Business

Concerns, Collaboration, and Capacity

The BPI Theater is a 50-seat venue that for seven years has been located at the heart of the BioProcess Zone on the exhibition floor of the BIO International Convention. There, BPI provides attendees with four days of live presentations focusing on the latest scientific advances and business trends in biotherapeutic development and manufacturing. On Monday afternoon, 22 April 2013, Patricia Seymour of BioProcess Technology Consultants (BPTC) moderated a roundtable discussion on biosimilar development in the BPI Theater at BIO…

Biologics Have a Robust Pipeline

Earlier this year, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a report titled 2013 Report: Medicines in Development – Biologics. It lists 907 biologics currently in development at “America’s biopharmaceutical research companies.” The list includes biologics targeting more than 100 diseases that either are currently in human clinical trials or are under review by the US Food and Drug Administration (FDA). Of those 907 product candidates, the most common types are monoclonal antibodies (MAbs, 338), vaccines (250), and…

Broadening the Baseline

When the editors of BPI asked us at BPSA to put together a content-rich article on single-use issues, we were happy to do so. Our challenge was how to bring in multiple viewpoints about the growing business of single-use that would be a “quick read” for the BPI audience. The answer: an expert colloquy. Represented here are several of the most qualified industry spokespersons in single-use — all are members of BPSA and speak as directors of the alliance. Their…

Better Cells for Better Health

Since its inception 35 years ago, the biennial meeting of the European Society for Animal Cell Technology (ESACT) has built on a tradition of combining basic science and applications into industrial biotechnology to become the international reference event in its subject matter. Every other year, this gathering of academics and industry professionals features a famously exciting social program and an extensive vendor/supplier exhibition specific to animal cell technology. ESACT meetings are much-anticipated international venues for information exchange, inspiration, networking, and…

Supporting Continuous Processing with Advanced Single-Use Technologies

It has been 10 years since the US Food and Drug Administration (FDA) articulated — in its guidance for process analytical technology (PAT) — the goal of “facilitating continuous processing to improve efficiency and manage variability” (1). Since that time, regulators and industry have worked toward applying continuous processing (CP) to all facets of pharmaceutical manufacturing, including bioproduction (2, 3). Last year, the European Medicines Agency (EMA) referred to CP in its draft Guideline on Process Validation, and the FDA…

Women Helping Women in Biotechnology

How can we empower women to advance their own careers? How do we encourage entrepreneurship for more female scientists? What will get more girls excited about science? Those are questions that the Women In Bio (WIB) organization seeks to address as it creates programs and networking events across the country. WIB is an organization of biotechnology professionals whose mission is to promote careers, leadership, and entrepreneurship for women involved in life sciences. Started in 2002 as a small support network…

Seeding Tissue-Engineered Vascular Grafts in a Closed, Disposable Filter–Vacuum System

Tissue engineering is a multidisciplinary science that applies principles from engineering to the biological sciences to create replacement tissues from their cellular components (1). Resulting neotissues can repair or replace native tissues that are diseased, damaged, or congenitally absent. One technique that has come into widespread use is based on seeding cells onto a three-dimensional (3D) biodegradable scaffold that functions as a cell-delivery vehicle (2). Cells attach to the scaffold, which then provides space for neotissue formation and can serve…

The Role of Medical Affairs in Moving from R&D to Commercialization

Bringing a new pharmaceutical product to market is a unique process based on a number of requirements for supporting a product launch. For a research and development (R&D) company, launching a product into market may seem to be an issue for someone else to handle in the far-distant future and at a much later time. But even at laboratory or early development stages, biotechnology companies should understand the language of pharmaceutical companies and know how that industry operates. Doing so…

Broadening the Baseline

When the editors of BPI asked us at BPSA to put together a content-rich article for the single-use supplement, we were happy to do so. Our challenge was how to bring in multiple viewpoints about the growing business of single-use that would be a “quick read” for the BPI audience. The answer: an expert colloquy (a “conversational exchange or topical dialogue”). Represented here are several of the most qualified industry spokespersons in single-use — all are members of BPSA and…

Liquid or Powdered Media?

For decades, innovations in research and production techniques have been driving forces in the biopharmaceutical industry. But market conditions fueled by the economic downturn over the past five years have increased regulatory burdens in the United States and Europe. Rising costs and risks associated with new drug development now require that biopharmaceutical companies manufacture their products more quickly and cost-effectively than ever before. To this end, companies are looking for new ways to reduce expenditures, increase profitability, speed research, enhance…