Cambridge Healthtech Institute’s 8th Annual

Optimizing Biologics Formulation and Stability

New Technologies, Case Studies, and Research Updates on Development of Novel Biologics

August 26 - 27, 2020 ALL TIMES EDT

The eighth annual Optimizing Biologics Formulation and Stability conference will cover latest trends and challenges in formulations development of novel biologic formats, process optimization, manufacturing, and device and packaging considerations for existing and emerging protein therapeutics. This year’s conference will also discuss the role of machine learning and automation in formulation screening and development. We are seeking case studies, especially unpublished and innovative work on co-formulation, formulation of novel biologics, development and delivery of high-concentration protein formulations, effective scale-up strategies, excipient-induced instability, process challenges, fill-finish challenges, and predictive tools for rapid formulation and stability screening.

Wednesday, August 26

10:25 am Coffee Break - View Our Virtual Exhibit Hall

HIGH-CONCENTRATION PROTEIN FORMULATIONS

10:45 am Post-Approval Implementation of Frozen Drug Substance Process – Challenges and Opportunities
Rong Gloria Li, PhD, Associate Director, Global MSAT, Global MSAT, Sanofi

In this presentation, LCM exercise for post-approval change of liquid drug substance into frozen platform will be discussed. Development efforts, engineering solutions, and filing strategy will be described.

11:05 am A Mechanistic Model to Account for the Donnan and Volume Exclusion Effects in UF/DF Process of Protein Formulations
Zhao Yu, PhD, Associate Senior Consultant Engineer, Bioproduct Research and Development, Eli Lilly and Company

Donnan and volume exclusion effects during ultrafiltration and diafiltration of highly concentrated proteins can cause a large shift of pH and composition from the target formulation. In order to predict and compensate for those effects, a mechanistic model is developed and example applications of the model will be given. The model can be used to understand the extent of Donnan and volume exclusion effect as a function of the protein characteristics and formulation conditions, and as a tool to design the process and control strategy to achieve target formulation in UF/DF operation. 

11:25 am LIVE Q&A:

Session Wrap Up

Panel Moderator:
Sanket Patke, PhD, Senior Scientist, Biologics Drug Product Development, Sanofi
Panelists:
Rong Gloria Li, PhD, Associate Director, Global MSAT, Global MSAT, Sanofi
Zhao Yu, PhD, Associate Senior Consultant Engineer, Bioproduct Research and Development, Eli Lilly and Company
12:05 pm Lunch Break - View Our Virtual Exhibit Hall

TARGETED FORMULATION AND DELIVERY TECHNOLOGIES

12:35 pm Microfluidics: An Advanced Platform for Pharmaceutical Protein Formulations and Antibody Tests Development
Sabirudiin Mirza, PhD, Senior Research Fellow, School of Engineering and Applied Science, Harvard University

Protein-based therapies hold an enormous potential for treating many terminal diseases. Nevertheless, the lack of universal technological approaches that enable development of protein formulations with the targeted attributes significantly impedes clinical translation of these advanced therapies. This presentation will overview the use of droplet-based microfluidic technology for developing protein formulations with pre-programmed functional characteristics, including size and internal morphology, encapsulation efficiency, and protein release profile. In addition, an overview of microfluidic devices offering accurate and cost-effective measuring antibodies in blood samples will be provided. 

12:55 pm PANEL DISCUSSION:

Session Wrap Up

Panel Moderator:
Sanket Patke, PhD, Senior Scientist, Biologics Drug Product Development, Sanofi
Panelist:
Sabirudiin Mirza, PhD, Senior Research Fellow, School of Engineering and Applied Science, Harvard University
1:35 pm Refresh Break - View Our Virtual Exhibit Hall

PLENARY KEYNOTE SESSION: LEADING TO TOMORROW'S ADVANCES

1:50 pm Chairperson's Remarks
Dominic Clarke, PhD, ISCT Process & Product Committee Co-Chair and Global Head, Cell Therapy, HemaCare Corp.
1:55 pm Scaling Cell and Gene Therapy: Challenges and Opportunities in Process Development and Manufacturing
Susan Fugett Abu-Absi, PhD, Senior Vice President, Pharmaceutical Development & Technology, bluebird bio, Inc.

The supply chain and manufacturing processes for autologous ex vivo gene therapies and engineered T-cell (e.g. CAR-T) products are complex. The rapid growth of the cell and gene therapy (CGT) field, coupled with the complexity of the products, has created an increasing challenge for manufacturers to scale to meet the needs of patients. This presentation will provide an overview of the process and analytical development and manufacturing challenges for CGT and opportunities for advancement.

