Single Use

Container Materials for Biopharmaceuticals: A Comparative Small-Scale Case Study of Stainless Steel and a Proprietary Nickel-Based Alloy

Evaluating compatibility of a drug substance with all surfaces that it might come into contact with during drug product manufacturing is essential to ensure product quality. Proteins can adsorb to contact surfaces, form aggregates, and desorb into a drug-substance solution. Proteins also can degrade in presence of leachables generated from contact surfaces during manufacturing. Containers and vessels used during manufacturing are single-use disposable components or metal tanks, primarily either 316L stainless steel (SS) or C-276 Hastelloy nickel-based alloy (HLY). Researchers…

Ensuring Single-use Systems Integrity in Aseptic or Closed-Process Applications

Due to their numerous benefits, single-use systems (SUS) have been increasingly implemented in biopharmaceutical processes in the past decades. Originally used in applications for the preparation and storage of buffer and media, SUS have become more and more important in the commercial production of biopharmaceuticals. Today, biopharmaceutical manufacturers use this technology in critical drug substance or drug product process steps such as formulation, bulk storage, bulk transport, and final filling of drug product. By using single-use technologies, manufacturers can reduce…

Advanced Liquid Transfer with Single-Use Systems

Most biopharmaceuticals are manufactured in large-scale stainless-steel piping and vessels, with downstream processes taking place within rigid and inflexible facilities. Although process steps such as harvest, purification, fermentation, filtration, dispensing, and freezing require flexibility, stainless steel has not been replaced yet by single-use systems at a large scale. However, manufacturers wanting to optimize process efficiency and scalability to obtain a viable and valuable product for commercial use inevitably will need single-use technology. Aseptic fluid management with single-use systems offers numerous…

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…