Traditionally, the CaSSS CMC Strategy Forum meetings have provided a scientific focus on the development of biotech drug substances and their manufacture and characterization, leaving the development of drug product formulation and filling, understanding primary containers, and considering novel delivery systems somewhat out of scope. Over recent years, however, the importance of investing more science and technology into drug product development has become evident as different product types, higher protein concentrations, and doses and requirements for improved delivery of biological…
Business
The Influence of Polymer Processing on Extractables and Leachables
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…
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…
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…
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…
A Powerful Pairing
Biological product and process characterization are not new to this quality by design (QbD) and process analytical technology (PAT) era. In the 1990s we saw the FDA introduce the concept of well-characterized biologics: an acknowledgment that analytical technology had advanced to the point where the bioprocess did not necessarily (or not fully, anyway) define a biopharmaceutical product. That ultimately led to the regulation of some types of products within the United States moving from the purview of FDA’s Center for…
Automation of Cell Therapy Biomanufacturing
Biomanufacturing automation is an established mission-critical step in the commercialization pathway for conventional therapeutics, including small molecules and monoclonal antibodies (MAbs) (1). The prospect of a potential biologic progressing into late-stage clinical trials without a robust biomanufacturing strategy to support at least pilot-plant scale bioprocessing is simply unthinkable. Conversely, the cell therapy industry (or at least a significant proportion of it) regard this as a trend that is unlikely to be mirrored as the industry develops. The aim of this…