2:20 pm The Future of Gene Therapy Technical Development
James Warren, PhD, Vice President, Pharmaceutical Development; Leader, Biotechnology and Gene Therapy Development, Ultragenyx Pharmaceutical

In the past few years, several cell and gene therapy products have gained regulatory approval in the US and EU with many more in the pipeline. Manufacturers of gene therapy products must tackle technological challenges under the pressure of short timelines resulting from streamlined clinical development. This presentation will focus on the key technical development challenges facing the industry as product development programs move into the later stages of process development and scale-up, process performance qualification, and ultimately, commercialization.

2:45 pm LIVE Q&A:

Session Wrap-Up

Panel Moderator:
Dominic Clarke, PhD, ISCT Process & Product Committee Co-Chair and Global Head, Cell Therapy, HemaCare Corp.
Panelists:
Susan Fugett Abu-Absi, PhD, Senior Vice President, Pharmaceutical Development & Technology, bluebird bio, Inc.
James Warren, PhD, Vice President, Pharmaceutical Development; Leader, Biotechnology and Gene Therapy Development, Ultragenyx Pharmaceutical
3:05 pm Happy Hour - View Our Virtual Exhibit Hall
3:30 pm Close of Day

Thursday, August 27

ARTIFICIAL INTELLIGENCE, MACHINE LEARNING & AUTOMATION IN FORMULATION DEVELOPMENT

9:05 am

Leveraging Automation to Enable High-Concentration Formulation Development

Peter Soler, PhD, Senior Research Investigator, Bristol-Myers Squibb Co.

Biologics drug development has experienced rapid growth in recent years. To meet the need, biologics formulation development has quickly acquired a set of automation tools and analytical techniques to provide robust drug products for patients. The push for more effective therapeutics and better patient care options has demanded higher concentrations. This has motivated adaptation of our tools to meet the increases in process complexity for the benefit of patients globally.

9:25 am Strategies to Design and Create a High-Throughput Automation Lab for Large-Molecule Biologics Formulation Development
Alexander S. Chin, Senior Scientist, Preformulation, Merck & Co.

Conversion of tedious, manual assays into automated highthroughput workflows typically consists of large capital expenditures on hardware that also require a significant investment in training of personnel and equipment. By strategically leveraging and refitting existing instruments, we efficiently converted commodity assays that focused on sample preparation and analysis into a robust, high throughput approach. Advancements in digital sample management and data capture were required to keep pace with increased sample throughput.

9:45 am Sponsored Presentation (Opportunity Available)
10:05 am LIVE Q&A:

Session Wrap Up

Panel Moderator:
Prasad Oruganti, PhD, Scientific Leader, Biopharm Product Sciences & Biopharm R&D, GlaxoSmithKline
Panelists:
Peter Soler, PhD, Senior Research Investigator, Bristol-Myers Squibb Co.
Alexander S. Chin, Senior Scientist, Preformulation, Merck & Co.
10:25 am Coffee Break - View Our Virtual Exhibit Hall

ARTIFICIAL INTELLIGENCE, MACHINE LEARNING & AUTOMATION IN FORMULATION DEVELOPMENT (CONT.)

10:45 am Automated Forced Degradation of Therapeutic Proteins
Nathan Heacock, Scientist, Biopharm Product Sciences, GlaxoSmithKline

Forced degradation of proteins are carried out to understand degradation pathways, the effect of exposure to conditions other than those proposed for storage and manufacturing, demonstrate specificity of stability indicating assays, and understand critical quality attributes. This presentation describes the development of an automated forced degradation workflow of therapeutic proteins. This workflow has significantly reduced scientist in-lab time, increased efficiency of our process, and reduced time to complete each study.

11:05 am

Integration of High Throughput Studies into Commercial Formulation Development (CFD) of Biological Therapeutics

Wei Qi, PhD, Senior Scientist, Drug Product Technologies, Amgen Inc.
11:25 am LIVE Q&A:

Session Wrap Up

Panel Moderator:
Prasad Oruganti, PhD, Scientific Leader, Biopharm Product Sciences & Biopharm R&D, GlaxoSmithKline
Panelists:
Nathan Heacock, Scientist, Biopharm Product Sciences, GlaxoSmithKline
Wei Qi, PhD, Senior Scientist, Drug Product Technologies, Amgen Inc.
12:05 pm Lunch Break - View Our Virtual Exhibit Hall
12:05 pm Close of Optimizing Biologics Formulation and Stability Conference