Cambridge Healthtech Institute’s Second Annual

Detection, Characterization and Control of Impurities in Biologics

Hot Topics, Emerging Contaminants and Impurities, Case Studies and New Technologies

August 15-16, 2019


CHI's 2nd Annual Detection, Characterization and Control of Impurities in Biologics conference will bring together leading experts to discuss hot topics, emerging contaminants and impurities and new characterization tools for impurities that may come from various sources and stages of product development. Through new presentations, informative panel discussions, high-level poster presentations, and interactive breakout discussions, top scientists will share new insights into characterization and control of various impurities. Some of the hot topics for this year will be new and novel technologies for virus and pathogen detection, host cell proteins, lipases and enzymatic degradation, aggregations, leachable, chemistry and manufacturing controls (CMC) strategy for regulatory filings.

Final Agenda


Waterfront 1C

6:00-8:30 Recommended Pre-Conference Dinner Short Course* [Dinner  will be served]

SC9: Impact of Impurities on Stability of Biologics - Detailed Agenda


Diane Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc.

Katherine E. Bowers, PhD, Principal Scientist, Group Leader, Fujifilm Diosynth Biotechnologies

Impurities in protein therapeutics can originate from a variety of unexpected sources. As the protein molecule is taken through the upstream/downstream processes, final product manufacturing (fill/finish) and even during patient delivery, there is a myriad of potential “hidden” impurities that can have an impact to the safety and efficacy of the bio-therapeutic. This course aims to answer the questions of what and where are the greatest risks for biologic impurities and how can we study the impact of these impurities on the protein molecule. Our mission is to collectively discuss how to identify, evaluate and mitigate impurity risks from early development and throughout the product life cycle.

Thursday, August 15

11:30 am Registration Open

12:15 pm Enjoy Lunch on Your Own

1:15 Ice Cream Social in the Exhibit Hall with Last Chance for Poster Viewing 


Harborview 3

1:55 Chairperson’s Remarks

Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia

2:00 KEYNOTE PRESENTATION: USP Standards for Monitoring Product-Related and Process-Related Impurities in Biologics

McCarthy_DianeDiane McCarthy, PhD, Senior Manager, Science and Standards Biologics Pipeline Development, Global Biologics, US Pharmacopeia

The complexity of biotherapeutic products and manufacturing processes can yield a variety of impurities, including process-related impurities, such as host cell protein, host cell DNA and particulates, and product-related impurities, such as precursors, aggregates and degradation products. This presentation will provide an overview of approaches for monitoring impurities, including specific examples that leverage USP standards, as well as an update on new USP standards to support impurity testing.

2:45 Mitigating Uncertain Times: Challenges with Rapid Detection and Characterization of Biological and Chemical Threats and Accelerated Development of Pharmaceutical Countermeasures for Unanticipated Medical Needs

Kiehl__DouglasDouglas E. Kiehl, MSc, Research Advisor, Bioproduct, Research & Development, Eli Lily and Company

Potentially catastrophic chemical and biological threats represent deliberate or unintentional actions placing civilian and military personnel at considerable risk. Rapid response requires novel approaches for detection and characterization of chemical and pathogenic biological impurities and effective deployment of life-saving countermeasures with acceptable benefit/risk ratio. Challenges include the development of robust, portable technologies for rapid and reliable threat identification, processes for development, manufacture, review/approval and deployment of countermeasures, and supply chain integrity.


Harborview 3

3:15 Analytical Strategies for Characterizing Residuals in Autologous Chimeric Antigen Receptor (CAR) T-Cell Therapy

Yue_HaiHai Yue, PhD, Senior Scientist, Analytical Development, Juno Therapeutics, A Celgene Company

The manufacturing of autologous CAR T-cell products starts with highly heterogeneous leukapheresis materials from patients and involves the use of various raw materials. This complex process may result in a formulation containing process- and product-related residuals. A phase-appropriate, risk-based analytical development strategy for possible residual characterization will be presented.

3:45 Gene Therapies: Lessons Learned from Viral Clearance Studies

Iheanacho_AkunnaAkunna Iheanacho, PhD, Director of Research & Development, Texcell – North America

The manufacturing of Developing a robust viral clearance program requires a careful assessment of risk and a thorough understanding of the manufacturing process used to develop the biopharmaceutical product. In this presentation, case studies will be used to highlight some strategies employed to evaluate viral clearance in a gene therapy setting.

4:00 Refreshment Break

4:15 Impurity Identification and Characterization – A Regulatory Approach

Galindo_KatherineKatherine Galindo, Senior Manager Regulatory Affairs, TESARO, Inc.

As the industry expands beyond standard small molecule and monoclonal antibody products, regulatory agencies are taking different approached to their expectations around impurities. Novel products, such as RNA and gene therapy vectors do not fit the mold of precedent set in the biologics field. In this presentation, we will review guidance and case studies around regulatory controls of impurities and how they vary for new technologies.

4:45 PANEL DISCUSSION: Guidelines, Risk Assessment and Management of Impurities in New and Complex Biologics

Moderator: Diane Paskiet, MS, Director, Scientific Affairs, Scientific Affairs and Technical Services, West Pharmaceutical Services


Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia

Akunna Iheanacho, PhD, Director, Research & Development, Texcell –North America

Hai Yue, PhD, Senior Scientist, Analytical Development, Juno Therapeutics, A Celgene Company

Katherine Galindo, Senior Manager Regulatory Affairs, TESARO, Inc.

