Creating a Closed Process Semi-Automated Workflow for Human MSC Expansion, Harvest, and Final Fill.

Learn how to perform a closed-system MSC expansion process in standard BSL-2 lab settings. This webinar will demonstrate use of off-the-shelf consumables in a closed, semi-automated modular workflow as an alternative, more cost-effective approach compared to “all-in-one” systems.

Register Free: https://www.biopharminternational.com/bp_w/human-msc-expansion

Event Overview:

Costly all-in-one cell processing systems are commonly used in the development and production of cell and gene therapies. Large scale production of these therapies requires bioreactors to generate enough biological material, with reproducible and aseptic workflows, often warranting precious and costly clean-room space. While commercially available bioreactor platforms allow for large scale production of cell therapies, they are often limited in scaling processes, are inherently inefficient, require skilled personnel, and lack flexibility. Employing a decentralized manufacturing strategy, cost-effective production of advanced therapeutics using modular closed-system production workflows may be achieved at a fraction of the cost of all-in-one systems. This presentation describes the results of expanding bone-marrow derived mesenchymal stem cell (bMSC) on Corning CellBIND microcarrier beads in a modular closed-system. The workflow was assembled using specialized single-use off-the-shelf bioprocessing consumables from Entegris, Chemglass rocking bioreactor modules, and the BioLife Signata CT-5 liquid-handling system. The modular workflow allowed for closed-system processing over multiple steps, including bioreactor MSC expansion, aseptic culture monitoring, cell-microcarrier detachment, and final filling. The entire workflow was arranged and performed on a single table in a standard BSL2 laboratory. Samples were collected aseptically daily for seven days, and over this period three population doublings were recorded. The study results indicate that this modular system is suitable for both suspension and adherent cell growth, capable of scale up and scale out from lab to commercial levels.

Key Learning Objectives:

• Closed system hMSC growth and recovery
• Use of off-the-shelf consumables
• Setup of semi-automated modular workflows

Who Should Attend:

• MS&T Engineers/Scientists (Manufacturing Science & Technology)
• Process Development Engineer/Scientists
• Associate/Senior Director of Process Sciences and Manufacturing

Speakers:

Kyle Harvey, PharmD, PHD
Research Scientist in Regenerative Medicine
MED Institute Inc.

Kyle Harvey is a Research Scientist for the Regenerative Medicine Team at MED Institute. Kyle graduated from Purdue with his PharmD in 2016. He then continued his education at Purdue to pursue a PhD in Molecular Pharmacology, which he completed in the Fall of 2022. His dissertation was focused on discovering the mechanisms by which calcium channels contribute to pancreatic beta-cell function. After completing his Ph.D, Kyle joined the MED Institute Team in the Fall of 2022 and leads the Regenerative Medicine team.

Donnie Beers
LS Applications Leader - Cell and Gene Therapy
Entegris Inc

Donnie has nearly 15 years’ experience working in single-use and automation technology in biopharma. Donnie joined Entegris in 2019 as Sr. Product Manager for single-use products and has since taken a lead role in helping customers overcome unique challenges in cell and gene therapies. He has previously held roles in Engineering management, project management, and manufacturing within a cGMP environment. Donnie earned his BSc. in Biochemistry from University of Wisconsin – Madison.

Register Free: https://www.biopharminternational.com/bp_w/human-msc-expansion