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.
