Single Use Manufacturing & the Impact on Process, Facility Design & Procurement

Single use technology opens up a world of possibilities never considered before for biotech/pharma manufacturing but also brings with it a host of new challenges. As companies move from simple application of single use systems like bags (for buffer storage) to more complex single use systems and even entire single use facilities, the potential impact on product quality and manufacturing success grows. To address this, a number of groups including BPSA and BPOG have come out with guidance to assist both suppliers and end users in understanding and implementing best practices in areas such as extractables/leachables, supply chain management, and quality management. ISPE will be coming out with its own guidance to further supplement the work that has been done by these groups.

While I am personally very grateful to have more of these highly valuable documents at my fingertips than ever before, all the guidance documents in the world won’t help you if your project, company or team isn’t equipped to succeed in implementing these best practices. A couple of years ago, I worked on a team tasked with designing a facility to transfer an existing commercial biologic manufacturing process into. We explored single use technology in-depth – evaluating what technologies were available, the benefits and drawbacks of each, and where we were as a company in terms of what risks we were willing to take and the internal knowledge and experience we could leverage. In the end, we decided to take a hybrid approach, implementing single use where it provided the most “bang for the buck” and maintaining stainless steel equipment where we felt single use just wasn’t worth it for us.

On April 13, I’ll be presenting the process we went through to determine where and what single use to implement and how the decisions we made impacted our process, facility design and procurement strategies. I look forward to sharing this with the ISPE community and receiving feedback as we all work toward a common goal establishing and implementing single use best practices.