Joe Leuser

Apr 25, 2024 | pharmaceuticalonline.com | Mark Witcher |Scott Merz |Asahi Kasei Bioprocess |Joe Leuser

In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules. Constraints And Solutions For Biopharmaceutical ManufacturingDissect the reasons for capacity bottlenecks stemming from process development scope, downstream chromatography, and equipment constraints, and delve into the potential solutions associated with each.

Mar 21, 2024 | cellandgene.com | Evan Hagen |Joe Leuser

Stem cells are the backbone of many allogeneic therapies and where they come from affects development and supply chain logistics, particularly cryopreservation. What temperatures are ideal to maintain product potency? How do you build a reliable cold chain? How do you work with existing infrastructure to allow for an “off-the-shelf” therapy? Don’t miss the next Cell & Gene Live digital event! Registration is free thanks to the support of Charter Medical and Bio-Techne.

Feb 20, 2024 | pharmaceuticalonline.com | Joe Leuser

Article | February 20, 2024 By Joe Leuser, Associate Director, Asset Management & Reliability The article suggests a risk-based approach to calibration in line with the International Society of Pharmaceutical Engineers (ISPE) Good Automated Manufacturing Practice (GAMP) guidelines. This aligns with the FDA's initiative of a risk-based approach to GMP focusing on product quality and public safety risks.

Feb 20, 2024 | cellandgene.com | Joe Leuser

Article | February 20, 2024 By Joe Leuser, Associate Director, Asset Management & Reliability The article suggests a risk-based approach to calibration in line with the International Society of Pharmaceutical Engineers (ISPE) Good Automated Manufacturing Practice (GAMP) guidelines. This aligns with the FDA's initiative of a risk-based approach to GMP focusing on product quality and public safety risks.

Feb 20, 2024 | wateronline.com | Joe Leuser

Article | February 20, 2024 By Joe Leuser, Associate Director, Asset Management & Reliability access the Article! Get unlimited access to: Trend and Thought Leadership Articles Case Studies & White Papers Extensive Product Database Members-Only Premium Content Welcome Back! Please Log In to Continue. X Enter your credentials below to log in. Not yet a member of Water Online? Subscribe today.