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,…

The Importance of a One-Stop-Shop-6 Questions to Ask Your Fluid Management Component Supplier

A one-stop-shop fluid management component supplier assures quality, streamlines processes, and limits costs. To be certain you receive the preeminent and safest single-use component, take time to evaluate your fluid-management supplier or a supplier under consideration by asking the 6 important questions we pose in this whitepaper. Your supplier’s answers will help determine if the company is a steadfast partner and one-stop-shop committed to helping you pass FDA validation. You also will learn your supplier’s willingness to provide: the best…

A versatile high capacity, single-use chromatography tool with superior salt tolerance, process robustness and impurity removal

Strong anion exchange (Q) chromatography has become an industry standard in the polish purification steps of mAb production. It is a proven technology to remove DNA, viruses, endotoxins and acidic host cell proteins from process feed streams in flowthrough mode. As the industry pursues an increasing interest in downstream single-use technologies and flexible biomanufacturing due to advancements in cell culture technology and the emergence of cost-sensitive biosimilars, conventional purification technologies present limitations. Despite their high binding capacity, traditional resin-based chromatography…