Reliable access to high-quality starting material is a primary challenge in cell therapy manufacturing. Freshly isolated leukopak starting materials depend on donor availability and are vulnerable to cell losses from scheduling changes and other unforeseen circumstances. Flexibility often is required for cell therapy manufacturing. Therefore, relying solely on freshly isolated starting material is impractical, particularly when cell therapy logistics involve global shipping and distribution. Donor sourcing is among the most critical factors shaping cell and gene therapy (CGT) supply chains.…
Author Archives: Dominic Clarke
Development of a Novel Cold Chain Tubing, FP-FLEX™, and Single- Use Freezing Bag for Working Cell Banks Enabling Closed-System Processing to Temperatures as Low as -196°C
Working cell banks (WCB’s) are commonly applied to initiate cell culture manufacturing campaigns for production of therapeutic proteins. These campaigns typically begin with inoculation of cells previously cryopreserved in vials. While vials are typically used to establish WCB’s and initiate manufacturing campaigns, they are not optimal for the growing demands of commercial production. Vials are small and filling/removal is performed through an open cap. This process leads to numerous manual operations and culture vessels, resulting in contamination risks and potential…
Development of a Novel Cold-Chain Tubing, FP-FLEX™, and Single-Use Freezing Bag: For Working Cell Banks Enabling Closed-System Processing to Temperatures As Low As –196 °C
Working cell banks (WCBs) are commonly applied to initiate cell culture manufacturing campaigns to produce therapeutic proteins. Those campaigns typically begin with the inoculation of cells previously cryopreserved in vials. Although vials are typically used to establish WCBs and initiate manufacturing campaigns, they are not optimal for the growing demands of commercial production.
Establishing Strategic Supplier Partnerships to Facilitate Manufacturing Success
In November 2009, Talecris Biotherapeutics announced an ambitious US$269 million expansion of its Clayton, NC, manufacturing facility. The company was subsequently purchased by Grifols, Inc. in 2011. Constructing a new facility with a state-of-the-art manufacturing process intended to generate clinical products involves top-notch project management, exceptional fortitude, and numerous supply chain decisions. Suppliers are often relied on to provide standard product support. When used effectively, they can be an invaluable resource beyond basic services. Additional support may include…
New EXP-Pakâ„¢ Closed-System Disposable Cell Expansion Bags
Clinical cellular therapy applications often times require a cell expansion or maturation step before use. Traditionally, cell expansion or cell culture is performed in “open†systems including multiwell culture dishes or tissue culture flasks. These “open†steps present risks and are not ideal for larger-scale manufacturing. The new EXP-Pakâ„¢ cell expansion container is a closed-system, gas permeable bag intended for expansion and culture of nonadherent cells. EXP-Pakâ„¢ bags are made from a unique polyolefin film that permits…