Author Archives: Cheryl Scott

Sharing Viral Vector Expertise: A Conversation with Yposkesi’s Chief Executive Officer

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…

eBook: Next-Generation Vaccines — COVID-19 Challenges, Opportunities, and Patent Questions

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…

eBook: Development of Bioassays — A Report from the BEBPA’s First Virtual Meeting

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…

Discussions at Phacilitate 2020 on Business, Manufacturing, and Future Trends

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…

April 2020: From the Editor

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.…

eBook: Microbial Expression — The Right Choice for Large Peptides and Small Proteins

Although animal cell culture has dominated the biopharmaceutical industry for some years now, microbial expression remains important for producing proteins that don’t require posttranslational modifications — or only those that prokaryotic microbes can perform. It also offers an affordable option for antibody fragments and gene therapies. Microbes may be less fragile than animal cells, and they do require simpler media, but they present other challenges related to temperature management and oxygen transfer in culture. Wherever practical, bacterial expression is preferred…

eBook: Peptide Therapies — Small Biomolecules Address Big Health Problems

This crash course in the development of peptide therapies brings together two articles: one on product research and the other on manufacturing and regulatory concerns. In “Fighting Alzheimer’s Disease from Within: A Breakthrough Peptide,” freelance journalist Marc Davis highlights current developments in Alzheimer’s disease treatment, focusing specifically on a peptide approach from Canadian company NervGen. In “Making Peptides Work,” BPI’s senior technical editor adds perspective on developing and manufacturing peptide therapies from the Informa Connect community, with commentary from experts…

From the Editor: January–February 2020

I’ve been enjoying the inevitable social-media debate over whether we’re starting a new decade now or next year. Editors adore that sort of thing — but as much as I love accuracy, I must admit that I’m in the “now” camp. Welcome to the ’20s, anyway, whether or not you think that’s equivalent to “the second decade of the new millennium.” We humans love patterns and milestones, so watching the odometer tick over always brings about a sense of nostalgia…

Bioassay Evolution: Finding Best Practices for Biopharmaceutical Quality Systems

Bioassays help drug developers determine the biological activity (potency) of their products, which has been a biopharmaceutical critical quality attribute (CQA) since long before that concept had a name. Because of their complex nature, bioassays are among of the most challenging experiments to perform reliably with dependably accurate results. Consistent assay performance requires a controlled environment and qualified reagents; skilled analysts who understand cell physiology, regulatory requirements, and the latest techniques; and assay protocols that are intelligently developed, characterized, and…

Challenges and Opportunities in CAR T-Cell Development and Manufacturing

Just about anyone in the biopharmaceutical industry will tell you that cost is now the primary concern in cell and gene therapy development. It hasn’t even been a decade since “manufacturability” was the main issue at hand — and cost has risen organically from related discussions. Regenerative medicine evolved from medical research rather than from drug-development companies, and technologies that worked in clinical settings haven’t translated directly to manufacturing facilities. Cost is often the problem. Early product successes (that ultimately…