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

Wednesday, August 14

6:00 - 6:45 am Seaport Fun Run/Walk (Seaport Hotel Plaza Lobby)

7:00  Registration Open and Morning Coffee


Harborview 3

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

Zang_LiLi 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 by Management of Protein Analytics

Feng_JianwenJianwen Feng, PhD, Director, QC-IND of MassBiologics, Umass Medical School

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

Zhang_LeLe 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

10:45 Analytical Method Performance Monitoring – An Integral Part of the Analytical Method Lifecycle

Liu_Dan_CassieDan (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

Carpy_AlejandroAlejandro 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.

IDBS 11:45 Presentation to be Announced

Abhay Kini, Director, Product Management, Marketing, IDBS

AdvancedInstruments 12:15 Luncheon Presentation: Osmolality as an Indicator of Process Deviations

Wright_KristeenaKristeena Wright, PhD, Application Scientist, Advanced Instruments

Bioprocessing workflows require close monitoring of critical quality attributes to produce biologics of optimal quality. Osmolality is one solution property that can be informative at all stages of bioproduction. This presentation will demonstrate the value of osmolality testing using the newest OsmoTECH line of freezing point osmometers designed for biotherapeutic development. From media preparation to purification and formulation, osmolality is an informative parameter that can be easily measured using our robust systems.

1:00 Dessert Break in the Exhibit Hall with Poster Viewing


Harborview 3

1:45 Chairperson’s Remarks

Elena Smith, PhD, Deputy Director, Quality Control, Sanofi Pasteur

1:50 Automated Sample Preparation Workflow for Novel Biotherapeutics Characterization

Wang_YunanYunan 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

Meiyappan_MuthuMuthuraman (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

McCoy_MarkMark 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

Oruganti_PrasadPrasad 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

4:45 Plenary Keynote Session View details

6:00 A Taste of New England Reception in the Exhibit Hall with Poster Viewing

7:00 End of Day

Thursday, August 15

6:00 - 6:45 am am Namaste@#BPSMT (Seaport Hotel Plaza Lobby)

8:00  Registration Open and Morning Coffee


Harborview 3

8:25 Chairperson’s Remarks

Jianwen Feng, PhD, Director, QC-IND of MassBiologics, Umass Medical School

8:30 Representative Small-Scale Purification Workflows Supporting mAb Process Development

Bryngelson_PeterPeter 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

Bahrainwala_TasneemTasneem 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

Gebler_JohnJohn 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


Harborview 3

10:45 Potency Assays for AAV Gene Therapies

Cheung_WinWin-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

Smith_ElenaElena 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

Dubey_SachinSachin 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

1:55 End of Conference