Many models are available for establishing a quality system in regulated industry, whether for pharmaceuticals, medical devices, or biologics. Each company establishes a set of standard operating procedures (SOPs) that enables it to manage operations and then implements a quality system around its product and process. But why do some quality systems work well, whereas others falter or fail miserably? Does the fault lie in procedures, implementation, or maybe training? Perhaps the answer can be found by examining the involvement…
Business
Throwing a Flag at Biosimilars
PHOTO COURTESY OF ROGER LUNDBLAD (PICTURED). When I officiated at high school (US) football, I learned a lot from the experience. Contrary to popular opinion, there are rule books referees study. However, although the rule book is modest in size, the case book for interpretations is large. This brings me to the topic of generic or follow-on biologicals and biosimilar products for which there will be rules, and the interpretations will be many. Continuing with the US football analogy, the…
Cell Cultivation Process Transfer and Scale-Up
The introduction of therapeutic monoclonal antibodies (MAbs) has greatly revolutionized therapies for several cancer immune disorders (1,2,3,4,5). Benefits to patients have been substantial, translating into both increased life expectancy and improved quality of life. Currently, twenty-one therapeutic MAbs are registered for marketing in the United States, with the introduction of several more expected in the coming years (6,7,8,9,10,11). PRODUCT FOCUS: MONOCLONAL ANTIBODIESPROCESS FOCUS: Technology transfer (production) and analytical methods developmentWHO SHOULD READ: PRODUCTION AND PROCESS DEVELOPMENT, MANUFACTURINGKEYWORDS: IGF-1R, EXPRESSION, TECH…
Shared Risk
Risk is inversely proportional to one’s distance from a problem. For regulators, it seems straightforward to control biopharmaceutical and medical device risk. For pharmaceutical, biotechnology, and medical device executives, however, risk is hardly so clearly defined; it extends, grows, twists, and compounds through a chain of suppliers, consultants, and business partners. So when regulatory officials claim that compliance accountability cannot be delegated, biopharmaceutical and medical device companies are left holding the bag. Years ago, as a C-level executive for a…
IP Strategies to Combat Distribution of Counterfeit Drugs
Counterfeit products are no longer restricted to Gucci purses and Rolex watches. The pharmaceutical business has seen an alarming rise in the number of counterfeit products entering traditional distribution and supply chains. As a result, consumers can unknowingly purchase counterfeit pharmaceuticals from their local pharmacy and receive little or no therapeutic benefit, or worse, die as a result of ingesting counterfeit products. Pharmaceuticals are subject to counterfeiting in a number of ways. A counterfeit product may contain no active ingredient…
The Biopharmaceutical Industry’s New Operating Paradigm
Currently the biopharmaceutical industry is transitioning to a new business model of production efficiency through implementing operational excellence (Op Ex). Borrowing from such principles as “lean manufacturing” and “Six Sigma” (6σ), and incorporating quality by design (QbD) (1), Op Ex is being applied through the implementation of such advanced enabling concepts and technologies as quality risk management (QRM) (2), process analytical technology (PAT) (3), and systems biology (SB) (4). Some people see a conflict here: This paradigm shift is occurring…
Is the FDA Trailing on the Biopharmaceutical Drive?
In the heady days of the biotech boom of the early 1990s, the ground shook as salvo after salvo of innovative regulatory guidance documents emerged from the US Food and Drug Administration (FDA). Even their titles were innovative: “Points to Consider in the Production…” rather than the stodgy “Code of Federal Regulations, Volume X, Part XX.” The FDA was supporting the development of the emerging biopharmaceutical industry through rapid uptake of technological and clinical developments and speedy conversion into guidance…
Demonstrating Comparability for Well-Characterized Biotechnology Products
Challenges and approaches in demonstrating comparability of a well-characterized biotechnology product after manufacturing changes can be as varied and complex as the products themselves. Participants at the January 2005 CMC Strategy Forum sought to discuss and agree on common implementation strategies for different manufacturing change scenarios. Development of flexible, comprehensive approaches in strategy development addressed evaluation of critical product characteristics, appropriate process steps to test, numbers of lots and levels of testing required, and assessment of product comparability (e.g., trending…
Accelerating Commercialization
In summer 2007 the MaRS (Medical and Related Sciences) center in downtown Toronto broke ground for a massive expansion. The fact that this innovative science and technology commercialization facility is more than doubling in size — to 1.6 million ft2 — less than two years after its official opening, indicates the healthy state of life sciences in Ontario. MaRS is a state-of-the-art convergence center where leading venture capitalists, pharmaceutical companies, research funding agencies, and cutting-edge businesses come together under one…
Construction and Start-Up Costs for Biomanufacturing Plants
All bioproducts heading to commercialization go through a rigorous process that includes research and development, proof of concept, and validation studies. Furthermore, the fabrication process of a biological product is very different from that of a classical (synthetic small-molecule) pharmaceutical. That’s not only because of specific characteristics and requirements of the molecular entities involved, but also environmental considerations and specific issues related to human health and safety. Such differences are reflected in the cost drivers of approved manufacturing plants. Herein…