2013 Archived Content

August 22-23, 2013

Cambridge Healthtech Institute’s Inaugural
Early IND Strategies: Process and Production

Preclinical Process Development to Support Regulatory Filings, Toxicology and Clinical Supply

Day 1 | Day 2 | Short Courses | Download Brochure 

Friday, August 23, 2013

8:00 am Continental Breakfast in the Exhibit Hall

High-Throughput and Automated Technologies to Reduce Timelines for Material Production 

8:55 Chairperson’s Opening Remarks

Shara Dellatore, Ph.D., Lead, Preclinical and Clinical Characterization, Merck & Co.

9:00 Monoclonal Antibody on Demand (MOD) Platform: Increasing Access to the Clinic with a Low Cost, Low Volume Manufacturing Process


Tanya Shang, Ph.D., Senior Principal Scientist, Analytical R&D, Pfizer


A new mAb development and manufacturing paradigm is proposed that eliminates process development and right-sizes the scale of manufacturing to match initial FIH studies needs. Extensive platform knowledge and historical data were used to design the process so that it would be applicable to a broad subset of mAbs. The impact of the process on late stage development and product lifecycle will also be considered.

9:30 Optimizing Throughput in Pilot Scale Single-Use Systems

Robert J. Steininger IIRobert J. Steininger II, MS, Senior Vice President, Manufacturing, Acceleron Pharma

Making complicated proteins in sufficient quantity to enable early preclinical and clinical studies is a potential stumbling block for small start-up companies. Acceleron has chosen use single use technology (SUT) to quickly explore a family of proteins that have potential in a number of clinical applications. In choosing this path, the company has created a SUT based platform process that serves both the needs of research and development for protein supply.

Technologies and Issues Impacting Preclinical Process Development 

10:00 Preclinical Process Development in Biologics - Challenges and Concerns

Amardeep BhallaAmardeep Bhalla, Ph.D., Principal Scientist, Vaccine Research, Early Development, Pfizer



10:30 Coffee Break in the Exhibit Hall with Poster Viewing 

11:00 Using Early Results to Identify and Set CQAs 

Shara DellatoreShara Dellatore, Ph.D., Lead, Preclinical and Clinical Characterization, Merck & Co.

Merck’s quality by design (QbD) approach utilizes early identification of potential critical quality attributes (pCQAs) to drive process and analytical development.  Early identification of pCQAs enables targeted process definition prior to pre-clinical safety assessment and Phase 1 clinical supply manufacturing. This approach minimizes risk of identifying additional quality attributes during later-phase process development or scale-up.   Early pCQAs are informed by hypothesized mechanism of action, sequence and modeling predictions of “hot spots”, and targeted forced degradation and short-term stability characterization data.  Understanding these unique properties of the protein is useful for efficient process development.  A case study will be presented highlighting a three month process development effort for pre-clinical safety assessment supply for an IgG1 monoclonal antibody.  To meet target ranges for two pCQAs (charge impurity and glycan profile), the originally developed process was fine tuned.  Strategic use of pCQAs to inform early development decisions is a proven strategy to identify and meet product requirements in the preclinical space to save time, resources and money in the later, often more costly, clinical space. 

11:30 Quality by Design Considerations in Purification Process Development 

Yiming YangYiming Yang, Senior Scientist, Purification Process Development, Shire HGT

Quality by Design (QbD) is a concept of building quality into the process and product in a systematic, science, and risk based manner.  QbD principles were used in developing a late phase purification process to produce a therapeutic protein.  Practical considerations for the QbD implementation were discussed. A case study is presented to better explain the QbD considerations and  implementation.  The case study described a design of experiment (DoE) study  to define design space for the purification process. Also, a process control strategy was developed to better control the process performance and product quality. 

12:00 pm BioProduction and Formulation Patents - Opportunities and Challenges for Biotherapeutic Development

Paul CalvoPaul Calvo, Ph.D., Director, Biotechnology/Chemical Group, Sterne, Kessler, Goldstein & Fox

Bioprocessing intellectual property provides a valuable opportunity to enhance patent life that cover a biotherapeutic. Recent activity and changes in the patent system greatly impact the ability to commercialize compositions used in manufacturing biologics, as well as the manufacturing processes themselves. The changes and their implication for bioproduction commercialization strategies will be discussed.

MaxCyte12:30 Scaling from the Bench to Biomanufacturing:  Large Scale CHO Transient Transfection Using Flow Electroporation

Brady_JamesJames Brady, Ph.D., Director, Technical Applications, MaxCyte, Inc.

Flow electroporation (FEP) streamlines antibody development by enabling large scale transient gene expression (TGE) directly in CHO cells, eliminating the need to change cell backgrounds during scale up to biomanufacturing. FEP is fully scalable and produces antibody titers >1g/L with optimization and can also be used to rapidly generate high yield stable cell lines.

12:45 Sponsored Presentation (Opportunity Available)

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

1:55 Chairperson’s Remarks

Erinc Sahin, Research Investigator II, Bristol-Myers Squibb

Scale-Up and Technology Transfers in Preclinical Development 

2:00 Developing a Robust Technology Transfer 

Erinc Sahin, Research Investigator II, Bristol-Myers Squibb

Technology transfer, by definition, is an activity where key information and know-how is exchanged between two groups with the goals of high repeatability of processes as well as high quality and comparability of end products. It is also an activity that clearly shows the importance of clear expectations, targeted data collection, and organized communication. This presentation will be discussing some approaches that can be employed during biopharmaceutical formulation and drug product development to facilitate an efficient technology transfer between functional groups from multiple disciplines.

2:30 Scale-Down Modeling in Early Process Development

Shuang ChenShuang Chen, Ph.D., Senior Scientist, Pfizer

In this case study (an E.coli expressed protein), the downstream recovery and purification processes include cell harvest, cell lysis, inclusion body (IBs) recovery and wash, solubilization and refolding, and chromatography based purification.  We have demonstrated through repeated production scale runs at the 2000 L oxidation scale that process performance can be well predicted from the lab-scale results.  The scale-down modeling approach taken in early process development successfully predicts the scale-up of the downstream unit operations. 

3:00 Process Monitoring and Control in Pilot Scale Biologics Production

Seongkyu YoonSeongkyu Yoon, Ph.D., Assistant Professor, Chemical Engineering, MA BioManufacturing Center, University of Massachusetts, Lowell

Biologics manufacturers are facing challenges during scale-up due to lot-to-lot variations of critical raw material, lack of appropriate measurements of intermediate process parameters, and even inappropriate analytical test methods of final product quality attributes. The presentation will illustrate how to characterize production data in different scales and conduct comparability study. Characterization and comparability are done under multivariate statistical framework. Correlation models built with bench scale data are used for addressing different scale data. The same framework can be used for continuous process validation as well as for product/process transfer.

3:30 Rapid Production of Biologics in Emergency-Use Response: A Progress Report

Dale Cumming, Ph.D., Chief Science Officer, International Consortium on Anti-Virals, Canada

Anti-viral antibodies are ideal agents in responding to sudden outbreaks of infectious disease if available to patients within months of an outbreak. Accomplishing this goal requires employing cutting-edge GMP bioprocessing technologies and evolving an emergency-use framework with regulatory authorities. We have now completed several “live fire” exercises demonstrating progress in producing multi-gram quantities of anti-influenza antibodies within months and have commenced discussions with regulators.

4:00 End of The Bioprocessing Summit

Day 1 | Day 2 | Short Courses | Download Brochure 


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