2022 Archives - Page 10 of 19 - BioProcess InternationalBioProcess International

20 Years of Chemistry, Manufacturing, and Controls Strategy. A Conversation About the CASSS CMC Forum Series

by Cheryl Scott, Nadine M. Ritter and Mark Schenerman

Formerly known as the California Separation Science Society, the CASSS organization has maintained a close relationship with BioProcess International since its inaugural year. In particular, the CMC Strategy Forum series began the same year that BPI’s original staff joined Informa to develop a new international trade publication covering biopharmaceutical development and manufacturing. Beginning with our February 2004 issue, BPI has been proud to publish dozens of reports from this influential series of meetings over the years. Their success around the…

Surveying the Biosimilars Regulatory Landscape

by Brian Gazaille and Tina Morris

BPI’s history coincides with that of biosimilars development. Although nonpeptide biosimilar products did not begin receiving commercial authorization until the 2010s, health authorities and drug makers already had been exploring the complex concept of biosimilarity. In the May issue of BPI’s first volume, Theresa L. Gerrard (then an independent consultant who also had been director of the Division of Cytokine Biology at the US Food and Drug Administration Center for Biologics Evaluation and Research, FDA CBER) wrote: The potential for…

Increasing the Efficacy and Impact of Cell and Gene Therapies

by Susan Nichols

Decades of research into cell biology, gene editing, and biomanufacturing have culminated in the commercialization of more than a score of cell and gene therapy (CGT) products. In the United States, most of those are hematopoietic progenitor cells (HPCs) isolated from human umbilical cord blood. As of July 2022, the US Food and Drug Administration has approved five products based on chimeric antigen receptor (CAR) T cells, all since 2017, and two viral-vector gene therapies, beginning with the 2019 authorization…

Taking a Distinctive Path Reflections on the History of Gene Therapy Development

by David Backer

For the past 20 years, I’ve been a committed and interested partner to developers of cell and gene therapies (CGTs). I’ve participated in the highs and lows of the industry. Initially, we looked to the development of monoclonal antibody (MAb) therapeutics for a roadmap to anticipate what would occur in the CGT field. It was thought that manufacturing processes would consolidate upon a single “winning” platform process and that both scale and productivity would be increased primarily by focusing on…

Transfection: Past, Present, and Future

by Miguel Dominguez

The science behind transfection spans from calcium phosphate precipitation to newer methods that are easier to perform, more efficient, and consistent. Mirus Bio strives to perfect gene delivery to cells in culture and support different applications within the life sciences community. The company’s capabilities include RNA interference (RNAi), clustered regularly interspaced short palindromic repeats (CRISPR), and viral vector development for cell and gene therapies with the launch of TransIT-VirusGEN GMP transfection reagent and kits for supporting clinical and commercial adenoassociated…

A Biotech Revolution

by Tony Hitchcock

To celebrate the 20th anniversary of BioProcess International, Tony Hitchcock (technical director at Charles River Laboratories) participated in a supplier survey on important bioprocess innovations, technologies, and advancements over the past two decades. He has over 38 years of experience in the biotechnology industry, specifically in production of critical starting materials and complex biologics for clinical trials. What is the most important bioprocessing innovation in the past 20 years? The emergence and adoption of single-use production systems has been important…

Reflections on Career Opportunities in the Biopharmaceutical Industry

by William G. Whitford and Anna Lindberg

Mindset is important to working in the biopharmaceutical industry. Three distinguishing behaviors will enable new entrants to build rich and fulfilling careers: keeping an open mind, serving a purpose for the benefit of a greater good, and making risk-based decisions. The range of experiences in our own careers can help to illustrate the broad array of opportunities that you can find in the life sciences when such a mindset is applied. Below, we discuss some of those experiences and lessons…

Evolution and Uptake of Bioprocess Economic Modelling

by Andrew Sinclair, David Pollard, Yuki Abe and Rob Noel

The commercial successes of the biopharmaceutical industry over the past 20 years are a reflection of a maturing industry whose increasing focus on efficiency and cost effectiveness will expand the adoption of digital technologies into knowledge management, process/cost optimization, and manufacturing. The ultimate goal continues to be reducing costs to manufacture effective medicines efficiently and broaden patient access to life-saving drugs. Here, we review the journey of bioprocess cost models and how they have helped the industry build process knowledge…

From PDFs to Digital Submissions The Rapid Pace of Regulatory Change

by Karl-Heinz Loebel

The pace of regulatory change in the pharmaceutical industry over the past 20 years has been rapid. Although heightened emphasis on patient safety, data transparency, and harmonization has prompted new guidance’s and requirements, perhaps what is most notable is the rate at which technology has changed how processes are documented and regulated. Today, digitization is entrenched in day-to-day life and is steadily becoming the norm among health authorities and at pharmaceutical companies. But just two decades ago, incorporating technology-led regulatory…

The Changing CDMO Landscape

by Dan Stanton

Contract development and manufacturing organizations (CDMOs) have evolved from simple service providers to full partners. Such companies now offer development and end-to-end services for highly complex biologics in a transition from contract manufacturing organizations (CMOs) and contract research organizations (CROs) to CDMOs. Before 2000, some drug companies (e.g., Merck, Novarits, Boehringer Ingelheim, and others) offered their excess manufacturing capacity to other drug makers. Chemical companies provided fill–finish and related services. Between 2000 and 2008, a number of dedicated CMOs emerged:…