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2014 Archived Content

Cambridge Healthtech Institute’s Sixth Annual
Optimizing Biologics Formulation Development
New Product Formats, Emerging Analytical Methods and Solving Problem Formulations
January 13-14, 2014


The Sixth Annual Optimizing Biologics Formulation Development meeting will focus on how the formulation function is responding to the challenges of new product formats, increased regulatory scrutiny and early developability screening of product candidates based on stability and other formulation characteristics. Join your colleagues from around the world in this popular annual discussion of the key challenges and solutions in biologics formulation development, with an emphasis on case studies and lessons learned.

Day 1 | Day 2 | Download Development Brochure | Speaker Biographies 

 

SUNDAY, JANUARY 12

 

4:00-5:00 pm Short Course Registration

5:00-8:00 Dinner Short Courses (SC1-SC7) More Details >> 

4:00-8:00 Main Conference Registration

 

MONDAY, JANUARY 13

7:30 am Conference Registration and Morning Coffee

 

Predictive Analytical Studies 

9:00 Chairperson’s Opening Remarks

Steven LaBrenz, Ph.D., Scientific Director, Drug Product Development, Janssen R&D

 

Keynote Presentation

9:10 Major Trends and Challenges in Biotherapeutic Product Development

Hanns-Christian MahlerHanns-Christian Mahler, Ph.D., Head Pharmaceutical Development & Supplies, Biologics EU, F. Hoffmann-La Roche

The formulation and characterization of therapeutic proteins is of utmost importance to enable new therapeutic options in diseases with inadequate treatment options. Yet, these molecules pose specific challenges during development and commercialization. This talk aims to provide considerations and examples for major trends and typical challenges encountered in pharmaceutical and product development of protein products.

9:50 High-Throughput Biophysical Analysis of IgG1 mAb Stability and Preliminary Correlations with Local Flexibility as Measured by H/D Exchange Mass Spectrometry

David VolkinDavid Volkin, Ph.D., Takeru and Aya Higuchi Distinguished Professor, The University of Kansas

This presentation will examine high-throughput biophysical techniques and data visualization tools to assess the physical stability of IgG1 mAbs. Illustrative case studies with (1) mAbs of varying glycosylation, and (2) different mAb solutions exposed to various accelerated stress conditions will be presented. In addition, the conformational stability and aggregate propensity of an IgG1 mAb in the presence of different salts will be presented in the context of preliminary correlations to local protein flexibility measurements using H/D-exchange mass spectrometry.

10:20 Coffee Break

10:45 Correlation of Predictive Analytical Studies with Actual Results

Vladimir RazinkovVladimir Razinkov, Ph.D., Principal Scientist, Amgen

This presentation is focused on the development and application of high throughput methods that can lead to a faster and better evaluation and prediction of formulation properties and the improvement of biopharmaceutical development. We describe several analytical and accelerated stress techniques combined into one methodology in order to obtain a comprehensive characterization profile and ultimately to predict quality parameters of protein formulations. Case studies for monoclonal antibody formulations will be presented.

11:15 Predictive Analytical Studies to Support the Development of High Concentration Protein Therapeutics

Mark BraderMark Brader, Ph.D., Principal Scientist, Biogen Idec

 

 

11:45 Formation and Characterization of Glycation on Recombinant Monoclonal Antibodies (MAbs)

Hong Liu, Ph.D., Senior Research Associate, Early Stage Pharmaceutical Development, Genentech

Protein glycation can cause structural heterogeneity among the population of MAbs. Characterization and control of glycation modification have become increasingly important to ensure product quality as well as manufacturing process consistency for recombinant MAbs in the biopharmaceutical industry. This oral presentation will review the general impact on MAb glycation in a typical CMC process. A case study will be presented to discuss the formation, change and control of glycation of a specific MAb.

12:15 pm Panel Discussion with Session Speakers

Freeslate12:45 Luncheon Presentation: Highly-Automated Procedures for the Assessment of Protein Formulations

Burge_RussellRussell G. Burge, Ph.D., Application Scientist, Freeslate, Inc.

A highly automated process was devised to prepare and analyze samples for the formulation development of proteins. Automation increased efficiency of the activities compared to current methods and procedures. Forty eight protein formulations were generated together with placebos. Automated procedures were employed for appearance (color, turbidity, and particles), viscosity, and pH testing. Spectrophotometry, chromatography and light scattering were performed using semi automated procedures. Performance of the formulations was evaluated after subjecting the vials to stress conditions.
  

