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New High Performance AEX Resin for Large Biomolecule Purification

This webcast features: Jiali Liao, Principal Scientist, Process Chromatography R&D, Bio-Rad Laboratories Large molecule purification can be difficult due to their size. This leads to slow diffusion and mass transfer kinetics of the molecules into the pores of traditional chromatography resins, which decreases their binding capacity and resolution. In this webinar, Dr. Jiali Liao will introduce the design features of the Nuvia HP-Q bead matrix that help overcome these purification challenges. Case studies on plasma protein and virus purification will…

Seamless Transition from R&D to Manufacturing

Fast and cheap: These criteria are becoming ever more urgent drivers for manufacturers of biologics, faced with increased scrutiny on the costs of developing novel drugs, the lengthy timelines for delivering these drugs to patients, and the tightening competition to capitalize on new targets. The challenge for manufacturers is further heightened by the expectations to deliver on quality as well. Although development and production of molecules such as monoclonal antibodies (MAbs) have greatly benefited from the “platformization” of core technologies…

Key Considerations for Advanced Therapies Manufacturing

This webcast features: Thomas Page, PhD, Vice President, Engineering and Asset Development, Fujifilm Diosynth Biotechnologies This technical webinar covers key considerations to support manufacturing activities from the earliest stages of cell line, viral replication platforms and/or viral vectors identification stage leading into clinical production. Having a line of sight into commercial production and the requirements leading into commercial approval are also essential for success. Key messages: Flexibility in conjunction with high containment are key for success Application of closed systems…

Setting Up a Rapid Mycoplasma Assay to Support Recombinant Protein Production

Octapharma AB (OAB) in Stockholm, Sweden, is the site for Nuwiq human recombinant factor VIII (FVIII), production. The drug is produced in a human cell line cultured in a perfusion bioreactor using a closed system (to minimize contamination) and proprietary serum-free medium without animal-derived components. In accordance with regulatory guidelines, cell banks and cell cultures used for production of biological products must be free of mycoplasma. Traditional mycoplasma testing is a growth-based method that represents a significant bottleneck in quality…

Accelerated Development, Manufacturing and Monitoring of Viral Vectors

The goals of process intensification are to enhance production while shortening timelines, lessening contamination and environmental risks to products and operators, and reducing operating footprints. Previous publications from Sartorius Stedim Biotech (SSB) have highlighted key elements of such activities. In this report, the authors extend the scope of this discussion to tools and technologies that enable intensification of viral vector manufacturing processes. The first article summarizes presentations from a 2018 seminar for viral vaccine manufacturers. Three guest presentations highlighted the…

Accelerating Biopharmaceutical Development with High-Throughput Glycan Screening and Multiple Attribute Methodology

Part 1 Development of biopharmaceuticals comprises many integrated steps, beginning with research and discovery and optimally ending with a commercial therapeutic molecule. Early screening of large numbers of clones and cell culture expression conditions is essential to identifying proteins that carry to greatest likelihood of clinical and commercial success. Part one of this report reviews how high-throughput glycan screening can significantly improve current analytical strategies relating to cell line development. Part 2 Minor impurities and changes in attributes such as…

Optimizing Unit Operations In Biopharmaceutical Manufacturing

There are many critical material-handling challenges regarding flow rates, pressure levels and the prevention of shear in the chromatography, virus filtration and TFF processes that are used in the manufacture of biopharmaceuticals. In order for these unique operations to be implemented successfully while handling fluids that can be sensitive, delicate and expensive, the operator must be aware of their specific operating characteristics and choose a pumping technology that can meet the strict demands for successful operation. While lobe and peristaltic…

Culture of 3D Cell Aggregates in Perfusion in a DASbox® Mini Bioreactor System

Three-dimensional (3D) culture systems provide cell–cell and cell–extracellular interactions that reproduce the cellular microenvironment in vivo better than typical two-dimensional monolayers. This property is of paramount importance in many applications, including disease modeling, drug toxicity assessment, and manufacturing of stem-cell–based products (1). Cultivation in stirred-tank bioreactors using perfusion mode opens up new possibilities in the cultivation of 3D cell aggregates. Perfusion allows for removal of detrimental metabolites, cell debris, and proteases from the culture as well as the addition of…

Updating Biologics Manufacturing: Using Modern, Single-Use Powder Handling Reduces Time to Market and the Chance of Contamination

Biopharmaceutical companies are striving to produce biologics more efficiently with a lower cost point and fewer employees. Most small-scale media and buffer operations are carried out with small bottles of liquid media. But as processes are scaled up to manufacturing levels, that is no longer a viable option. Costs of shipping liquid are simply prohibitive, so the industry has migrated to using media and buffer in powder form. In fact, 90% of cell-culture media and buffer for sale is now…

Biopharmaceutical Production in Fed-Batch CHO Cell Culture

Chinese hamster ovary (CHO) cells are used widely in the biopharmaceutical industry for the production of recombinant proteins. In times of rapid growth in the biopharmaceutical market with monoclonal antibodies (MAbs) and biosimilars, the use of chemically defined (CD) feeds and culture media for CHO mammalian cell culture is crucial. Currently, strict regulatory norms for the biopharmaceutical industry has led to the wide use of animal-component–free (ACF) culture processes, including CD media and feeds. A business requires significant amounts of…