Friday, August 19, 2022 Daily Archives

Challenging the Norms of Facility Design and Innovation

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The past 20 years have spurred new technologies that enable flexible solutions to changing market demands. Small-scale tools, improved analytical methods, and innovative facility designs are among the notable breakthroughs. To enrich our understanding of the past 20 years of bioprocessing, BPI distributed questions to supplier companies. Below, Elyse Vlahos (director of process engineering at Genesis AEC) provides her perspective on innovation and future industry developments. Innovation and Regulations What have been the most important technical innovations over the past…

August 19, 2022

Turn-Key Biopharmaceutical Solutions for Next-Generation Facilities

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One of the most impactful innovations over the past 20 years of biopharmaceutical production has been the digital transformation of manufacturing processes. As executives of a solution provider for the pharmaceutical and biotechnology industries, we have witnessed the ongoing evolutions and applications of digital technologies. When digitalization is applied intelligently, time to market is shortened, and engineering, construction, commissioning, and qualification activities are accelerated. Digital platforms enable the aggregation of massive amounts of data derived from different sources such as…

August 19, 2022

Continuing Commitments to Quality Reflections on Contract Manufacturing Organizations and Success in the Biopharmaceutical Industry

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Nick Green has worked in the global pharmaceutical and healthcare-services industries for more than 35 years, including significant experience with third-party manufacturing of biological products. He currently serves as president and chief executive officer (CEO) of Avid Bioservices, a contract development and manufacturing organization (CDMO) that focuses on biopharmaceuticals derived from mammalian cell cultures. He has held senior leadership positions at several life-science companies. That includes time spent as president and CEO of Therapure Biopharma, Evolve Biologics, and Rhodia Pharma…

August 19, 2022

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

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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…

August 19, 2022

Surveying the Biosimilars Regulatory Landscape

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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…

August 19, 2022

Increasing the Efficacy and Impact of Cell and Gene Therapies

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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…

August 19, 2022

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

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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…

August 19, 2022

Transfection: Past, Present, and Future

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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…

August 19, 2022

A Biotech Revolution

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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…

August 19, 2022

Reflections on Career Opportunities in the Biopharmaceutical Industry

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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…

August 19, 2022