BPI White Papers

Efficacy and Utility of New EXP-Pak Closed-System Disposable Cell Expansion Bags Designed for Cell Therapy Applications

Clinical cellular therapy applications often times require a cell expansion or maturation step prior to use. Traditionally, cell expansion or cell culture is performed in “open” systems including multi-well culture dishes or tissue culture flasks. These “open” steps present risks and are not ideal for larger-scale manufacturing. The new EXP-Pak™ cell expansion container offered by Charter Medical, Ltd. is a closed-system, gas permeable bag intended for expansion and culture of non-adherent cells. The data demonstrate that the EXP-Pak™ cell expansion…

Freeze-Pak STS

Freeze-Pak™ STS Bio-Containers and STS Shippers: Offering a New Single-Use Solution for Frozen Storage and Transport to -80°C

Frozen storage is commonly achieved with single-use containers and enables manufacturing process flexibility, long-term product stability and minimizes logistics challenges.  While single-use containers are available for storage and transport of frozen products, some require a significant investment while others don’t offer the necessary support and protection. Charter Medical has recently developed a new single-use frozen storage and transport shipping solution designed to complement the single-use Freeze-Pak™ STS (FP-STS) bio-containers which were engineered specifically for frozen storage applications. The bags and…

Evaluation of HCP and DNA Clearance with NatriFlo™ HD-Q Membrane Adsorbers at Lab to Process Scales

NatriFlo™ HD-Q chromatography from Natrix Separations introduces reliable and reproducible Q polish performance that combines resin binding capacity with adsorber speed to achieve a new level of process flexibility. Gallus Biopharmaceuticals (a St. Louis based CMO) evaluated NatriFlo™ HD-Q membrane columns as an anion exchange polishing step with the objective of assessing NatriFlo’s ability to (1) reduce process-derived impurities to achieve target product profile; (2) maintain process robustness to process changes; and (3) achieve reliable scalability from lab to production.…

TOYOPEARL NH2-750F Aggregate Removal from Monoclonal Antibodies

The drive to reduce the manufacturing costs for biological therapeutics have increased the demands placed on downstream unit operations to the point where a single processing step is expected to accomplish a multitude of purification objectives. Where anion exchange resins have traditionally been used to remove DNA, endotoxin, and as a viral clearance step in the purification of monoclonal antibodies (mAbs), new ligand chemistries make it possible for anion exchange chromatography to do more. In the following paper, TOYOPEARL NH2-750F,…