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New Genderless Sterile Connection Technology – A Quality By Design (QbD) Approach For Greater Sterility Assurance From Manufacturing To Use

Single-use pre-sterilized systems can potentially offer a higher level of sterility assurance and a lower risk of product contamination by eliminating some of the operational procedures of traditional processing. The importance of this benefit was highlighted by the FDA’s product recalls in 2015 where 78% of recalls were attributed to lack of sterility assurance or to contamination of the drug product, with the primary reason being failure to follow written procedures. A key requirement for multi-component, single-use sterile systems is…

How to Boost Profits with Single-Use Powder Transfer in Biopharmaceuticals Manufacturing

For many years, media and buffer ingredients used in powder form were transferred from stock containers using open scoops, weighed and mixed in buckets or open-top bags, and then carried in and dumped from those buckets or open-top bags directly into production vessels—based on the premise that sterility wasn’t required at that early stage of manufacturing. While much of this process was often carried out in a separate room from the production line to contain airborne contaminants, final transfer to…

Getting Big Benefits from Small Components

Like a chain, a biopharma transfer system depends on each of its links being strong enough to protect the integrity of the materials being transferred. In order to prevent problems associated with contamination, the system must be able to maintain a pure environment. Container closures and stopper systems are sometimes seen as small items, but choosing the right components is vital. The impact of specifying the appropriate closure or stopper system can be felt throughout an entire fluid transfer process.…

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…

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…

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)…

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…

Future Immunoassay Approaches in Modern Bioprocess Development

Modern bioprocess development requires accurate, high throughput analytical methods to match scaled-down, high-throughput screening, the application of DoE, and science-based decision making consistent with QbD. Gyrolab™ systems and Gyros’ immunoassay kits constitute a proven platform that supports these needs today and has the capability to meet future challenges. The assay principle uses high-capacity, flow-through affinity columns embedded within a CD. Centrifugal force, capillary action and hydrophobic barriers are exploited during parallel processing of up to 112 samples on each CD.…

Applying Single-Use Efficiencies to Room-to-Room Fluid Transfer

Biopharma manufacturers need to transfer critical fluids from cleanroom to cleanroom quickly, aseptically, and with minimal effort and expense for maximum productivity. Traditional hard piping involves intensive cleaning operations and down time between uses. Portable tanks run the risk of damage and leaks and also present cleaning challenges. Incorporating Single-Use components and practices with in-wall transfer systems can help speed and streamline operations while maintaining isolated environments. These types of systems help remove the risk of breakage, spillage and lost…

Development and Optimization of CHOgro® Transient Expression Technologies for High Titer Antibody Production in Suspension CHO Cells

During early stage drug development, quickly obtaining relevant candidate proteins through transient transfection can accelerate drug discovery. High titers are often obtained from Human Embryonic Kidney (HEK) 293 derived cell types; however, the use of different host cells between early stage transient and later stable protein production is a concern and can lead to the advancement of false-positive candidates. Chinese hamster ovary (CHO) cells are a desirable target cell type due to growth characteristics and a history of regulatory approval;…