July-August 2022 Archives - BioProcess InternationalBioProcess International

20th Anniversary Issue: From the Editors

Founded in the middle of 2002, BPI published its first issue in January of 2003. Our 20th-anniversary issue thus takes the form of a state-of-the-early-21st-century industry report. Assembling this content has reinforced our appreciation of the remarkable paths that this industry has taken and continues to take — and our journey alongside it. Having worked as editors in this industry since August 1988 (Montgomery) and September 1996 (Scott), we’ve found it difficult to maintain a chronological grasp of developments —…

The Evolving Manufacturing Landscape: Reflections from PDA President and CEO

by Richard Johnson

The past 20 years have been a period of rapid change and development in the world and in the biopharmaceutical industry. One of the biggest changes has been the introduction of a pathway for biosimilars in the decade after 2010. Before that, no provision for “generic” versions of biologics existed. The European Medicines Agency (EMA) approved the first monoclonal antibody biosimilar in 2013, and the US Food and Drug Administration (FDA) followed with its first approval in 2015. Those approvals…

Transforming the Biopharmaceutical Development Roadmap

by Simon Kwong

Biopharmaceutical analytical methods have improved significantly since the early 1990s. Techniques and fundamental mechanisms largely have remained the same, but modern analytical tools are delivering better insights into drug-product characteristics thanks to improved reagent quality, method intensification, and automation. Harmonized regulations and the revolutionized role of contract development and manufacturing organizations (CDMOs) also continue to support bioprocess transformations. Improved Analytics and Standardized Single-Use Equipment Today’s analytical methods provide high resolutions and deliver reliable results quickly. For example, sodium dodecyl sulfate–polyacrylamide…

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

by Habib Horry, Piergiuseppe Nestola and Mandar Dixit

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

by Brian Mullan

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

by Christiane Bardroff

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

by Miriam Monge

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)

by John Boehm

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

by Eric Isberg

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

by Wolfgang Walcher

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…