BPI White Papers

Modern Peptone Manufacturing: Raising the Standard for Fermentation Substrates

Peptones from the Solabia Group represent the result of nearly 50 years of strategic activity and savoir-faire. As key components in industrial fermentation, they contribute to a range of products, from probiotics and vaccines to specific bacterial metabolites in cosmetics. Although they are often perceived as replaceable commodities with similar sounding names, that misconception can lead to significant problems. Peptones differ in sourcing as a function of a producer’s manufacturing experience, raw materials, and (most important) production site itself and…

TOYOPEARL NH2-750F: Flow-through Removal of Endotoxin

Endotoxins are remnants of bacterial cell walls that may contaminate drug products and cause an immunogenic response. They are often referred to as “pyrogens” due to their fever-inducing effects. Endotoxins may be found in drug products either due to contamination from host cells used to produce a drug product in a bacterial expression system or due to adventitious bacterial contamination in non-microbial products. Thus, endotoxin clearance is a requirement of downstream processing of biologics, especially those derived from microbial expression…

A comparative study of MiniTEM™ versus DLS Zetasizer Nano and NTA NanoSight NS300 performance when analyzing < 50 nm particles

Characterization and analysis of subvisible particles of biological origin can be challenging or give insufficient information. In this study Adeno associated virus (AAV) particles contaminated by host cell proteasomes are analysed with direct versus indirect methods performed in a standard laboratory setting to reveal the difference in performance and quality of the information obtained. The focus is on the ability to detect the AAV particles of interest and distinguish them from the contaminating proteasomes. The compact, tabletop MiniTEM system enables…

Ten Tips for Single-Use Biopharmaceutical and Pharmaceutical Tubing Selection

Tubing for Single-Use bioprocess and pharmaceutical applications has particular requirements. Among them are the ability to withstand various sterilization processes, the delivery of favorable test results regarding extractable substances, and the absence of animal-derived ingredients. Flexibility, permeability, performance in pumps, and welding and sealing capabilities are also common considerations. Additionally, these critical industries should be aware of the environment in which the tubing is manufactured, association standards that must be met and costs. One of the most important concerns involves…

Solving Viscosity in Automated Particle Imaging

Micro-Flow Imaging™ (MFI) easily detects particle size and morphology on a wide range of particle contaminants. And when you add the Bot 1 Autosampler to your MFI 5000 Series system, you’ve got the automated go-to method of choice for particle analysis today. Together, this combination lets you quickly screen for any changes in levels of particle contaminants like protein aggregates and silicone oil in your biopharmaceutical formulation. Highly concentrated protein solutions can be a little trickier to analyze with other…

Objective characterization of liposomal drug delivery platforms: Using cryoTEM and designated image analysis software

Quality-critical attributes particular to liposome drug products include physicochemical properties such as particle size distribution and morphology, e.g. their overall shape. Such properties will influence the biological activity and bio-distribution of liposomal-based drug and gene delivery platforms. Analytical techniques that provide objective and reliable information on liposome particle characteristics can thus help to improve product development processes and shorten the time to securing their final quality. Cryo-transmission electron microscopy (cryoTEM) combined with image analysis using proprietary Vironova Analyzing Software (VAS)…

Understanding Single-Pass Tangential Flow Filtration and the New Era of Bioprocessing

Learn how single-pass tangential flow filtration (SPTFF) technology is revolutionizing current and future bioprocessing platforms with its implementations in biotech, vaccine and plasma industries. Adopting SPTFF at process development (PD), pilot, clinical and commercial manufacturing scales has major advantages over conventional approaches. Key benefits include flexible manufacturing, reduced processing volumes, high product recoveries and increased yield, as well as major savings in capital expenditures. SPTFF also enables disposable and/or single-use technology utilization.

CHO Cell Cultivation in the Allegro™ XRS 20 Bioreactor System with Working Volumes from 2 to 25 L

  The Allegro™ XRS 20 bioreactor system is a single-use bioreactor technology designed for applications ranging from general life sciences research to seed train operations, and as a final stage reactor for small scale commercial production. In practice, many installed systems have been implemented into seed train and small scale GMP production operations, where operational simplicity and consistent results are key benefits for industrial users. In the application note summarized here, we report efforts to enhance the capabilities of the…

Pall SoloHill® Animal Protein-Free Microcarriers for Dengue Virus Production

Pall Life Sciences offers a variety of regulatory-friendly animal protein-free (APF) SoloHill® microcarriers that can be quickly and easily optimized for use in vaccine production platforms. Our application note describes dengue virus production in Vero, optimizing cell culture seeding densities and microcarrier working concentrations for efficient cell attachment and growth in two different cell culture media platforms: a traditional serum supplemented formulation and a commercially available serum-free formulation (SFM). Overall, the results of this study demonstrates that Pall APF microcarriers…

Taking Advantage of High Capacity Protein A: An Economic Comparison of the Resin Cost Per Gram of Antibody Produced

With pressures mounting to reduce production costs at many companies, and protein A being the most expensive resin used in mAb purification, the use of a high capacity protein A resin can significantly impact the overall cost of doing business. This report details how using a high capacity protein A resin will reduce production costs, on a per-gram produced basis, for companies that implement its use in their chromatography platform.