Contamination Event Free Production Process by 2022
For three years the microbial team has worked to address significant challenges in the areas of quality, risk, and cost – all with positive results. But satisfying operational issues was only delivering success on one level. Through recognizing the strategic needs of the member companies, a more significant objective emerged: achieving an industry-wide contamination free production process.
Informed by the members’ strategic goals and the Technology Roadmap plan, the team was able to describe a compelling purpose and a realistic plan to ultimately eliminate microbial contamination issues in the production process within five years.
A meeting held recently provided the opportunity to refine and agree the way forward:
“This meeting converges the vision and action for the optimal microbial control strategy for those who are concerned with and involved in managing microbial contamination risks in biopharmaceutical manufacturing,” said Ren-Yo Forng, Amgen.
To develop best practices, provide guidance and drive consistent application of effective and efficient microbial control strategies for manufacturers of low bioburden bulk biologics in order within five years to:
>bring all sites to the contamination prevention performance level of the best
>support the Technology Roadmap ambition for new product launches
>demonstrate complete mastery of Microbial Control and gain regulatory support for Microbial Control strategy.
While ambitious, the vision and plan can be achieved by collaborating with members to leverage the operational, technical and cultural elements that exist in pockets across the industry. This plays to the strength of the BPOG collaboration – when members come together to share their individual practices and create a whole that is greater than the sum of the parts.
Creating and delivering a compelling strategy and implementation plan for microbial control will address critical operational issues such as the reliability of automated laboratory equipment, enable the successful delivery of the Technology and achieve complete mastery of microbial control.