The portfolio sold by today’s global biopharmaceutical industry is fundamentally different than it was even a decade ago. This shift is a reflection of today’s global market, which features greater competition, more treatments for orphan diseases, an increase in large-molecule drugs, and personalized or targeted medicines. The result has been genotype-specific biopharmaceutical products produced in extremely limited production runs under tightly controlled manufacturing specifications.
As the industry evolves in its quest to increase quality, productivity, efficiency, and safety, engineers must be equipped with skills that enable them to meet new and challenging demands. This first in a two-part series focused on biopharmaceutical manufacturing explores a few of the exciting roles engineers play to drive continuous improvement. Part 2, slated for Pharmaceutical Engineering’s November-December 2017 issue, will focus on how engineers working in the traditional pharma industry can leverage their background and gain new skills to transition into the biopharma sector
China and India have demonstrated their capability in good manufacturing practice (GMP) manufacture of small molecule drugs for decades. But production of biological therapeutics has, until recently, not been done to GMP standards due to the greater complexity of bioproduction and the need for highly trained staff, regulatory expertise, and quality management systems.
Innovations in biopharmaceutical and sterile pharmaceutical equipment design and operation are proving their potential to reduce contamination during routine manufacturing. Based on the concept of “closed systems,” these improvements isolate the process from both the surrounding environment and operators. They also lessen the importance of facility design as a source of contamination and enable more efficient site layouts with reduced environmental control requirements.
This special section looks at what’s coming up at the 2019 ISPE Annual Meeting. It also features the voices of first-year Travel Grant recipients who attended last year’s Annual Meeting courtesy of the ISPE Foundation and offers a look at the 2019 Facility of the Year Award (FOYA) category winners...
Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program. This year’s nine category winners and honorable mentions range from industry giants with hundreds of years of history to relatively new enterprises....
The ISPE Foundation® awarded 14 Student Travel Grants to bring 14 students to the 2018 ISPE Annual Meeting & Expo. Investing in the next generation of pharmaceutical engineers is a goal of the Foundation, which was formed in 2018.