Cambridge Healthtech Institute’s 6th Annual
Accelerating Analytical Development
Optimizing the Speed and Efficiency of Key Analytical Steps in Biotherapeutic Development
August 14-15, 2019
Research for this meeting revealed that industry analytical groups are facing increased pressure to deliver key analytical studies used in candidate selection, process development, clinical development and regulatory submissions faster than ever before
– and at lower costs. Accelerating Analytical Development offers a best practices forum in which industry scientists and managers can exchange ideas on strategies, new technologies and the integration of analytical methods in support of these
goals. The conference will address the most important roles of the analytical function at every stage of development and provide insights on how different organizations are addressing these challenges.
Final Agenda
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Wednesday, August 14
7:00 am Registration Open and Morning Coffee
8:05 Chairperson’s Remarks
Alejandro Carpy, PhD, Senior Scientist, Large Molecule Research, Roche Diagnostics GmbH, Germany
8:15 KEYNOTE PRESENTATION: Accelerating Analytical Development: Thoughts on Driving Force and Strategy
Li Zang, PhD, Director,
Protein Analytics, AbbVie
Accelerating pharmaceutical program development from discovery to commercialization has been repeatedly discussed across the industry. This talk will review the potential opportunities in achieving accelerated pharmaceutical program development through
early developability and manufacturability assessment, application of prior knowledge in efficient development planning; utilization of high-throughput assays and automation as well as advanced analytical technologies to gain understanding and control
of potential product quality liabilities.
9:00 Accelerating Antibody Drug Development from Discovery to IND
Jianwen
Feng, PhD, Senior Principal Scientist, Head, Protein Analytics, Jounce Therapeutics
Biological drug development is a long and costly process. On average it takes 3 to 7 years from discovery to IND. Many efforts have been made to accelerate development and reduce resource expended on candidate development. Jounce has developed a process
to speed up development in 2-2.5 years by adopting a platform-driven antibody development process that evaluates both developability and manufacturability simultaneously as well as introduces cell line development before DC selection.
9:30 Implementation of a Multi-Attribute Method for Product Release and Stability Testing of a Fc Fusion Protein
Le Zhang, PhD, Senior
Scientist, Amgen
A multi-attribute method (MAM) has been developed for a Fc fusion protein for release and stability. The critical attributes monitored by MAM include sialylation, oxidation, deamidation and clips selected from PQAA process. Characterization of traditional
methods including CEX and rCE-SDS and comparison with MAM demonstrate excellent correlation for monitoring charge variants and clips. We will also discuss engagement with regulatory agencies to advance MAM technology to replace traditional methods.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)
10:45 Analytical Method Performance Monitoring – An Integral Part of the Analytical Method Lifecycle
Dan (Cassie) Liu, Statistician, Bristol-Myers Squibb
Method performance monitoring is a critical part in analytical method lifecycle. Routine monitoring of the key method parameters provides reliable understanding of the long-term method performance, proactively identifies method performance variations
to ensure the method remains fit for intended purpose and provides meaningful assessment of product quality and related investigations. This talk will provide an overview of the key aspects of analytical method performance monitoring and share
some real-life examples.
11:15 Fast pCQA Assessment of Next-Generation TCBs
Alejandro Carpy, PhD, Senior Scientist, Large Molecule Research, Roche Diagnostics GmbH, Germany
T-cell bispecifics (TCBs) are an innovative method of harnessing the immune system to fight cancer tumors. The TCB antibody is equipped with structural features that promote tumor targeting and retention, resulting in a robust, antitumor effect. TCBs
required in-depth assessment for correct pCQA (potential critical quality attribute) characterization. We present an approach for assay development to support characterization of pCQAs during Analytical Development.
3:35 Presentation to be Announced
12:00 pm Sponsored Presentation (Opportunity Available)
12:15 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:00 Session Break
1:45 Chairperson’s Remarks
Elena Smith, PhD, Deputy Director, Quality Control, Sanofi Pasteur
1:50 Automated Sample Preparation Workflow for Novel Biotherapeutics Characterization
Yunan Wang,
PhD, Scientist, Amgen
Therapeutic proteins are the fastest growing area as drug substance. At the early development stage, novel engineered protein therapeutics with increasing complexity such as fusion proteins are potentially susceptible to proteolytic enzymes in-vivo,
which could affect the pharmacokinetic profile. In this showcase, we integrated the AssayMap Bravo automated sample purification system with CE-LIF and CE-MS to study the protein therapeutics stability to guide the lead molecule design and selection
efficiency.
2:20 Biophysical Screening Methods for Candidate Selection
Muthuraman (Muthu) Meiyappan, Head, Analytical Research, Discovery Therapeutics, Takeda Pharmaceutical Company Ltd.
Biologics molecular selection “by-design” for developability is gaining increased attention in recent years driven by advances in high-throughput analytical instrumentation. Molecular properties for developability are generally evaluated
for purified samples which limits throughput of candidate selection in the discovery phase. Here I present some high-throughput biophysical screening approaches, with less stringent sample requirements, to select or monitor a molecule/clone with
a specific property that can also be transferrable for later development stages.
