Jennifer Chain

Jan 9, 2025 | cellandgene.com | Jennifer Chain

By Jennifer Chain, Ph.D., CABP, Consultant, CSM Consulting LLC A significant portion of the cell therapy field asserts that good manufacturing practice (GMP) begins with the isolation of cells from the starting material source, like the leukopak, bone marrow aspirate, or umbilical cord tissue. However, there’s a growing movement, and I count myself as part of it, that believes GMP begins much earlier than that.

Jan 9, 2025 | outsourcedpharma.com | Jennifer Chain |Louis Garguilo

By Jennifer Chain, Ph.D., CABP, Consultant, CSM Consulting LLC A significant portion of the cell therapy field asserts that good manufacturing practice (GMP) begins with the isolation of cells from the starting material source, like the leukopak, bone marrow aspirate, or umbilical cord tissue. However, there’s a growing movement, and I count myself as part of it, that believes GMP begins much earlier than that.

Nov 25, 2024 | outsourcedpharma.com | Jennifer Chain |Louis Garguilo

By Jennifer Chain, Ph.D., CABP, Consultant, CSM Consulting LLC Two major supply chain challenges for allogeneic cell therapy are the quality and reliability of cellular starting materials used in manufacturing. Previously, I explored factors influencing starting material quality and its impact on therapy manufacturing and efficacy.1 This article focuses on the reliability of starting materials, particularly leukopaks, and proposes a fundamental solution to this issue.

Nov 25, 2024 | cellandgene.com | Jennifer Chain

Get more Cell & Gene insight with our FREE newsletter Guest Column | November 25, 2024 By Jennifer Chain, Ph.D., CABP, Consultant, CSM Consulting LLC Two major supply chain challenges for allogeneic cell therapy are the quality and reliability of cellular starting materials used in manufacturing.

Nov 25, 2024 | bioprocessonline.com | Jennifer Chain

By Jennifer Chain, Ph.D., CABP, Consultant, CSM Consulting LLC Two major supply chain challenges for allogeneic cell therapy are the quality and reliability of cellular starting materials used in manufacturing. Previously, I explored factors influencing starting material quality and their impact on therapy manufacturing and efficacy.1 This article focuses on the reliability of starting materials, particularly leukopaks, and proposes a fundamental solution to this issue.