Analytical Support for Drug Product Development


Advances in protein science, drug combinations, delivery technology and analytical methods are supporting an unprecedented wave in novelty in the design of biologic drug products. With these new products comes the urgent need for analytical support of product development, regulatory filings and manufacturing – in ways that require a constant adaptation by analytical and formulation groups to new modalities and technologies. New for 2019, the PEGS Analytical Support for Drug Product Development provides a best practices exchange for scientists now working to develop these new products – or for those wishing to be prepared for forthcoming programs in their organization’s pipelines.

Final Agenda


12:00 pm Registration (Commonwealth Hall)

12:35 Luncheon in the Exhibit Hall with Poster Viewing (Commonwealth Hall)


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1:40 Chairperson’s Opening Remarks

Vijay Dhawan, PhD, Associate Director, Analytical Development, Sanofi

1:50 Developability Evaluation: Right Tools at the Right Time?

Stach_LasseLasse Stach, Investigator, Drug Design and Selection, GlaxoSmithKline, United Kingdom

The talk will focus on the interface between discovery and development, timing of the various developability studies and deployment of the available tools. Early lead selection of biotherapeutics requires meticulous assessment of a variety of molecule properties to minimize risk during development. However, increased complexity of non-standard protein formats requires an adaptation from former platform-based screening to project specific strategies to select quality candidates.

2:20 Approaches to Optimizing Manufacturability of Monoclonal Antibodies

Anyadiegwu_MichaelMichael Anyadiegwu, PhD, Senior Scientist, Downstream Processing, Center for Process Innovation, National Biologics Manufacturing Center, United Kingdom

Molecules can fail to transition from discovery to commercialisation due to developability issues such as instability, aggregation etc. A collaborative project set out to systematically explore the developability landscape of monoclonal antibodies using experimental data. Sequences were expressed and purified allowing datasets of biochemical and biophysical quality attributes to be generated. These were then evaluated to understand more about the potential to critically assess monoclonal antibody sequences early in development.

2:50 KEYNOTE PRESENTATION: Design and Analytical Challenges of In Use Stability Studies for Biologics

Wils_PierrePierre Wils, PhD, Head, Biologics Formulation and Process Development, Sanofi, France

The early clinical development of highly potent biologics is usually performed by intravenous administration requiring very low starting doses and wide dose ranging. We will present case studies about in use stability studies, related to the quantification of biologics in very dilute solutions, and means to minimize protein adsorption onto the infusion material. We will also discuss trends in the preparation of infusion solutions in hospital settings.

3:20 A Platform Technology for the Rapid Generation Of Robust Anti-Idiotypic Binders for Clinical PK Assays

Johnson_MattMatt Johnson, CTO, Avacta Life Sciences

Affimer proteins are next-generation affinity scaffolds with great potential for the generation of both novel biotherapeutics and research tools. It is possible to generate highly-specific anti-idiotypic Affimer binders using a 14-week development process. In comparison to commercially available anti-idiotypic Fab fragments we have shown it is possible to develop high-performing antibody PK assays (and ligand binding assays) in complex samples using only a single, specific capture Affimer and generic antibody detection minimising assay complexity.

3:50 Networking Refreshment Break (Harbor & Mezzanine Level)

4:20 Method Development and Characterization of Product Specific Host Cell Proteins

Kessler_JenniferJennifer Kessler, Senior Development Associate, MacroGenics, Inc.

Monoclonal antibodies and bispecific DART® molecules are being developed for a variety of indications including immune-oncology. These biopharmaceuticals contain residual host cell proteins (HCPs) from production cell lines that can pose a risk to product safety and stability. This presentation will discuss the development of process specific HCP methods and the characterization of product specific HCPs using this novel class of molecules and other antibody molecules as case studies.

4:50 Phase Appropriate Potency Assays: What Is Needed and When?

Magil_SheilaSheila G. Magil, PhD, Principal Consultant, BioProcess Technology Consultants, Inc.

Regulatory expectations for potency assays include their being related to the mode of action in vivo. There are many ways to measure potency and what method is best also depends on the phase of development. This presentation will describe approaches to the development of acceptable potency assays throughout development including when and how to validate potency assays.

5:20 End of Day

5:20 Registration for Dinner Short Courses (Commonwealth Hall)

Recommended Dinner Short Course*

SC14: Subvisible Protein Particles in Immunogenicity: Measurement, Characterization and Impact - Detailed Agenda

Björn Boll, PhD, Head, Particle Lab and Higher Order Structure Protein Analytics, Physical Chemical Analytics, Novartis Pharma AG

Antonio Iglesias, PhD, Expert Scientist, Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche, Ltd. Basel


*Separate registration required.


8:00 am Morning Coffee (Harbor Level)


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8:30 Chairperson’s Remarks

Gerald Gellermann, PhD, Senior Fellow, Novartis, Switzerland

8:35 Dual mAb Therapies: Co-Administration and Co-Formulation Challenges and Solutions

Lin_JasperJasper Lin, PhD, Scientist and Group Leader, Genentech

Recently, there has been a surge of clinical trials using multiple mAbs to bring about synergistic efficacy. Sequential IV administration is burdensome for the patient, leading to interest in developing CMC solutions by means of co-administration and fixed dose combinations (FDCs). FDCs provide a great deal of promise, but also present new challenges. This talk will highlight formulation, process, and analytical challenges accompanying the development of co-administration and co-formulation strategies.

