Single Use

BioProcess Insider Interview: Dr. Ger Brophy, Avantor

Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider. Featuring: Dr. Ger Brophy, Executive Vice President, Biopharma Production, Avantor. Avantor has expanded its biopharmaceutical capabilities significantly over the past year. In addition to opening facilities in The Netherlands and Massachusetts for manufacturing and distribution of single-use systems, respectively, the company has broken ground on sites in Ireland and Singapore. Avantor also acquired Masterflex, a manufacturer of peristaltic pumps and fluid-handling solutions. Brophy explained that such activity exemplifies Avantor’s efforts to increase…

Advancing Biomanufacturing Capabilities with a Next-Generation Single-Use Solution

Charles Heise, senior staff scientist in bioprocessing strategy and development group, Fujifilm Diosynth Biotechnologies. Heise presented work Fujifilm Diosynth Biotechnologies has done to debottleneck downstream processes for continuous operations and high-titer product batches. He highlighted the benefits of automation and data management, closed processing, and advanced buffer management — all together in the SymphonX system. A disposable flow path provides buffer-management capability through standard software for “multifunctional” operations. The company wanted one “rig” to perform all the necessary downstream functions,…

Reflections on the Evolution of Biopharmaceutical Manufacturing: A Virtual Roundtable with Scientists from Sartorius

As a trusted partner in the life-sciences industry, Sartorius has contributed significantly to the evolution of biopharmaceutical manufacturing. To reflect on the rich history of the industry, we arranged a virtual roundtable. Based on shared questions, we corresponded about what we considered to be the most important scientific, technological, and operational developments in the past 20 years of bioprocessing. We also reflected on the emergence of new modalities and how such products are likely to shape the future of the…

Intensifying Bioprocessing: Profiling 20 Years of Advances Driven By Single-Use Technologies

A long-time editorial advisor for BPI, Miriam Monge is head of marketing for fluid-management technologies (FMT) at Sartorius, where she works to develop sustainable growth strategies for single-use bioprocessing. Over the past 20 years, she has played a significant role in championing development, promotion, analysis, and adoption of single-use technologies (SUTs). We asked her to share her experiences and to offer additional thoughts about current and future industry trends. Science and Technology From a technological perspective, without a doubt, I…

The Coevolution of the Single-Use and Biopharmaceutical Industries: Company and Industry Reflections from Colder Products Company (CPC)

Single-use technology (SUT), specifically its evolution from clinical applications to commercial production, has made a remarkable impact on bioprocessing. SUT flexibility and sterility have helped to build a strong foundation for manufacturers to initiate production of many different drugs quickly and cost-effectively, including vaccines and cell and gene therapies (CGTs). Single-use systems make it economically feasible to manufacture therapies for diseases that affect relatively small patient populations — the kinds of numbers that might not justify an investment in a…

Pushing the Boundaries of Innovation: Advancing Single-Use Technologies and Supports for Bioprocess Fluid Management and Cold-Chain Operations

The evolution of single-use technologies (SUTs) is among the most important developments during the past 20 years of biomanufacturing. Large stainless-steel containers have long been used for storage and cooling of drug substances. However, there has been a shift toward SUT, which has enhanced manufacturing agility and flexibility. Establishment of single-use systems also has built a solid foundation upon which to improve production of several types of biopharmaceuticals, including mRNA, allogeneic cell therapies, and viral-vectored gene therapies. Especially for emerging…

Certified Reference Mixtures in Extractables Screening of Polymeric Materials: For Container–Closure Systems and Single-Use Equipment

Plastics have been used for decades in container–closure systems (CCS) for drugs and in single-use (SU) manufacturing equipment for biopharmaceutical processing. Biomanufacturers must comply with national and international laws and regulations that require proof that use of such polymeric materials is safe (1, 2). That necessitates testing for potential biological responses and interactions with drug substances. Comprehensive extractables and leachables (E&L) studies also are required for potential release of undesired compounds from polymers. Extractables tests are performed on materials under…

Cold Chain Excellence: Getting Control Over Freezing of Biologics

HOW CONTROLLED FREEZING ENABLES SCALABILITY: Controlling the freezing behavior of drug substance is the ultimate goal in pharmaceutical manufacturing. It opens doors to process reproducibility, consistent quality of the final drug product by maintaining uniform conditions for the biopharmaceuticals during freezing and consequently for frozen storage and shipment. As one of the most essential parameters to achieve control over freezing & thawing bulk, the freezing rate has been considered and evaluated in different tests. The leverage of the ice front…

Advancing Logistics for ATMP Manufacturing

Advanced therapy medicinal products (ATMPs) hold much potential for improving healthcare. They offer hope for treating or even curing patients. The biopharmaceutical industry has recognized the importance of making such therapies accessible to as many people as possible. To provide personalized ATMPs, biomanufacturers are shifting toward flexible, patient-centered production processes. A Paradigm Shift in ATMP Manufacturing Ex vivo cell and gene therapies are particularly promising approaches to personalized regenerative medicine. Thus, it is no surprise that the numbers of US…

Increasing the Integrity of Closed Systems: Advantages Offered by Single-Use Connectors

Due to the complexity of biologic development and manufacturing and the business pressures of the biopharmaceutical industry’s landscape, the margin for error in today’s industry is small. That is why minimizing the threat of contamination is critical when using a closed system for drug development and manufacturing. Yet the traditional method of connecting each step in a closed process can present other risks to the integrity of your product. Therefore, it is important for you to be confident in selecting…