Cambridge Healthtech Institute’s Third Annual
Higher-Order Protein Structure
Characterization, Prediction, Comparability and Biosimilars
Part of CHI’s 6th Annual The Bioprocessing Summit

August 21-22, 2014 | Renaissance Waterfront Hotel | Boston, Massachusetts

Understanding of the biomolecular structure of proteins is of high importance in drug development process. Biophysical properties such as protein dynamics, conformation, self-association, aggregation and particulate formation affect the quality attributes of protein therapeutics.  Detailed knowledge and characterization of the underlying proteins and their behavior thus enables assessment of how protein structure is affected by manufacturing, storage, handling and delivery; and, in turn, allows researchers to better determine the impact on safety and efficacy.

This popular annual conference will feature informative, high-quality case studies and successful strategies to overcome the problems you are facing in the rapidly changing higher-order protein structure landscape. We invite you to attend to learn from and network with the leading experts from around the world.

Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios 

Suggested Short Course*

Biophysical Characterization in Developing Biopharmaceuticals: The Path to Developability, Stability and Comparability 

Thursday, August 21, 6:30-9:30 pm

*Separate registration required

Thursday, August 21


1:55 pm Chairperson’s Remarks

Yatin R. Gokarn, Ph.D., Narotam Sekhsaria Distinguished Professor of Chemical Engineering, Institute of Chemical Technology, Mumbai, India


Characterization of Protein Higher Order Structure in Comparability & Biosimilarity: A Regulatory Perspective

Maria-Teresa Gutierrez-Lugo, Ph.D., Product Quality Reviewer, Division of Therapeutic Proteins, OBP/Center for Drug Evaluation and Research, US Food and Drug Administration

Protein Higher Order Structure (HOS) plays a critical role in a product’s activity and  stability. Differences in protein HOS between a reference product and a proposed biosimilar product have the potential to impact product performance. This presentation will provide an overview of the regulatory expectations for analytical similarity with a focus  on the evaluation of HOS. Challenges related to an assessment of HOS using current methodologies will be also discussed.

2:45 Measuring Higher-Order Structure of Proteins: Rationale, Methodologies and Expected Outcomes

RatinGokranYatin R. Gokarn, Ph.D., Narotam Sekhsaria Distinguished Professor of Chemical Engineering, Institute of Chemical Technology, Mumbai, India

Subtle changes in the complex 3-D structures of protein-based drugs can have profound effects on efficacy and safety. Therefore the HOS of protein-drugs needs to be carefully analyzed and tracked through various stages of development, and product cycle. We present an approach that combines analyses of global solution state and behavior along with signatures of secondary and tertiary structure using orthogonal biophysical techniques. We show that a consistent, information-rich HOS map can be created for a given molecule, which can be helpful towards establishing analytical comparability.

3:15 Understanding the Importance of Local Structure for Protein Stability

JenniferLaurenceJennifer S. Laurence, Ph.D., Associate Professor, Department of Pharmaceutical Chemistry, University of Kansas

Stability depends on both protein composition and the solution environment into which it is placed. Standard approaches to examining protein stability rely on global measures of structure or aggregation of the product. These low-resolution techniques facilitate rapid identification of compatible conditions, but insight about how stabilization is achieved has remained elusive. Solution NMR was used to detect changes to individual residues, and specific influences on stability were extracted from cross-correlation with standard evaluation methods to assess mechanisms of instability in proteins.

3:45 Sponsored Presentation (Opportunity Available)

4:00 Refreshment Break in the Exhibit Hall with Poster Viewing


4:45 Assessing Aggregate Content in Originator Products as a Specification Guideline for Biosimilars

ChristinaVesselyChristina R. Vessely, Director, CMC & Regulatory Affairs, KBI Biopharma

Setting specifications for aggregate content in early clinical stages for a biotechnology product can be challenging due to limitations of analytical methods and limited experience in the clinic. In the case of biosimilars, the specification must also consider aggregate levels in the originator product. This presents an additional challenge because biosimilar companies typically don’t have access to true T=0 originator material. This presentation discusses strategy for setting an appropriate aggregate specification for a biosimilar product.

5:15 A Unique High-Throughput Assay for Determination of the Comparability of the Potency and Neutralizing Antibody Response to Biosimilars and Innovator Products

MIchaelToveyMichael G. Tovey, Ph.D., INSERM Director, Research, Laboratory of Biotechnology and Applied Pharmacology, ENS-Cachan, France

Successful development of biosimilars is dependent upon the establishment of validated and standardized assays that allow direct comparisons of the relative potency and immunogenicity of innovator molecules and biosimilars. A validated standardized high-throughput cell-based assay platform will be described that is applicable to most biopharmaceuticals and that allows the direct comparison of drug potency and anti-drug neutralizing antibody responseof innovator molecules and biosimilarsin the same assay.

5:45 End of Day

5:45 – 6:30 Dinner Short Course Registration

6:30 – 9:00 Dinner Short Course*: Biophysical Characterization in Developing Biopharmaceuticals: The Path to Developability, Stability and Comparability 

*Separate registration required

Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios