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…
Business
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…
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…
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…
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…
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…
The Biotech Boom Down Under
Australia is a key global player in biotechnology investment for the Asia-Pacific region. The environment is characterized by outstanding research facilities, accelerating employment in the industry, uniquely Australian discoveries, and burgeoning alliances between Australian and international companies. Australia’s biotech companies are rapidly maturing. The country has 427 core biotech companies that are active in human therapeutics (48% of companies), agricultural biotech (16%), and diagnostics (14%) (1). Partnerships between multinationals and Australian companies and research organizations indicate growing international appreciation of…
Integrating Modular Design–Build Execution Strategies into Biotech Projects
One of the earliest and most important decisions in a biopharmaceutical facility construction project is choosing a project execution strategy. This choice affects cost, schedule, and quality of the immediate project as well as further operations throughout the facility life-cycle. As technology and best practices evolve in the early 21st century, many biopharmaceutical facility projects are integrating some form of modularization execution strategy to maximize predictable costs, schedules, and quality benefits. The modularization concept can manifest as prefabricated buildings, modular…