Automation and Data Management 

2:00 Chairperson’s Remarks

Murali BilikallahalliMurali Bilikallahalli, Ph.D., Associate Director, Formulation Sciences, Proteins, Vaccines & Oligos, MedImmune

 

 

 

2:05 Use of Automation and High-Throughput Analysis in Formulation Development

Steven LaBrenzSteven LaBrenz, Ph.D., Scientific Director, Drug Product Development, Janssen R&D

Protein formulations cover a large number of possible parameters: concentration, pH, osmolarity, etc. In an effort to achieve consistent and expedient development of phase 1 clinical formulations, the protein formulation group at Janssen R&D created a standardized, automated workflow, screening multiple IgG molecules for a single program in 5-6 weeks. Standardized data analysis was a more difficult process to complete and remains an ongoing task to visualize workflow outputs.

2:35 Evaluation of Protein Silicone Oil Compatibility in Pre-Filled Glass Syringes

Shujun BaiShujun Bai, Ph.D., Scientist, Protein Pharmaceutical Sciences, Biogen Idec

Interaction of silicone oil (SO) with a protein can exert influences on product quality. Our compatibility study was conducted on protein formulation filled into BD prefilled syringes with different siliconization levels, including 0, 0.4, 0.8 and 1.2 mg SO per syringe; elevated subvisisble particle counts were obtained at higher siliconization levels, however there was no noticeable correlation between siliconization levels and protein degradation, it is concluded that the protein formulation is compatible to the silicone oil levels in the syringes.

3:05 Automation and Data Management in Early Vaccine Formulation Development

Nicolas MoniotteNicolas Moniotte, Ph.D., Technology Development Leader, R&D Formulation Development, GlaxoSmithKline Vaccines

Unlike small chemical compounds, many biological preparations, such as vaccines, are highly unstable and their stability depends on many physic-chemical factors, making the formulation development empirical. During the last decades, introduction of automation and IT tools has deeply modified the ways of working in the biopharmaceutical industry. Our aim is to show how automation can be used to support formulation development, mainly during the early steps of vaccine formulation process development.

3:35 Selected Oral Poster Presentation: Development of a Lyophilized Nanoemulsion Adjuvanted Vaccine against Tuberculosis

Ryan Kramer, Ph.D., Manager, Characterization and Production Development, Infectious Disease Research Institute

3:50 Refreshment Break

 

Measuring and Controlling in-Use Stability 

4:15 Designing In-Use Stability Studies with Customer Focus

JasonCheungJason K. Cheung, Ph.D., Principal Scientist, Sterile Product Development, Merck

Protein therapeutics are formulated to optimize quality and stability throughout product shelf-life. However, in many cases the drug product is administered intravenously and requires dilution with a separate vehicle (e.g., normal saline or 5% dextrose solution).  In these situations, it is important to confirm consistent ‘in-use’ product quality through appropriate developmental characterization studies.  Often, analytical limitations need to be overcome in order to characterize protein therapeutics at very low in-use concentrations.  This talk will focus on study designs and approaches to minimize potential challenges to in-use protein characterization.

4:45 In-Use Stability Challenges for Protein Therapeutics

Meera AgarkhedMeera Agarkhed, Principal Associate, Formulation Development, ImClone Systems, a Wholly-Owned Subsidiary of Eli Lilly & Co.

This presentation will discuss regulatory guidelines and potential issues and challenges that protein therapeutics experience during dose preparation, hold and administration. A case study will be presented to discuss in-use physical, chemical and microbial stability of a monoclonal antibody.

 

5:15 Challenges in Formulation of High Concentration Monoclonal Antibody Formulations: Effect and Mitigation of iso-Asp Formation

Henrik Rajesh Kumar ParshadHenrik Rajesh Kumar Parshad, Ph.D, Principal Scientist, Biopharm Formulation Development, Novo Nordisk A/S

Aggregation formation has received much interest mainly due to potential safety concerns, but loss of efficacy by iso-Asp formation is not as widely discussed. The presentation will focus on the necessity to address iso-Asp formation in the early stages of development, and formulation strategies to control this. Data is presented showing the effect of formulation pH and storage temperature on iso-Asp formation and how this affects the bioactivity of the mAb.

Protein Simple

5:45-7:00 Welcome Reception in the Exhibit Hall with Poster Viewing 

 

Day 1 | Day 2 | Download Development Brochure | Speaker Biographies