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Optimizing Biologics Formulation Development


This annual meeting covers the latest trends and challenges in biologics formulation with a focus on improving time to market via early formulations and characterization and overcoming challenges in stability. It features in-depth case studies and interactive discussions on early formulations and characterization, screening, overcoming aggregation challenges, utilizing enabling analytical methodologies, managing tech transfer challenges, and use of experimental design and high-throughput principles.

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MONDAY, JANUARY 9

7:30 am Conference Registration and Morning Coffee

 

OPTIMIZATION OF FORMULATION DEVELOPMENT FOR BIOLOGICS

8:55 Chairperson's Opening Remarks
Simon Webster, Avacta


» KEYNOTE PRESENTATIONS

9:10 Increasing Formulation Knowledge Space Leveraging Automation

Jamie Moore, Ph.D., Associate Director and Senior Scientist, Early Stage Pharmaceutical Development, Genentech

It is becoming common practice in industry to use platform approaches to support pre-clinical and Phase I clinical studies to reduce up-front investment for early process and product development. The drawback of platforms is the limited knowledge space. To increase formulation knowledge, we have developed high-throughput systems that span a wide range of conditions but require minimal resources and material. This data provides the foundation for commercial formulation development.

9:45 Stabilization and Formulation of Therapeutic Proteins: The Container is Part of the Formulation

Theodore W. Randolph, Ph.D., Gillespie Professor of Bioengineering, Department of Chemical and Biological Engineering, University of Colorado, Boulder

 

10:20 Networking Coffee Break

10:45 Formulation Challenges During Vaccine Development

Dominique Lemoine, Ph.D., Director and Head, Formulation Development, Research & Development, GSK Biologicals

The specificity of vaccine formulations is linked to the diversity of antigens, the multivalent matrix and the combination with Adjuvant Systems. Vaccine products are distributed worldwide and may be administered to healthy newborns. For the formulators, this constitutes exciting challenges - case-by-case formulation development, complex analytical tools, and physico-chemical incompatibilities as well as a requirement for an exclusive use of GRAS excipients and product stability upon worldwide transportation. These challenges highlight how important formulation is for the success of vaccines and give the opportunity for applying improved technologies. 

11:15 Improving Vaccine Development:  Empirical Approaches versus Rational Design

Manmohan Singh, Ph.D., Global Head, Vaccine Formulation Science, Novartis Vaccines

11:45 Considerations for Formulating Stable Antibody-Maytansinoid Conjugate Products

Lizz Bartlett, Ph.D., Head, Analytical and Pharmaceutical Sciences, ImmunoGen

The talk will center on the complex nature of antibody conjugates and how this influences formulation decisions. The audience will gain a better understanding of the complexities involved in formulating these combinations of antibody and small molecule products.

12:15 pm Close of Morning Session


          Sponsored by
Pall_LifeSciences
12:30 Luncheon Presentation I:
High Throughput, Multi-Mode Biophysical Measurements for Enhanced Candidate Screening and Formulation Development
Simon Webster, Ph.D., Chief Scientific Officer, Avacta Analytical
The presentation will highlight the advantages of applying multiple biophysical analytical techniques to the investigation of protein stability. This multi-modal analytical approach, when combined with the capability for rapid, high-throughput measurements from small sample volumes, provides a powerful tool for biopharmaceutical development. Applications include screening candidate molecules for ‘developability’, screening formulations and for elucidating aggregation mechanisms. Example data generated by the authors will be presented together with a number of examples from the literature where multi-modal biophysical data has been used to good effect in biopharmaceutical development. Examples include improving predictions of long term storage stability, improving downstream processing and elucidating aggregation mechanisms with a view to assisting a more rational formulation development process.

