Cambridge Healthtech Institute’s Inaugural

Analytical Characterisation of Biotherapeutics
New Formats, New Challenges
6-7 November 2014

With the rapid evolvement of unique and alternative scaffolds (antibody-derived or non-antibody-derived) giving rise to new therapeutic candidates, and the increasing scrutiny from regulatory bodies for higher accuracy and better predictability of immune responses, novel technologies and more advanced techniques for characterizing these molecules are in high demand.

The Analytical Characterization of Biotherapeutics conference highlight the latest developments in analytical tools and technologies to better inform companies on the identity, potency, stability, purity, specificity, yield and the overall biological activity within these molecules. A better informed molecule will bring lower risk, higher developability and a better chance of success at regulatory approval.

Speaker BiographiesDownload Brochure | Register 

Thursday, 6 November

12:30 Conference Registration

13:00 Dessert Break in the Exhibit Hall with Poster Viewing


13:30 Chairperson’s Opening Remarks

Jonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Department of Biochemistry, University of Zurich



13:35 Development of High-Throughput Selection and Screening Methods

Jonas SchaeferJonas V. Schaefer, Ph.D., Head, High-Throughput Laboratory, Department of Biochemistry, University of Zurich

With the help of technology developments, a robust pipeline could be established that already generated valuable DARP in binders (Designed Ankyrin Repeat Proteins, an alternative scaffold), not just covering a variety of different targets but also meeting the high quality criteria important for most scientific projects: monomeric binders that specifically recognize different, non-overlapping epitopes at their targets with high affinities and which can be expressed at high levels in bacterial systems.

14:05 Development of High-Throughput mAb Developability Screening Assays through Detection of Self- and Cross-Interaction

Yingda XuYingda Xu, Associate Director Protein Analytics Adimab

Self- and cross-interaction of an antibody usually leads to developability issues, such as low expression, poor solubility, high viscosity, aggregation and fast serum clearance. Development of high-throughput assays targeting detection of antibody self- and cross-interaction allows elimination of problematic candidates early in the discovery process, minimizing downstream risks.

BIOVIA14:35 Advances in Antibody Characterization and Collaborative Workflows

Anne Goupil, Principal Field Applications Scientist, Pre-Sales, BIOVIA (formerly Accelrys)

Antibody discovery is driven by complex time consuming experimental processes involving numerous teams. Evolving technologies enable researchers to make more informed decisions early in the process. Here we suggest collaborative and comprehensive capabilities in antibody characterization and development: capabilities to analyze annotate, predict 3-dimensional structures, mutation energies for stability and binding affinity, electrostatics properties, aggregation propensity, developability and more. Collaborative environments for registration, workflow and sharing will be discussed.

15:05 Refreshment Break in the Exhibit Hall with Poster Viewing 


15:45 Polysorbate Degradation and Particulates in Biotherapeutic Formulations: Characterization Challenges and Risk Mitigation Strategies

Sandeep Yadav, Ph.D, Scientist, Late Stage Pharmaceutical Development, Genentech, Inc., a member of Roche Group

This presentation will focus on investigating the Polysorbate 20 degradation and subsequent particle formation in biotherapeutics formulation. The results summarizing the challenges around characterizing particles, identifying root cause for Polysorbate degradation, novel methods to quantify degradants and raw material quality as well as the solubility characteristics of the PS20 degradants are discussed.

16:15 Analytical Characterisation of the RNA-Polymerase II inhibitor Amanitin and Amanitin-Based ADCs

Andreas PahlAndreas Pahl, Ph.D., CSO, Heidelberg Pharma

New generations of payloads enter the area of ADC therapeutics including Heidelberg Pharma’s amanitin, a highly effective inhibitor of the eukaryotic RNA Polymerase II. Due to its hydrophilic nature the physicochemical properties differ from well-known tubulin inhibitor based ADCs. This presentation will summarize the current status of Amanitin based ADCs and appropriate methods for their analytical characterisation.

16:45 Characterisation and Comparability Studies for Antibody-Drug Conjugates

Gayathri RatnaswamyGayathri Ratnaswamy, Ph.D., Director, Analytical and Formulation Development, Agensys, Inc.

This presentation will focus on the characterisation of ADCs derived from IgG1 and IgG2 isotypes (derived from hybridoma or CHO cell lines) when conjugated to cytotoxic drugs at the inter-chain disulfides. The results show that the mAb isotypes influence drug loading profiles and this in turn leads to differences in the structure, physico-chemical properties and stability of the resulting conjugates.

17:15 End of Day One

17:15 Dinner Short Course Registration

17:30 – 20:30 Dinner Short Courses

Recommended Short Course*

SC5: Aggregation and Immunogenicity: How Do Formulation, Process and Delivery Influence Immunogenicity of Therapeutic Proteins?

*Separate Registration Required.

Friday, 7 November

08:00 Morning Coffee


08:30 Chairperson’s Remarks

Vivian Lindo, Ph.D., Associate Director, Product Characterisation, MedImmune

08:35 Analytical Strategies for Characterisation of Non-mAbs

Vivian LindoVivian Lindo, Ph.D., Associate Director, Product Characterisation, MedImmune

Case studies of non-mAb characterisation strategies will include:

  • Approaches to primary sequence characterisation
  • Approaches to glycosylation characterisation
  • Higher order structure characterisation for non-mAbs


9:05 Functional Assay Strategies for Bispecific Antibodies and Fusion Proteins

Joerg MoellekenJoerg Moelleken, Ph.D., Senior Scientist, Large Molecule Research, Roche Pharmaceutical Research & Early Development, Roche Innovation Center Penzberg

The increasing complexity of novel biotherapeutics comprising of Bispecific antibodies and fusion proteins raise new challenges for functional characterisation as compared to standard antibodies. Besides addressing new technical aspects like multi-specificity, and poly-valency, additional biological viewpoints like exclusive or simultaneous target binding need to be considered now. This presentation shows points to consider relevant from lead identification until lead characterisation.

