Polymers provide a unique set of material properties, including toughness, chemical resistance, versatility, and low cost for both multiple-use and single-use bioprocessing systems. Polymer materials are manufactured as fittings and tubing for research and development (R&D) laboratories, as containers for bulk chemical and biological storage, as filters and separation technologies for downstream processing, and as containers and bottles for drug substance storage. These components and systems are helping drug companies improve their manufacturing flexibility, reduce their operating costs and capital…
2013
Advances in Sensor Technology Improve Biopharmaceutical Development
Today’s biomanufacturing operations require constant management of biopharmaceutical process attributes throughout process development and production. Continuous online measurements of pH, dissolved oxygen (DO), oxidation–reduction potential (ORP), and conductivity (Figure 1) allow real-time industrial process monitoring and adjustment. These functions are crucial to process improvement studies and accurate, reliable manufacturing of high-quality products. Figure 1: () “In the pharmaceutical industry, it is extremely valuable to see how an attribute changes with time and correlate that change with parts of the process,”…
Single-Use Technology and Modular Construction
To enable broad, global access to life-saving biopharmaceutical products, our industry is facing significant pressure to reduce the overall cost of manufacturing and enable local manufacturing where possible. Combined with growing markets outside the United States and Europe and development of high-titer, high-yield processes, that pressure has led to a shift in the industry’s approach to facility design and construction. Today’s biopharmaceutical production facilities must be flexible, cost effective, and readily constructed with minimal capital investment and construction timelines. As…
CMC Strategy Forum Europe 2013 6–8 May 2013 — Hilton Old Town (Prague, Czech Republic)
Organized by CASSS, an International Separation Science Society, the seventh annual CMC Strategy Forum Europe will focus on improving quality in development and manufacturing of biopharmaceutical products. Led by experts from global regulatory agencies, academia, and industry, this event series explores emerging aspects of chemistry, manufacturing, and controls (CMC) technology and regulation. The forums are designed to maximize dialog among participants. Relatively short and focused presentations set the agenda for panel discussions that engage all who have experience and expertise…
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…
Global Evolution of Biomanufacturing
Biomanufacturing of human therapeutics is beginning a global transformation. New technologies, improved processes, the emergence of biosimilars, and growing worldwide demand for vaccines and biologic drugs to serve local populations are driving this transformation. Over the next few years, diverse new markets will open, creating opportunities for a range of companies seeking to enter the field while putting pressure on established biomanufacturers to reassess their operating models. Many traditional barriers-to-entry in biomanufacturing are diminishing. Yet other challenges — including access…
2012 in Review
As children growing up, we could barely contain our anticipation for those banner, milestone years: entering first grade, becoming a teenager, turning 16 and then 18, high-school graduation. But even the most innocuous “in-between” years saw notable change and maturation, and 2012 was just such a year for the growing cell therapy sector. Although it is not likely to be noted as a pivotal or breakthrough year, 2012 nonetheless delivered some significant and welcome signposts of continued sector maturation. Here…
FDA Biopharmaceutical Product Approvals and Trends in 2012
The US Food and Drug Administration (FDA) granted 18 new biopharmaceutical product approvals in 2012, covering a broad range of innovation, novelty, and healthcare and market impact. The total includes 16 full/original approvals: biologics license applications (BLAs) and new drug applications (NDAs). The other two products received supplemental approvals, both of them influenza vaccines. Among the 18 approvals were eight recombinant proteins, including two monoclonal antibodies (MAbs) and one engineered antibody-like “trap” molecule. Table 1 lists them all. Table 1: FDA…