BPI White Papers

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.

ThawSTAR™ Automated Cell-Thawing System: Breakthrough Adaptive Sensing Technology for Reproducible, Standardized Cell Thawing

Advances in cryopreservation techniques have been crucial for the substantial progress achieved in many fields, including cell biology research, drug discovery, bio-banking, and assisted reproduction. While cryopreservation techniques have markedly improved, downstream cell thawing techniques have thus far been neglected, even though proper thawing of cryopreserved materials is essential for optimal cell viability. The success of high-promise fields such as cellular therapy and regenerative medicine require reproducible and standardized handling of the therapeutic cells, which includes thawing both during manufacturing…

Safety Considerations for Gas Filtration in High-Temperature and Oxygen Enrichment Applications

Gas filtration using sterilization-grade filters is a key part of the production, manufacturing and packaging process of biopharmaceuticals and other products. While it may seem a simple step, there are major safety considerations that have to be taken in to account to protect staff, equipment and facilities from hazard, particularly when working in high temperature and oxygen enrichment applications. This paper examines the safety issues involved, looks at material design considerations and introduces a ready-made solution for safe, effective, robust…

Monoclonal Antibody Production: Viral Clearance and Host Cell Protein Reduction Using a High Capacity Single-Use Strong Anion Exchange Device

Strong anion exchange (Q) chromatography is an industry standard for polishing purification steps of mAb production. It is a proven technology which removes viruses, and host cell proteins from process feed streams in flow through mode. NatriFlo HD-Q devices adsorbers feature a hydrogel membrane which combines high dynamic binding capacity and salt tolerance to deliver best-inclass performance. This makes it possible to rapidly process large sample volumes using a small disposable device. This article examines the ability of NatriFlo HD-Q…

Monitoring Protein Unfolding and Refolding

Proteins exist in a highly ordered, folded state. This highly ordered structure of a protein is integral to the efficacy and safety of a protein-based biotherapeutic. Protein unfolding and refolding are an indicator of protein stability. As a protein begins to unfold, the hydrodynamic radii of the protein species change. Denaturation of proteins may range from slight and reversible conformational changes to a drastic loss of solubility, leading to irreversible aggregation. Monitoring the stability of the different protein conformations is…

Changing Column Packing from an Art into a Science

Chromatography is often the most critical step in biopharmaceutical downstream processing because of its role as the engine for separating impurities from target biologics. The most demanding operation in production scale chromatography is typically packing the column in a way that ensures first time success and a validation result which meets the batch record standards. Traditionally column packing has been the responsibility of a few specialist operators and has been regarded almost as an art by most observers. When the…

Monoclonal Antibody Production: Viral Clearance and Host Cell Protein Reduction Using a High Capacity Single-Use Strong Anion Exchange Device

Strong anion exchange (Q) chromatography is an industry standard for polishing purification steps of mAb production. It is a proven technology which removes viruses, and host cell proteins from process feed streams in flow through mode. NatriFlo HD-Q devices adsorbers feature a hydrogel membrane which combines high dynamic binding capacity and salt tolerance to deliver best-inclass performance. This makes it possible to rapidly process large sample volumes using a small disposable device. This article examines the ability of NatriFlo HD-Q…

The Effect of Membrane Selection and Operating Parameters on Sterile Filtration of Hyaluronic Acid

Hyaluronic acid (HA)-based solutions are traditionally difficult to filter, due to their high viscosity. Many users have found sterile filtration of hyaluronic acid solutions very challenging to implement, from both an economical, as well as a practical standpoint. This White Paper evaluates commercially-available sterilizing-grade products for filtration of HA and explains how sterilizing-grade filters can offer a highly efficient, economical solution even under the worst-case bacterial challenge conditions. It outlines how the combination of various properties of HA-based solutions and…

Best Practices For Successful Filter Integrity Testing Using The Water Intrusion Test (WIT) Method

Hydrophobic filter cartridges which utilize sterilizing-grade polyvinylidene fluoride or polytetrafluoroethylene membranes are widely used in the pharmaceutical industry to sterilize compressed air or gases for product contact, as well as acting as sterile tank vents. However, hydrophobic membranes can also make filter integrity testing in situ difficult, as the membrane must be fully wetted prior to testing by the widely accepted integrity test methods of Bubble Point and Forward Flow. The Water Intrusion Test (WIT) is widely accepted within the…

Secondary Packaging: Creating Value with Product Lifecycle Management

with Daniela Guttmann and Susanne Hall Increasing regulatory requirements combined with the market pressure to develop patient-friendly drug delivery systems make product lifecycle management (PLM) a decisive field for today’s pharmaceutical and biotechnology companies. Their strategic service providers also are affected by those conditions. For example, as an internationally operating contract development and manufacturing organization (CDMO), Vetter reports an increasing number of life-cycle management projects with its customers in the past years. Learn more in this white paper from Vetter.…