09:35 Problem Solving Roundtable Discussions

Specification Setting for ADCs

Gayathri RatnaswamyModerator: Gayathri Ratnaswamy, Ph.D., Director, Analytical and Formulation Development, Agensys, Inc.

1. Specifications for ADCs for Phase 1 versus later stages of development
2. Impact of the ADC specifications on the specifications for the intermediate mAb
3. How to set specifications for related attributes for the ADCs ?

Analytical Characterisation for Product Comparability

DaotianFuModerator: Daotian Fu, Ph.D., Executive Vice President, Livzon Mabpharm
1.    What characterization assays to include for comparability studies at various product development stages
2.    Strategies to set acceptance criteria for process comparability based on historical characterization data
3.    How to differentiate comparability and biosimilarity studies for biosimilar development.

 Comparability for Process Changes throughout Product Lifecycle

Alain BernardModerator: Alain Bernard, Ph.D., Vice President, Technical Operations GPS, UCB Pharma

• When does comparability need to be demonstrated and how?
• What is comparability?
• Can comparability be predicted?
• What if comparability is not achieved?

10:35 Coffee Break

11:00 Developing Quality Product Attributes Using Cell Line Selection Strategies and High-Throughput Analytics

Silke HansenSilke Hansen, Ph.D., Large Molecule Research, Roche Pharmaceutical Research & Early Development, Roche Innovation Center Penzberg

Bispecific antibodies and complex antibody fusion proteins consisting of up to four different polypeptide chains in a single CHO cell line at high quality has been shown to be possible. Diligent cell line selection strategies, supported by high-throughput analytical methods, were keys to the success of identifying cell clones with well characterised cell properties, a stable product profile giving rise to the production of clinical grade API.


11:30 Comprehensive Optimisation of a Single-Chain Variable Domain Antibody Fragment as a Targeting Module for a Cytotoxic Nanoparticle

Kathy ZhangKathy Zhang, M.D., MSc, Scientist, Antibody Technology Team, Merrimack Pharmaceuticals

Antibody-targeted nanoparticles increase the therapeutic index of cytotoxic anti-cancer therapies by directing them to tumour cells. We present a case study of iterative engineering of a single chain variable fragment for use as a targeting arm of a liposome-based cytotoxic nanoparticle. Our studies demonstrate that a comprehensive engineering strategy may be required to develop a scFv with optimal characteristics for nanoparticle targeting.


12:00 Multi-Parametric Optimisation and Characterisation of Antibody Binding Domains for Chronic Dosing

Orla CunninghamOrla Cunningham, Ph.D., Associate Director, Global Biotherapeutic Technologies, Pfizer

Our aim was to generate a tetravalent bispecific molecule targeting two inflammatory mediators for synergistic immune modulation. Phage displayed mutagenesis libraries were aggressively selected and screened using tailored approaches to identify truly potent AND manufacturable scFv-based bispecifics suitable for subcutaneous administration. Subsequent structural analysis revealed how a very restricted number of CDR-based mutations effectively modulated significant changes in potency and stability.

12:30 Enjoy Lunch on Your Own


14:00 Chairperson’s Remarks

HansMartinMuellerHans-Martin Mueller, Ph.D., Director, Bioprocess Development, Merck & Co.

14:05 Comparability for Process Changes throughout Product Lifecycle

Alain BernardAlain Bernard, Ph.D., Vice President, Technical Operations GPS, UCB Pharma

This presentation will describe strategies to implement major process changes during clinical development or after launch of a product on the market. A common denominator to all strategies is to set as an absolute key objective the improvement of product quality. We will illustrate how, a cell line change, or major changes in cell culture media or purification steps can be safely implemented with positive impacts for the patients.

14:35 Analytical and Quality Considerations to Support Product Characterisation Comparability

DaotianFuDaotian Fu, Ph.D., Executive Vice President, Livzon Mabpharm

With wide implementation of QbD in the biotech industry and recent advances in analytical technologies, strategies of analytical characterisation and product comparability continues to evolve. In this presentation, we will discuss implications of QbD applications in process development, and how it may be best used to support process characterisation and product comparability.

15:05 Forced Degradation: A Modern Analytical Tool for Demonstrating Comparability and Similarity

HansMartinMuellerHans-Martin Mueller, Ph.D., Director, Bioprocess Development, Biologics and Vaccines, Merck MSD

Just recently, forced degradation studies became a “super trend” in industry. As an analytical tool, forced degradation studies were applied very successfully to demonstrate comparability of novel biologics and biosimilars. Today, the inclusion of forced degradation studies is just an expectation of regulatory agencies like the FDA when it comes to filing of comparability studies for biologics.

15:35 Product Stability Profiling for Bioprocess Development

Christine P. ChanChristine P. Chan, Ph.D., Principal Scientist/Technical Lead, Global Manufacturing Science & Technology, Genzyme – a SANOFI company

Development of complex glycoproteins requires an array of analytical techniques to adequately understand and control product quality and stability during the bioproduction process as well as storage through the end of shelf-life. This presentation will discuss strategies in product testing and review case studies on characterisation of different proteins in support of process development.

16:05 End of PEGS Europe

Speaker BiographiesDownload Brochure | Register