9:05 Tools for Developing a Mechanistic Understanding of Specificity in Post-Translational Modification Targeting Antibodies

Cho_YongkuYongku Cho, PhD, Assistant Professor, Chemical and Biomolecular Engineering, University of Connecticut

Validation of antibody specificity is critical for biotherapeutics development. In particular, antibodies targeting site-specific post-translational modifications (PTMs) require utmost specificity, due to their heterogeneous and transient nature. However, recent validation efforts reveal an alarming lack of specificity in PTM-targeting antibodies. This presentation will showcase our recent efforts to overcome this problem, by understanding the origin of specificity and applying protein engineering strategies to improve specificity.

9:35 NEW: Selected Poster Presentation: High-Throughput Characterization of Residual Hydrogen Peroxide in Drug Product

Castellanos_Maria_MonicaMaria Monica Castellanos, Ph.D., Scientist, GSK Vaccines

10:05 Networking Coffee Break (Commonwealth Hall)

10:35 Bridging Discovery and Development by Early Developability Assessment

Chai_QingQing Chai, PhD, Principal Research Scientist, Protein BioSciences, Eli Lilly & Co.

Biopharmaceutical development is often challenging. Among those challenges is antibody “developability,” such as solubility, viscosity, manufacturability, and formulation suitability. Multidimensional developability assessment platform, including analytical methods coupled with computational approaches, was established and utilized to perform high-throughput screening at early discovery stage to facilitate the discovery, selection, and optimization of the most promising mAb molecules. Here we discuss case studies on improving mAb developability applying the principal of Quality by Design at discovery stage.

11:05 IV Set Compatibility Studies for ADCs

Zaitsev_AlexandraAlexandra (Sasha) Zaitsev, Development Associate, Analytical & Pharmaceutical Sciences, ImmunoGen

Compatibility studies with administration sets of the drug product are performed during early stage development to determine the propensity of the antibody-drug conjugate (ADC) to become altered upon contact with the infusion set materials. Possible alterations include adsorption to the infusion set, aggregation, particulate formation, etc. This presentation will discuss challenges associated with study set up and interpretation of the acquired data.

11:35 Device Considerations in Drug Product Development – Case Study of Ophthalmic Injections of Anti-VEGF Therapies

Dounce_SusanSusan Dounce, PhD, Principal SME, Prefilled Syringes, West Pharmaceutical Services

Frequent Injections into the eye can introduce particulate matter or biologic contaminants that can lead to inflammation, infection, floaters in the vision or vision loss. It is therefore critical to understand how the delivery device itself can impact the safety of the drug product so that the proper material selections are made for primary packaging to maximize patient safety. In this talk, we will explore the critical device considerations for ophthalmic drug delivery.

12:05 pm Oligomericity Status Changes and its Effects on the Stability of Proteins in Solution

Bommarius_BettinaBettina Bommarius, PhD, Senior Research Scientist, Chemical and Biomolecular Engineering, Georgia Institute of Technology

We have investigated protein activity and stability as a function of the oligomeric status of a protein. Our results indicate that activity and stability correlate with a uniform oligomeric presence and that the proteins investigated can exist as a mixture of different oligomers and aggregates. Factors that influence the percentages of each given oligomer/aggregate will be presented as well as effects of oligomeric mixtures on specific activities. Protein oligomericity is an underappreciated link between protein concentration and its activity or stability.

12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:05 Networking Refreshment Break (Harbor & Mezzanine Level)


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1:35 Chairperson’s Remarks

Abbie Esterman, PhD, Senior Scientist, Methods and Analytical Development, Bristol-Myers Squibb

1:40 Method Bridging: Fit or Mis-fit

Esterman_AbbieAbbie Esterman, PhD, Senior Scientist, Methods and Analytical Development, Bristol-Myers Squibb

Technologies used for release and stability testing of biologics are rapidly evolving to meet the ever-increasing challenges in drug development. Consequently, one or more analytical methods will need amendment during the product life cycle. Before new methods can be filed, bridging studies are required to establish comparability and confirm the new method is fit for its intended use. Two case studies bridging novel and conventional methods for purity and charge heterogeneity analyses will be examined.

2:10 Strategies for Comparability Testing to Support Process/Product or Manufacturing Site Changes

Dhawan_VijayVijay Dhawan, PhD, Associate Director, Analytical Development, Sanofi

Accelerated timelines for clinical programs and an increased reliance on external contract manufacturers during the different project stages have resulted in an increased need to perform analytical comparability to support use of the post-change material in the clinic while avoiding non-clinical or clinical bridging studies. Approaches for establishing and executing analytical comparability plans will be discussed during the presentation.


2:40 Development of Process and Product Understanding: Use of Prior Knowledge and Challenges for Setting of Specifications

Gellermann_GeraldGerald Gellermann, PhD, Senior Fellow, Novartis, Switzerland

Applications for design space are rare as the risk benefit of a full QbD application is not clear and QbD based applications usually receive more scrutiny than traditional once. In this presentation, we will discuss the use of prior knowledge and compare consequences on specifications setting and process parameter criticality for the different development approaches.

3:10 Theoretical Constraints on Design Space for High Concentration Filling: Minimizing Clogging and Increasing Filling Precision

Galas_RichardRichard Galas, PhD, Senior Scientist, Takeda

The fluid properties of many biologic formulations designed for pre-filled syringes are unique and create engineering challenges for filling systems. These products often clog the filling lines, causing costly delays while components are replaced. A theoretical fluid mechanics approach to the filling process was taken to define key parameters that impact filling accuracy and clogging. This approach identified a theoretical design space that minimizes filling variability and clogging.

3:40 End of Conference

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