Manufacturing

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…

Reflections on 20 Years: A Conversation with Yposkesi’s Chief Technical Officer

Brian Mullan joined Yposkesi, an SK pharmteco company, as its chief technical officer in 2020. With over 20 years of experience, he has held leadership roles in late-phase process development, product launch, and commercial supply for large pharmaceutical companies making therapeutic monoclonal antibodies (MAbs). In eight years at Novartis, Mullan held posts as head of manufacturing science and technology and as a global technical project leader. From 2008 to 2012, he was process technology-transfer lead at Eli Lilly and Company.…

Global Excellence in Biomanufacturing: Fueled by 150 Years of Creating Value Sustainably

Rentschler Biopharma began its role as a contract development and manufacturing organization (CDMO) for biopharmaceuticals in 1997. Founded in 1872 as a pharmacy in Laupheim, Germany, the company transitioned to pharmaceutical manufacturing, then branched out into biotechnology, and ultimately channeled its expertise and experience into becoming a global CDMO. Our success over the past 150 years has been based on a strong foundation of creating value sustainably, and that has paved the way for further advancement and success. As a…

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…

Advanced Materials in Bioprocessing

The choice of materials to develop and process biopharmaceutical products has a significant influence on the quality and purity of those products. Biomanufacturers have benefited from their use of both stainless-steel and single-use materials for individual process components and entire process systems. But careful attention must be paid to material characteristics. Working with different single-use plastics, for example, means that biomanufacturers must take product-contact issues into account, including the risk of extractables and leachables. To celebrate its 20th anniversary, BioProcess…

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…

Biomanufacturing from 2002 to 2022: How Far the Biopharmaceutical Industry Has Come

It has been two decades since the theatrical release of the first Spider Man film with Tobey Maguire, the euro became the official currency for the European Union, and Anne Montgomery and Cheryl Scott began piecing together the inaugural issue of BioProcess International. In celebration of the 20th anniversary of this staple publication in the bioprocessing arena, we compared products and manufacturing capacity in 2002 with those in 2022 and delved into what has driven the changes that have occurred.…

30 Years in Microbial Manufacturing of Plasmid DNA, Vaccines, and Proteins

Richter-Helm BioLogics is a first-in-class biopharmaceutical CDMO with strong quality and customer focus. With 30 years of experience manufacturing microbially derived products — including product classes such as therapeutic proteins and peptides, antibody formats (e.g., VHH nanobodies), bacterial vaccines, and plasmid DNA (pDNA) — the company has gained first-hand knowledge that can be applied easily to individual customer projects. That positions it as a preferred and experienced partner, especially for plasmid DNA projects. Over the past few decades, Richter-Helm has…