2018

The Effect of Albumin on Viability in Stem Cell Therapy

by and

Stem cell therapies are some of the most cutting-edge and sophisticated therapeutic developments. They offer an attractive alternative approach to more widely used treatments for conditions such as multiple sclerosis, metabolic diseases, cardiovascular disease, liver disease, and cancer. But developers still face challenges, some of which can be addressed by the use of recombinant human albumin. As a long-established ingredient of cell culture media, albumin is well recognized for its ability to facilitate growth of many cell types. The industry is expanding its use of high-quality, fully recombinant, current good manufacturing practice…

September 15, 2018

In-Line Turbidity Sensors for Monitoring Process Streams in Continuous Countercurrent Tangential Chromatography (CCTC)

by , , and

A strong connection between turbidity and total suspended solids (TSS) has been linked in the past to measuring well defined particles in processes. Optical density probes have seen wide adoption in the biotechnology industry for monitoring cell growth within a bioreactor, whereas in-line turbidity sensors have been used to monitor filter performance. Turbidity measurements offer a rapid quantification of suspended solids but have not been used in the biotechnology industry for chromatographic resins. In this study, turbidity measured with equipment developed by PendoTECH was used with novel continuous chromatography technology developed by Chromatan…

September 15, 2018

Single-Use Bioreactors: Performance and Usability Considerations, Part 2

by , , and

As the biopharmaceutical industry continues toward streamlined bioprocessing and intensified cell-culture biology, selection criteria of single-use bioreactors (S.U.B.s) and other bioprocessing technologies will become increasingly rigorous, emphasizing the importance of considering every aspect of technologies under evaluation. In part 1, we discussed performance for process control, including the maintenance of critical process parameters (CPPs), and highlighted bioreactor performance (e.g., mass transfer, power per volume, and temperature control) as a critical consideration during the selection of S.U.B.s (1). Part 2 focuses…

September 15, 2018

Designing Laboratories for Flexibility and Collaboration

by

The blockbuster business model may have paid off in the past, but tomorrow’s biopharmaceutical successes will depend more on rapid and diverse discovery than on any single breakthrough. In the race to get new therapies from research and development (R&D) into pharmacies, next-generation laboratory space could become a game-changer. Blockbuster drugs typically were made in industrial laboratories — and industrial-strength measures were required to reconfigure those spaces as new research priorities emerged over time. Facing changing patient needs and ongoing…

September 15, 2018

Seamless Transition from R&D to Manufacturing

by , , , , , , , , , and

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…

September 14, 2018

Setting Up a Rapid Mycoplasma Assay to Support Recombinant Protein Production

by

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…

September 5, 2018

Accelerated Development, Manufacturing and Monitoring of Viral Vectors

by

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…

August 29, 2018

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

by

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…

August 28, 2018

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

by , , , and

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…

August 24, 2018

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

by , and

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…

August 24, 2018