2015 BPD Header

Cambridge Healthtech Institute’s 3rd Annual
Overcoming Formulation Challenges for Biopharmaceutical Development:
Formulation and Process Optimization, Analytics, Device Integration and New Biologics
August 3-4, 2015
Part of CHI's 7th Annual The Bioprocessing Summit

August 3-7, 2015 | Westin Copley Place Hotel | Boston, Massachusetts

The popular third annual Overcoming Formulation Challenges for Biopharmaceutical Development conference will cover latest trends and challenges in biologic formulations development, process optimization, manufacturing, and device and packaging considerations for existing and emerging protein therapeutics. The conference will showcase case studies, especially unpublished and innovative work, on the use of the effective scale up strategies, excipient induced instability, process challenges, fill finish challenges, and predictive tool for rapid formulation and stability screening. We invite you to attend to learn from and network with the leading experts from around the world in the field of biologics formulation development.

Day 1 | Day 2 | Short Courses | Download Brochure 

Monday, August 3

8:00 am Pre-Conference Registration and Morning Coffee

9:00-11:30 Recommended Short Course

Accelerated Stability Testing of Biologics 

11:30 Main Conference Registration


1:00 pm Chairperson’s Opening Remarks

Sandeep Yadav, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

1:10 Polysorbate 80 Hydrolysis and Rationale for Determining the Effective Level of Polysorbate 80 in a High Concentration Monoclonal Antibody Formulation

Vincent Corvari, Ph.D., Senior Research Advisor, Bioproduct Research & Development, Eli Lilly & Company

During the development of a solution formulation for a high concentration monoclonal antibody, a reduction in the content of polysorbate 80 occurred on stability. Further evaluation demonstrated the reduction resulted from hydrolysis of the fatty acid side chains. The focus of this presentation is to describe the knowledge gained while identifying this degradation pathway and the development work conducted to define the effective level of polysorbate 80 required to maintain product quality.

1:45 Is PS-80 a Critical Excipient? A Short History and Case Studies

Michael T. Jones, Ph.D, Research Fellow, Biotherapeutics Pharmaceutical Sciences, Analytical R&D, Pfizer, Inc.

Polysorbates are ubiquitous as excipients in protein formulations. These surfactants are added to the formulation to help maintain the stability of the drug product (DP). There has been an increased interest in the biopharmaceutical industry to understand the fate of these surfactants over the shelf-life of the DP. This talk will highlight some of the issues with polysorbates and provide case studies on the criticality of PS80 addition to a protein DP.

2:15 Critical Considerations for Surfactant Stability in Biopharmaceutical Formulations

Sandeep-YadavSandeep Yadav, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

Polysorbate is commonly used excipient in biotherapeutic formulations for protection against interfacial stress and surface adsorption. In this work we present evidence of Polysorbate degradation over long-term 5OC storage that may subsequently result into visible and subvisible particles in protein formulation. A number of challenges associated with characterizing particulates, identifying potential reasons for Polysorbate degradation, novel methods to quantify the degradants as well as the solubility characteristics of the PS20 degradants are discussed.

2:45 Refreshment Break

3:15 Challenges in Co-Formulating Polysorbates and Preservatives in Multi-Use Biologics Formulations

Shuai-ShiShuai Shi, Ph.D., Associate Principal Scientist, Sterile Product and Analytical Development, Merck


3:45 Development and Application of a Stability Indicating LC-MS Assay for PS-80 for Biotherapeutics

Mark Bolgar Ph.D., Senior Research Fellow, Analytical and Bioanalytical Development, Bristol-Myers Squibb Co.

4:15 Breakout Discussions

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. Then continue the discussion as you head into the lively exhibit hall for information about the latest technologies.

5:15 Discussion Report-Outs

5:30 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:00 End of Day

Day 1 | Day 2 | Short Courses | Download Brochure 

Tuesday, August 4

7:30 am Registration and Morning Coffee


7:55 Chairperson’s Remarks

Kevin Constable, Director, Technology Development, Terumo- Global Pharmaceutical Solutions.

8:00 Transformational Science: Moving from the Challenges of High Concentration mAbs to Meeting the Needs of Highly Potent Bispecifics

Sachin-DubeySachin Dubey, Ph.D., Head of Formulation Development, Process Development, Glenmark Pharmaceuticals SA

Glenmark’s proprietary BEAT® technology has provided a new impetus toward developing a more efficient way of treating cancer. This highly effective therapeutic (anticipated doses ~ 1000 fold less than conventional mAbs) has conserved key IgG properties (thermostability, effector function/antibody-like pharmacokinetics etc), but at the same time has thrown up new challenges, particularly in terms of formulation/analytical development. These low-concentration related challenges were rationally understood, characterized and mitigated.

8:30 Considerations and Approaches for Late Stage Formulation Development of Biologics

Hardeep-SamraHardeep Samra, Ph.D., Senior Scientist, Formulation Sciences, MedImmune, Inc.


9:00 QbD in Late Stage Formulation Optimization

Mark-YangMark Yang, Ph.D., Director, Fill Finish Development, Genzyme - a Sanofi Company

QbD is a powerful tool for late stage formulation optimization and process definition. However, there is a delicate balance between testing many variables over a wide range for a robust process and minimizing the “process changes” to be implemented. A QbD case study will be presented. After identified key excipients, the formulation was optimized by using a response surface design to include multilevelsof key excipients over a manufacturing-relevant range.

9:30 Sponsored Presentation (Opportunity Available)

9:45 Coffee Break in the Exhibit Hall with Poster Viewing

10:30 FEATURED PRESENTATION: Mixing Monoclonal Antibody Formulations Using Bottom-Mounted Mixers – Impact of Mechanism and Design on Drug Product Quality

Yuh-Fun Maa, Ph.D., Principal Engineer, Pharmaceutical Processing and Technology Development, Genentech, Inc. 

