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

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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…

August 22, 2022

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

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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.…

August 22, 2022

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

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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…

August 22, 2022

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

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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…

August 22, 2022

Advanced Materials in Bioprocessing

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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…

August 22, 2022

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

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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…

August 22, 2022

Advances in Cell-Line Development, Banking, and Authentication

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Living cells are foundational technologies in the biopharmaceutical industry. They serve as hosts for production of therapeutic proteins, models by which to test clinical candidate efficacy and potency, tools for developing and validating bioanalytical methods, and even as medicines. To enrich our understanding of the past 20 years of bioprocessing, BPI distributed questions to supplier companies, including those that have spurred on innovation in the manufacture of critical starting materials. Below, representatives from ATCC reflect on advances in developing, banking,…

August 22, 2022

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

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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…

August 22, 2022

Innovations in Cell Culture, Sensor Technology, and Process Control: Preparing for Industry 4.0

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To celebrate the 20th anniversary of BioProcess International, industry suppliers were asked to respond to a questionnaire about the important technologies, trends, and manufacturing innovations that have shaaped their companies and the entire industry over the past two decades. What has been the most important scientific or technological innovation in the past 20 years of bioprocessing? I have been in the industry since the mid-1990s, and clearly the most significant evolution in biomanufacturing has been the widespread implementation of single-use…

August 22, 2022

Bioprocess Monitoring and Control: New and Continuing Needs in the Biopharmaceutical Industry

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Equipment vendors, technology developers, and service providers have played an integral role in promoting innovation in the biopharmaceutical industry, from upstream production to final packaging and distribution of biological products. To enrich our understanding of the past 20 years of bioprocessing, BPI distributed questions to supplier companies. Below, Nick Pittman and Magnus Wetterhall of Waters Corporation reflect on advances in — and remaining opportunities for — process analytical technologies (PATs). What Innovations Have Been Most Formative to the Past 20…

August 22, 2022