapeutic Protein Expression, Genzyme Corporation
Implementing Quality by Design for New Development Programs
8:30
Case
Study
Target Product Profiles in Early Development and their Role in Quality by Design and Design SpaceStudy
Generating a quality target product profile (TPP) before initiating product development is an effective way to improve the product quality outcome. Principles of QbD can be used to create a process design that delivers a product meeting the TPP requirements. This approach demands robust analytical methods to accurately measure attributes early in development. This talk will provide examples of effective use of a TPP in early process development.
Susan Dana Jones, Ph.D., Vice President and Senior Consultant, BioProcess Technology Consultants
9:00
Case
Study
Application of Multivariate Analysis to Pharmaceutical Processes: Analogies Between Improving Small Molecule Formulations and Improving Biotherapeutic Product QualityStudy
A methodology is proposed for multivariate analysis (MVA) of cell-level PAT data to identify combinations of process parameters that impact biotherapeutic product quality. A case study for a small molecule process is presented to demonstrate the applicability of the approach. The development of data-rich PAT for biotherapeutic production should enable MVA approaches and may be useful for improving processes, enhancing product quality, and generating fundamental understanding of the process.
Brandon Downey, Research Chemical Engineer, Bend Research, Inc.
Challenge Spotlight
9:30
Case
Study
IND Preparation and Filings in ChinaStudy
This abstract was not available at the time of printing the brochure.
Qian Jia, Ph.D., Chief Scientific Officer, NorthChina Pharm Group R&D Center, China
10:00
Networking Refreshments
Optimizing Transfers in Early Development
10:30
Case
Study
Managing Transfers to Multiple CMOs for a Preclinical Stage Antibody Drug ConjugateStudy
Recent clinical studies have validated antibody-drug-conjugates (ADCs) as a rapidly emerging class of viable therapeutics. While the manufacture of traditional monoclonal antibodies is well established, ADCs require additional processing steps of conjugating a highly potent cytotoxic compound to the antibody, and filling the final drug product. This presentation will focus on the challenges in working with multiple CMOs to handle each of these steps, with an emphasis on logistical issues and timeline management.
Sanjay Patel, Ph.D., Director, Cell Engineering, Takeda San Francisco
11:00
Case
Study
Problem Solving for Processes Transferred to CMOStudy
Once transferred to a CMO, a process can be rapidly assessed for robustness, and problems such as parameters that are close to the edge of failure can be identified. If this is done by DOE, a wealth of information can be obtained about the process and can lead immediately to changes that improve process performance and robustness, designing quality into the process, ensuring that specifications are met and making sure that the process consistently works as required.
Mark J. Wilson, Ph.D., Director, Downstream Process Development, KBI Biopharma, Inc.
11:30
Case
Study
Strategies to De-Risk Downstream Process Technology Transfer and Manufacturing at CMO Site - Early Process Development with Great Flexibility for Upstream Process and Facility ChangesStudy
Through seven years of developing early phase clinical programs and working with a number of well-known CMOs, Ambrx has developed effective strategies to accommodate various risk factors into early PD work to significantly improve the success rate for tech transfer and manufacturing. Using detailed case studies, this presentation demonstrates how a well-designed PD plan can lead to downstream processes with great flexibility and robustness and therefore greatly de-risk the tech transfer and manufacturing at CMO sites.
Yun Bai, Ph.D., Group Leader, Process Development, Ambrx Inc.
12:00
End of Conference
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