Technology is not new. Biotechnology is not new; it’s new-ish. Yet when the two come together to look at how they can transform medicine, its creation, delivery, and access, well, that is new and can be extraordinary. Extraordinary enough that the FDA established the Emerging Technology Team (ETT) in the Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) in 2015.
Sau Lee, PhD, who chairs the team, explains the ETT’s intentions and outlook in our cover story, “Just Getting Started: 3D Printing and Bioprinting in Pharmaceutical Manufacturing.” In that story, author Scott Fotheringham, PhD, looks at 3D printing and bioprinting. He pursues still other technological advances in his feature “A Good Fit: The Marriage of Pharma and Tech Yields Benefits for Patients,” discussing several pharma/tech alliances and their ambitions.
Our chapter profile highlights ambition, too. Mike McGrath spoke with the Great Lakes Chapter President Deborah Geyman about its recent financial struggles and how she sees brighter days ahead—did you know Great Lakes serves more than 800 members scattered across the six states surrounding Lake Erie and Lake Michigan? On this same topic of ambition, tenacity, and diligence, Mary Foss offers thoughtful advice to students entering the industry for the first time, and our regular columnist David Smith reveals the best way to “ace” a telephone interview.
Our technical authors look at patient safety from novel angles: applying QRM to reduce HVAC costs (Appleby, et al.), the benefits of ozone technology in water pharmaceutical systems (Cohen and Johnson), how to minimize and control microbiological contamination in water systems (Sandle), the reliability of sterility assurance tests (Stering), and a method for demonstrating content uniformity (Stepanic and Saeed).
All in all, we have a little bit of something for everyone in this issue, and I hope you enjoy it. To view these articles and more, check out the July – August 2017 issue of Pharmaceutical Engineering® magazine.
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Like any investment in digital manufacturing systems, demonstrating business payback before and after investment is critical to getting MES projects approved and verifying profitability after investment. Whether it is introducing MES, expanding it to additional sites, switching software, upgrading existing software, or developing electronic production records (EPR) for new drug products,...
Sustainability is emerging as a pivotal force influencing the pharmaceutical industry’s dynamics and steering companies towards transformative change. The focus of this analysis is to delve into the sustainability key performance indicators (KPIs) of prominent pharmaceutical players, namely Pfizer, Sanofi, Glaxo Smith Kline (GSK), Becton Dickinson, Johnson & Johnson, Abbott, Eli Lilly, and...