Although BMM is becoming a choice of mixing but impact of BBM on protein drug product is yet to be understood. This study evaluated multiple disposable BBMs to assess their impact on a shear-sensitive mAb formulation. Aggregation of mAb, and particle formation were determined after mixing. The results suggested that mixer designs with contact between the impeller and the drive unit resulted in higher particle counts. The shear-induced particles are proteinaceous but soluble aggregated protein molecules were not detected. This study fills an important gap in understanding a critical bioprocessunit operation.

11:00 Presentation to be Announced

11:30 Application of Automated and High-Throughput Systems to Formulation Development of Biopharmaceuticals

Russell Burge, Ph.D., Applications Scientist, Freeslate, Inc.

Biologics can be prone to degradation and instability, both of which pose challenges to drug developers. In this presentation, we describe the application of automation and high throughput data management systems to drug development workflows. Results of case studies demonstrating the ability of automated workflows to increase throughput, improve efficiency, and streamline data management.

12:00 om Panel Discussion: Challenges and Opportunities in QbD Approach in Formulation Development and Product Quality

Moderator: Mark-YangMark Yang, Ph.D., Director, Fill Finish Development, Genzyme – a Sanofi Company



Sachin-DubeySachin Dubey, Ph.D., Head of Formulation Development, Process Development,

Glenmark Pharmaceuticals SA


Hardeep-SamraHardeep Samra, Ph.D., Senior Scientist, Formulation Sciences, MedImmune, Inc.


Yuh-Fun-MaaYuh-Fun Maa, Ph.D., Principal Engineer, Pharmaceutical Processing and

Technology Development, Genentech, Inc.


Russell Burge, Ph.D., Applications Scientist, Freeslate, Inc.

12:30 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Session Break


1:55 Chairperson’s Remarks

Hardeep Samra, Ph.D., Senior Scientist, Formulation Sciences, MedImmune, Inc.

2:00 A Novel Analytical Approach to Investigate the Effect of Methionine Oxidation on Antibody PK

Jan Stracke, Ph.D., Principal Scientist, Pharmaceutical Development & Supplies, PTD Biologics Europe, F. Hoffmann-La Roche Ltd.

Preserving the chemical and structural integrity of antibodies during manufacturing and storage is a major challenge during development. Oxidation of Fc methionines is frequently observed, which leads to reduced affinity to FcRn and faster plasma clearance if present at high levels. A novel pH-gradient FcRn affinity chromatography method was developed to isolate antibody oxidation variants from an oxidized IgG1 preparation based on their FcRn binding properties. The subsequent physico-chemical and biological characterization of these oxidation variants demonstrated the value of the new method to study structure-function relationships.

2:30 Developability Assessment and Formulations Optimization of Biologics Using Isothermal Chemical Denaturation (ICD)

Richard K. Brown, Ph.D., President, AVIA Biosystems

Stability optimization and aggregation minimization are two of the most important hurdles in the development of biologics. ICD provides the most accurate way of measuring protein stability under different formulation conditions. ICD experiments performed at different protein conc. provide a quantitative assessment of protein aggregation in the native and denatured states. ICD is ideally suited to optimize the formulation of highly concentrated formulations, bispecific antibodies and antibody drug conjugates. In this talk, the fundamentals of ICD and its application to the evaluation of protein stability and optimization of formulation conditions will be discussed.

3:00 HDX-MS Sheds Mechanistic Insights on Mutation Induced Changes in Physical Stability of an IgG1 mAb Engineered For Extended Serum Half-Life

Ranajoy Majumdar, Ph.D., Research Scientist, Biophysical Characterization, Biopharmaceutical Research and Development, Eli Lilly and Company

A triple mutation in the CH2 domain of an IgG1 mAb intended to increase in vivo half-life resulted in decreased physical stability. Although the mutation induced minimal differences in H/D exchange kinetics at the mutation sites and the FcRn binding epitopes, it increased the flexibility of an established aggregation hotspot in the CH2 domain. This case study reinforces our understanding of the correlations between mAb physical stability and its local flexibility.

3:30 Refreshment Break in the Exhibit Hall with Poster Viewing

4:15 A Comparison of Biophysical Characterization Techniques in Predicting Drug Product Stability

Geetha-ThiagarajanGeetha Thiagarajan, Ph.D., Senior Scientist, Sterile Product and Analytical Development, Merck & Co.

To predict stability behavior, solution-mediated interactions (Colloidal, self-association propensity) and key molecular characteristics of ten formulated protein-therapeutics were compared to their stability at accelerated (25C and 40C) and long-term storage conditions (2-8C) as measured by size exclusion chromatography. Our results show that colloidal stability, self-association propensity, and conformational characteristics (exposed Trp) provide reasonable prediction of accelerated stability, with limited predictive value at 2-8C stability. Other measurements (e.g., thermal unfolding temperature) did not show any correlation.

4:45 Forced Degradation Studies: An Essential Tool for the Formulation Development of Vaccines

Manvi Hasija, MS, Formulation and Stability Scientist, BioProcess Research and Development, Sanofi Pasteur

The guidelines for forced degradation (FD) regarding biologics have few to none procedural instructions on how to approach studies. There are gaps that are left to interpretation by the vaccine developer. In this presentation, we provide an overview of the methods to study FD in vaccines as well as mechanisms of degradation, analytical methodology, FD examples that are used to influence the results of new vaccine candidates.

5:15 Close of Conference

6:00-8:30 Recommended Dinner Short Course

Protein Aggregation: Mechanism, Characterization and Consequences 

Day 1 | Day 2 | Short Courses | Download Brochure