PAT for Downstream Bioprocess Optimization
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Recent Talks on Downstream Bioprocessing

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This August 19 digital event comprises of three recent presentations, which share best practices and trends around the optimization and control of downstream bioprocessing.

Recent Talks on Downstream Bioprocessing
Recent Talks on Downstream Bioprocessing
Featuring presentations from Sanofi, Bristol-Myers Squibb, and GlaxoSmithKline, this free online event on August 19, 2020 is for scientists and engineers who are interested improving process performance by identifying, understanding and optimizing critical process parameters involved with downstream processing (DSP) of Drug Substances (DS), vaccines, excipients and/or bio conjugates. 

Presentations include:
  • Real-Time Monitoring of Downstream Biologics Operations
    Greg Lane - Bristol-Myers Squibb

  • Low pH Virus Inactivation for Monoclonal Antibodies
    Hiren D. Ardeshna - GlaxoSmithKline

  • Aluminum Phosphate Vaccine Adjuvant: Composition and Size Analysis Using Offline and Inline Tools
    Marina Kirkitadze - Sanofi

During this live stream, a technology and application expert will be online to answer your questions live.

Tyler Gable - METTLER TOLEDO
2 Hours
Wed Aug 19 2020 13:00 +0000 [ English ]


Key Topics

  • Identifying factors that could contribute to bottlenecks and impurity formation during bioprocess development
  • Understanding how process conditions impact protein concentration and product yield
  • Overcoming the challenges associated with offline analytical techniques, including inaccuracy and time delays
  • Monitoring unit operations such as purification, chromatography, buffer exchange, up-concentration and formulation 

Cost

There is no cost to attend but registration is required and space is limited.

Your Presenters

Greg Lane - Bristol-Myers Squibb
Greg started at Bristol-Myers Squibb Company as a PhD Organic Chemist in the Small-Molecule API Process Technology Department. During that time, he developed scalable syntheses and utilized Process Analytical Technology (PAT) to monitor reactions and crystallizations from the lab to the pilot plant. In 2016, he moved to the Drug Product Science and Technology department, with a focus on oral solid dosage forms and biologics production. His efforts involve using Raman and other PAT to monitor and control upstream bioreactor production. This led to requests to be able to monitor downstream unit operations. As Greg likes to say: “Proteins are molecules, too!”

Hiren D. Ardeshna – GlaxoSmithKline
With years of experience in downstream process development, CMC, and process scale up, Hiren Ardeshna is a Scientific Leader at GlaxoSmithKline. Hiren leads a team of development scientists responsible for scale-up and technology transfer for various GSK assets to clinical and commercial manufacturing sites, including the required process development and characterizations support. Hiren earned a Masters in Chemical Engineering from the University of Massachusetts with focus on biotechnology process development and Harvest/clarification, normal flow filtration, and process economic evaluations.

Marina Kirkitadze, Ph.D. - Sanofi Pasteur
Marina Kirkitadze, Ph.D, MBA has 17 years experience with Sanofi Pasteur, the vaccine division of Sanofi group. She is the Head of Analytical Process Support and PAT Platform, Analytical Sciences Toronto. Marina's main focus is characterization of vaccine components, specifically, protein conformation and stability in solution and in adjuvanted form, analysis of raw materials, particle sizing technologies, and inline PAT applications. Her contributions went towards CMC section in eBLA application for Adacel, new manufacturing facility submission, Pentacel, and to Module 3 CTD of Hexaxim vaccine submission. Marina has published 36 manuscripts.

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