Friday, August 16

7:30 am Registration Open

7:30 Small-Group Breakout Discussions with Continental Breakfast

This session provides the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges.


Harborview 3

8:30 Chairperson’s Remarks

David Cetlin, Founder & CEO, MockV Solutions LLC

8:35 Aseptic Processing Challenges for Biologics

Jen Juneau, Principal Scientist, Pharmaceutical Research and Development, Pfizer, Inc.

9:05 Second Generation Reference Materials for Adventitious Virus Detection by Metagenomics

Mee_EdwardEdward Mee, DPhil, Senior Scientist, Live Viral Vaccines, Virology, National Institute for Biological Standards and Control

Metagenomics offers great potential for improved adventitious virus screening; however, many practical challenges exist, including cost, complexity and the difficulty in defining limits of detection for unknown viruses. Well-characterized reference materials containing representative virus genome, capsid and envelope structures will enable meaningful inter-laboratory comparisons, support method development and act as process run controls.

9:35 The Use of a Non-Infectious Minute Virus of Mice Surrogate to Predict Viral Clearance during Downstream Applications

Kevin Herbig, BS, Scientist, Biopharmaceutical Technology, GSK

Viral clearance studies are expensive and logistically challenging. A BSL-1 compatible, non-infectious Minute Virus of Mice surrogate was used to predict virus removal via nanofiltration and chromatography. The results from several studies are presented here including High Throughput Screening, DOE and HIC data sets. Overall, the non-infectious particle was shown to accurately predict MVM clearance and can be used as an economic process development tool.

10:05 Networking Coffee Break


Harborview 3

10:30 Improvements in Risk Management Through Better Characterization of Fetal Bovine Serum

Curry_RobertRobert C Curry, MBA, Director, International Serum Industry Association

A review of how the International Serum Industry Association (ISIA) is vastly reducing the risk of serum adulteration and contamination through its traceability program, animal origin, and age testing, and gamma irradiation of serum.

11:00 Host Cell Protein Characterization by LCMS

Jiang_GuifengGuifeng Jiang, PhD, Senior Manager, Analytical Science, Boehringer-Ingelheim, USA

Host cell protein (HCP) impurities need to be controlled and monitored for product safety, efficacy and quality. Although HCPs are typically measured by ELISA, these methods have significant limitations for HCP analysis. Orthogonal proteomic LCMS methods have become hot topics due to the capability of identifying and quantifying individual HCP species. We will discuss our development of sensitive and quantitative analytical LCMS methods for HCP identification and quantitation.

11:30 Generating Data to Support the Understanding of Manufacturability of Monoclonal Antibodies

Michael_AnyadiegwuMichael Anyadiegwu, PhD, Senior Scientist, Downstream Processing, Centre for Process Innovation Ltd., National Biologics Manufacturing Centre

A short list of 50 monoclonal antibody sequences was selected based on experimental data from a long list of 200 monoclonal antibodies sequences. These 50 molecules covered a range of titres and quality attributes, were produced and purified using standard CHO, USP and DSP platforms. This presentation reviews upstream, downstream, analytic and immunogenicity data linking the biochemical and quality properties of the antibody variants to sequence and structural liabilities.

12:00 pm Enjoy Lunch on Your Own

1:15 Session Break


Harborview 3

1:25 Chairperson’s Remarks

Guifeng Jiang, PhD, Senior Manager, Analytical Science, Boehringer-Ingelheim, USA

1:30 Characterization of HCPs in the Downstream Processing

Li_RongRong Li , PhD, Associate Director, Sanofi Genzyme

Various impurities are encountered during the downstream processing of the biologics. Host cell protein (HCPs) need to be monitored for product safety, efficacy, and quality. In this presentation, we will discuss the analytical characterization and control of host cell protein (HCP) impurities.


Harborview 3

2:00 Factors Influencing Polysorbate’s Sensitivity Against Enzymatic Hydrolysis and Oxidative Degradation

Kranz_WendelinWendelin Kranz, MSc, Scientist LC-MS, Coriolis Pharma Research GmbH

Polysorbate (PS) degradation is a hot topic for the pharmaceutical development of biologics. We compared the sensitivity of different grades of PS20 and PS80 against enzymatic hydrolysis and oxidative degradation. Systematic degradation studies with multi-compendial PS20 and PS80, as well as all-laurate PS20 and all-oleate PS80 (compliant to Chinese Pharmacopoeia) will be presented, as well as a novel fast LC-CAD method to differentiate between hydrolytic and oxidative PS degradation.

2:30 Molecular Interactions between Drug Product Formulation Excipients and Infusion Containers

Dilrukshan_KashmiraKashmira Dilrukshan, Associate Research Scientist, Drug Product Science Technology, Bristol-Myers Squibb

At the point of intravenous dosing, most biologics are typically diluted with diluents such as saline and dextrose in infusion containers. These are manufactured with a plasticized polymer. These additive polymers lend flexibility and durability to the containers. The objective here was to measure and quantify the amount of plasticizers leaching from IV bags containing various infusion formulation compositions under several use-time conditions.

3:00 Understanding Polysorbate Degradation Due to Process Impurities: Rates and Mechanisms and Their Impact on Stability

O’Brien_ChristopherChristopher O’Brien, PhD, Process Engineer III, Process Science, Sanofi

Different mechanisms and rates associated with polysorbate degradation pathways were evaluated. A mechanistic model was developed that links polysorbate degradation rate to process impurities. The understanding gained from the model was used to support process improvements.

3:30 Close of Conference