1:00 Luncheon Presentation II (Sponsorship Opportunity Available) or Lunch on Your Own

 

Understanding and Overcoming Stability Issues

2:00 Chairperson's Remarks

2:05 The Mechanism of Antibody Fragementation and its Impact on Formulation Design Space  

Sharon Gao, Ph.D., Prinicipal Scientist, Protein Sciences, aTyr Pharmaceuticals

Understanding biologics stability attributes and degradation pathways are important for development of efficacious protein therapeutics.  As majority of biopharmaceticals are produced in CHO cells, degradation by residual host cell proteases is always considered as a real possibility, particularly in early developmental stage. However, there is a surprising paucity in scientific literature pertaining to the prevalence of this phenomenon, and its impact in the context of final purified proteins. Because of its pH dependent nature, conventional formulation wisdom to address this problem is to control pH to a narrow range. This practice effectively narrows formulation design space thus limiting opportunity to better optimize drug candidate stability. In this presentation, a case study will demonstrate detection of protease activity in a highly purified monoclonal antibody, and characterization of proteolytic fragments. 

2:35 Implementation of Protease Detection Method in Process Development will Improve Product Quality and Drug Substance Stability.

Tudor Arvinte, Ph.D., Professor, Department of Biopharmaceutics, University of Geneva; CEO, Therapeomic, Inc.

This talk will present protein case studies and newly developed orthogonal methods to analyze protein aggregation in formulations in conditions as near as possible to those in which the drug is applied in vivo. Orthogonal methods are able to detect small differences against a complex background and, if necessary, provide information on the protein properties in heterogeneous formulations such as aggregated slow release formulations, or proteins adsorbed onto adjuvants in vaccines.

3:05 Phase Separation in Liquid Biologics Formulations:  Impact of Excipient Degradation

Yatin Gokarn, Ph.D., Associate Director, Late Stage Pharmaceutical Development (LSPD), Genentech

3:35 Sponsored Presentation (Sponsorship Opportunity Available)

3:50 Networking Refreshment Break

4:15 Causal Factors and Correlations in Freeze-Dried Protein Stability

Marcus Cicerone, Ph.D., Research Chemist, Polymers, NIST

Protein secondary structure and alpha relaxation of the freeze-dried solid have been used as metrics for predicting the effectiveness of a freeze-dried formulation, but these metrics are not quantitative, and not always reliable. I will present evidence that protein secondary structure in the freeze-dried solid is only a correlation, and only holds in a limited regime. Also, in order to be quantitative, alpha relaxation data must be supplemented by beta relaxation data.

4:45 Solidification of Protein Solutions Using Clathrate Hydrates as a Potential Stabilization Tool

Evgenyi Shalaev, Ph.D., Associate Research Fellow, Pharmaceutical Development, Pfizer

A common way to improve stability of proteins is to convert their aqueous solutions to the solid state by freezing or freeze-drying, with both processes including water-to-ice conversion.  As a potential alternative, solidification of protein solutions by clathrate hydrates has been considered.  The presentation covers both fundamental physical chemical requirements for protein stabilization by clathrates and experimental investigation of model protein systems.

5:15 Overcoming Stability Issues and Successfully Completing Technology Transfer

Daniel Adams, Executive Chairman, Protein Sciences, Founder, Biogen

Companies that are developing biologics inevitably face the issue of demonstrating stability and successfully executing technology transfer to a large scale manufacturing facility. The issues are essentially the same whether the transfer is to a new, in house large scale manufacturing facility or a contract manufacturer. Demonstrating stability is essential for regulatory approval and continues to be an ongoing requirement after approval. It is critical to successful technological transfer. In addition, technology transfer is much more than transferring a "recipe" and no matter how complete your SOPs are, Murphy's law prevails. It is a lot of work and takes much longer than expected.

5:45 – 7:00 Welcoming Reception in Exhibit Hall, Poster Viewing


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Links to Companion Meetings

Pipeline 1 

Protein-Device Combinations 

Lyophilization and Emerging Drying Technologies 

Protein Aggregation and Emerging Analytical Tools