An old engineering adage says that in any technical project, you can get speed and/or quality and/or cost-efficiency — but you never get to have all three. The idea is that emphasizing any one of those parameters necessarily deemphasizes one or both of the others. For most of the biopharmaceutical industry’s early years, companies operated on that assumption. Many organizations saw speed as the weakest link that could be more or less ignored; others had money to burn. The smartest…
With 20 years of experience in the biopharmaceutical industry — at Genentech, Applied Biosystems, Cell Genesys, Cellerant Therapeutics, and Bayer — Yuval Shimoni has written frequently for BioProcess International on a number of production topics. Those have ranged from process improvements and bioreactor scale-down validation, to raw materials management, to addressing variability and virus contamination events. For this featured report, we discussed hardware and instrumentation, quality by design (QbD) and related approaches, and other strategies that can take expediting upstream…
After over a quarter century in the industry — including downstream processing (DSP) and manufacturing directorships at Boehringer Ingelheim and leadership roles in technology development, quality, and manufacturing at Novasep — European consultant Margit Holzer is a recognized expert in downstream processing of biopharmaceutical products. Holding a doctorate in biotechnology from the University of Natural Resources and Applied Life Sciences in Austria, Holzer is familiar to BPI readers as both an author and conference participant (1, 2). And in May…
As head of bioanalytics at Sanofi, Claire Davies leads a team of >90 people involved in development, qualification, and transfer of methods to internal and external commercial quality control units; characterization, comparability, and developability of proteins and gene therapies; and analytical support for up- and downstream development, production, product release, and stability testing. She has served in a number of roles over 18 years with Sanofi, from chemistry, manufacturing, and controls (CMC) leadership of preclinical to commercial products (leading and…
As founder of cell and gene therapy (CGT) specialist firm Dark Horse Consulting Group in California, Anthony Davies speaks from a quarter century of experience including former positions at Onyx Pharmaceuticals, Syrrx, ZymeQuest, Serologicals, Geron Corporation, Capricor, and 4D Molecular Therapeutics — and he currently serves on the board of directors for TrakCel and the scientific advisory boards for Akron Biotech and BioLife Solutions. In his plenary address at the Phacilitate 2020 Leaders World conference (part of Advanced Therapies Week…
As a full-service contract development and manufacturing organization (CDMO) specializing in gene therapy development, Yposkesi produces recombinant adenoassociated virus (AAV) and lentivirus (LV) vectors using adherent-based and suspension-adapted cell expression platforms. Alain Lamproye joined the company as chief executive officer (CEO) in January 2017, having served previously as president of the biopharmaceutical business unit of Novasep (2012–2017) and as CEO of Henogen, its subsidiary dedicated to gene therapy. He has held managerial positions in pharmaceutical operations at Merck Serono (including…
Resolving the COVID-19 pandemic depends on treatments, testing, and ultimately a widely disseminated vaccine against SARS-CoV-2. In recent decades, the biopharmaceutical industry has developed new approaches to vaccination using antigens, virus-like particles (VLPs), viral and bacterial vectors, and nucleic acids. Current events have placed those innovations at the front and center of public attention, offering many companies an opportunity to demonstrate their potential in an unprecedented way. Here, BPI’s senior technical editor describes the challenges that developers face in doing…
Bioassay development is one of the most challenging aspects of biotherapeutic development. These tests are vital to providing an accurate picture of potency, stability, and biological activity. But bioassay development can be complex and expensive — and often test results can vary. Cell-based bioassays especially lack robustness. In March 2020, the Biopharmaceutical Emerging Best Practices Association (BEBPA) presented its annual bioassay conference in virtual format. Here, BPI’s senior technical editor reports on the conference’s discussions. Read on to learn more…
Presenters in the three main program tracks at the Phacilitate Leaders World conference in Miami, FL, this past January represented sponsor-developers of cell/gene-therapy (CGT) products, contract service providers, and technology suppliers to the industry. Topics include process and product development strategies for advanced therapies, regulatory and inspector expectations, automation and closed-system processing, the choice between in-house and outsourced manufacturing, quality assurance and control, analytical methods, viral vectors, and artificial intelligence and Industry 4.0. At the end of each session, presenters…
As I write, the world is in a state of medical and economic uncertainty related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the coronavirus disease (Covid-19) that it causes. Our company group, Informa Connect, has been forced to reschedule some major conferences — including BPI West and BPI Europe — but it’s not alone. Many life-science meetings have been canceled or postponed, and some Biogen employees probably wish their management meeting late in February had been as well.…