2:50 Solution NMR Assessments of Therapeutic Peptide and Protein Behavior
Mark McCoy,
PhD, Principal Scientist, Merck
Solution NMR spectroscopy provides detailed assessments of therapeutic peptide and protein behavior. Structural fingerprints capture solution structure, conformation and probe for site-specific interactions. Diffusion profiling and dynamics measurements
are used to understand self-association, multimer assembly, aggregation and the impact of sequence and formulation on molecular motions. Applications to HOS characterization, developability, high concentration formulation, co-formulations will
be discussed. Discovery and development applications will be presented.
3:20 Implementation and Challenges of Integrating a New Platform into Analytical and Formulation Workflows
Prasad Oruganti, PhD, Scientific Leader, Biopharm Product Sciences, Biopharm R&D, GlaxoSmithKline
Screening for formulations that impart optimal stability to biopharmaceuticals is time consuming and takes enormous effort. Use of automation and design of experiments can reduce the effort involved in this process. This presentation describes the
integration of the Freeslate automated system into our formulation development workflows at GSK, perspectives on its implementation, and challenges that were overcome.
3:50 Refreshment Break in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)
4:45 Plenary Keynote Session View details
6:00 A Taste of New England Reception in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)
7:00 End of Day
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Thursday, August 15
8:00 am Registration Open and Morning Coffee
8:25 Chairperson’s Remarks
Jianwen Feng, PhD, Senior Principal Scientist, Head of Protein Analytics, Jounce Therapeutics
8:30 Representative Small-Scale Purification Workflows Supporting mAb Process Development
Peter Bryngelson, PhD, Senior Scientist, Analytical Development, Biogen
Assessment of product quality attributes is critical to the development of therapeutic proteins. Our goal is to perform a one-step Protein A purification that is representative of a commercial process so that upstream development decisions are
made using a relevant downstream process. Here we discuss our workflow evolution from chromatography to plate-based to parallel chromatography.
9:00 Characterization of Novel Antibody-Based Biotherapeutics by Liquid Chromatography Coupled with Mass Spectrometry
Tasneem Bahrainwala, PhD, Group Leader, Analytical Sciences Mass Spectrometry, MacroGenics, Inc.
Monoclonal antibodies and novel bispecific DART® molecules are being developed for a variety of indications including immune-oncology. Sensitive, accurate and high-throughput analytical techniques including liquid chromatography, coupled with
mass spectrometry (LC-MS) play a pivotal role in the characterization and development of these molecules. This presentation will discuss case studies showing molecular characterization of novel antibody-based molecules using LC-MS.
9:30 Enabling Routine and Reproducible Biotherapeutic Analysis When Data Integrity Matters
John Gebler, PhD, Director, Waters Corporation
Driven by increasing industry demand for a robust accurate mass MS system for routine biotherapeutic analysis within the process, development and quality organizations, a new small footprint bench-top LC-MS system was purposefully designed
and developed to offer simplified operational modes, and optimized automation with accurate and reproducible mass measurements for proteins, peptides and released glycans. In this work, we show specific examples of deploying this compliance-ready
bench-top system in late stage development of biotherapeutics.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)
10:45 Potency Assays for AAV Gene Therapies
Win-Den
Cheung, PhD, Associate Director, Analytical Development, Regenxbio
For AAV gene therapies for rare diseases, early clinical success can lead to expedited product development and a pathway for accelerated approval. We present a relative infectivity assay which, unlike TCID50, can measure small differences
in AAV vector infectivity related to potency. The relative infectivity assay is a useful tool for early development and allows time for a potency assay supporting licensure to be developed and matured alongside the product.
11:15 Revolution Over Evolution: Emerging Technologies Require Alternative Analytical Methods and Not Adaptation of Traditional
Elena Smith, PhD, Deputy Director, Quality Control, Sanofi Pasteur
Regulations and guidance, developed and optimized for traditional products, may need adjustment when applied to novel innovative and often fundamentally different products. Instead of adaptation of traditional analytical methods for the new
generation products, alternative analytical approach (alternative potency assay or alternative reference material) must be considered as a first choice based on scientific rationale of emerging technology.
11:45 Contrasting Analytical Method Development for High and Low Concentration Biopharmaceuticals
Sachin Dubey, PhD, Head, Formulation, Analytical and Drug Product Development, Glenmark Pharmaceuticals SA, Switzerland
Concentration range of marketed (and under-development) biologics ranges from low µg/mL to a couple of hundred mg/mL. This wide range unwraps challenges of extremes for analytical development – on one end high concentration compositions
throw challenges related to viscosity, sample handling, stability etc. On the other end extremely low concentration unravels analytical challenges related to – overcoming interference, sensitivity, adsorption etc. Clinical phase
appropriate analytical strategy for the two cases is essential.
12:15 pm Enjoy Lunch on Your Own
1:15 Refreshment Break in the Exhibit Hall with Last Chance for Poster Viewing (Sponsorship Opportunity Available)
1:55 End of Conference
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