Specifications don’t tell the whole story: how to choose GMP process and QC equipment

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

Specifications don’t tell the whole story: how to choose GMP process and QC equipment

Cell and gene therapy equipment choice can impact the quality of the final drug product. In this session, concrete examples and data will drive a discussion about equipment choice for CGT. We will provide examples of the data you should be asking for from manufacturers before purchasing QC, QA, and process equipment. For instance, design and engineering behind the scenes, as well as features that become more important as your institution grows, will impact your production timelines.

We propose five criteria to evaluate with any lab equipment selection for CGT, including:

Performance
Qualification
GMP compatibility
Data monitoring
Flexibility

Thermo Fisher Scientific's Mary Kay Bates (Senior Global Cell Culture Scientist), Wilfredo Marin (Senior Product Application Specialist Biobanking & Cryopreservation), and Kindra Whitlatch (Product Applications Manager) will share their experiences consulting with cell and gene therapy laboratories on product selection and overcoming challenges with existing manufacturing processes and quality control.

The five criteria for selecting equipment for cell and gene therapy processes
How to know which lab equipment in your laboratory could be used when transitioning into a GMP environment
Common yet preventable mistakes related to lab equipment choice in therapeutic manufacturing
Questions to ask when selecting lab equipment for cell and gene therapy processes

Mary Kay Bates

Senior Global Cell Culture Scientist at Thermo Fisher Scientifc

Mary Kay Bates is a Senior Global Cell Culture Scientist with Thermo Fisher Scientific, where she provides cell culture and equipment expertise to colleagues and customers across laboratory and cleanroom settings. Her knowledge is based on 20 years of experience in academic and industrial cell and molecular biology labs, focusing on cancer and gene therapy. Mary Kay holds an M.S. in microbiology from the University of Wisconsin-Madison and has authored numerous publications.

Wilfredo Marin

Senior Product Application Specialist at Thermo Fisher Scientific

Wilfredo Marin is a Senior Product Application Specialist with Thermo Fisher Scientific, where he provides biobanking and cryopreservation expertise to colleagues and customers. Wilfredo's work is centered around creating innovative workflow solutions that utilize high-quality biospecimens at the highest levels of investigation. During his previous 15 years in academic research laboratories, he’s contributed to projects investigating sleep neuroanatomy, genome editing in animal models, cancer stem cells. He has also managed a pediatric rare-disease biobank. He’s authored several publications and enjoys volunteering for important biobanking committees. Wilfredo holds a BA and MS in biological sciences from Stanford University.

Kindra Whitlatch

Product Applications Manager at Thermo Fisher Scientific

Kindra Whitlatch is a Product Applications Manager at Thermo Fisher Scientific, with over 15 years of experience in laboratory equipment usage and selection. Kindra specializes in the use of equipment in the life science laboratory, including environmental chambers, microbiological incubators, and orbital shakers. Currently, she is responsible for training and supporting colleagues and customers in the appropriate use of laboratory equipment in a variety of lab spaces. She holds an MS in Molecular Biophysics and Structural Biology from the University of Pittsburgh School of Medicine and a BS in Chemistry from West Virginia Wesleyan College.