New Paradigm of Building Quality during Manufacture – Challenges with Biological Products

23rd August 2017 | 10 AM EST | Dr Rajesh K. Gupta, Biologics Quality & Regulatory Consultants, LLC |WATCH FOR FREE

Historically, quality of biological products has been ensured through testing representative samples. The shift in quality paradigm started with the implementation of Good Manufacturing Practice (GMP) regulations with the current focus on building quality during manufacture. Inherent variability and complexity of biological products pose challenges in implementing Quality by design (QbD) concept. This presentation discusses ways to build quality during manufacture of biological products.

Presented by Dr Rajesh K. Gupta
Rajesh K. Gupta has a Ph.D. in microbiology and is Principal Consultant at the Biologics Quality & Regulatory Consultants, LLC. He has more than 35 years’ experience in the development, production, testing and regulation of biologics, working at both the regulatory agencies and the industry. At FDA, CBER, he was a Deputy Director and Lab Chief in the Division of Biological Standards and Quality Control, managing lot release of biological products, regulatory reviews of analytical methods in the biologics license applications (BLA), generation of reference standards and development of new methods. In his previous jobs, he worked at the Biologics Consulting Group, Wyeth, Chiron, Massachusetts Public Health Labs and National Institutes of Health (NIH), in the USA and at National Institute of Immunology and Central Research Institute in India. His major accomplishments are in adjuvants and delivery systems for vaccines, polysaccharide-protein conjugate vaccines, combination vaccines and development and validation of analytical methods. In these areas, he has published more than 100 papers in peer reviewed journals and books and made numerous presentations at scientific and regulatory meetings.


Sponsored by Merck


Considerations for Manufacturing Commercial Antibody Drug Conjugates (ADCs) – A CMO Perspective

ADC manufacturing presents a unique set of challenges as compared to the well established practices employed for more traditional biologic products.  A team from MilliporeSigma will discuss the considerations that must be addressed to successfully manufacture ADCs.  Topics will include Facility Design, Process Control Strategy, Advantages of Single Use Systems, Cleaning Validation, Regulatory Strategy and much more.

Presented by Dr Jyothi N. Swamy and Josh Morris, MilliporeSigma

Jyothi has been in the pharmaceutical industry for over 25 years covering areas ranging from analytical method development, method validation, cleaning validation, stability, project management and marketing.

Jyothi has been with MilliporeSigma, a business of Merck KGaA, Darmstadt Germany, for over 11 years in various roles, including Sr. Chemist, Quality Control Supervisor, Sr. Project Manager. Jyothi is currently the Head of Global Marketing focusing on ADCs. Jyothi was an integral part of MilliporeSigma and Baxter collaboration working out the integration process with Baxter’s counterparts.

She received her B.S. and M.S. at Bangalore University, India, M.S. at Indian Institute of Science, India, her Ph.D. in Synthetic Organic Chemistry at University of Missouri, St. Louis.


Josh has been in the pharmaceutical and biotechnology industry for over 7 years in positions including project management, GMP biologic contract manufacturing, process/analytical development, and quality control.

Josh has been with MilliporeSigma, a business of Merck KGaA, Darmstadt Germany, for 4 years in roles including senior manufacturing scientist and currently as a custom manufacturing project manager. As both an individual contributor and a project manager, Josh has lead commercial biologics readiness operations supporting the MilliporeSigma ADC commercial manufacturing facility. Josh has received a B.S. in chemistry from Old Dominion University, and a M.S. in chemistry from Southern Illinois University Edwardsville.


To answer any regulatory questions, Mark Cooley, MilliporeSigma will also be joining this webinar

Mark has 21 years of experience in the pharmaceutical industry and has held a variety of management roles in QC and QA.

Mark has been with MilliporeSigma, a business of Merck KGaA, Darmstadt Germany, for 7 years and is currently the Head of Site Quality for the St. Louis Cherokee site which manufactures APIs, excipients and biological buffers for the pharma industry, including antibody drug conjugates (ADCs).

He received bachelor degrees in Chemistry and Biology from the University of Northern Iowa.



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