John Donahue has over 30 years of experience in biopharmaceutical operations.  A chemical engineer by training, he spent 14 years at Immunex and Amgen in process development and cGMP manufacturing.  The second half of his career took him to multiple companies where he worked with and for multiple CMO’s overseeing process transfer, scale up, and cGMP production.  John has helped design multiple traditional and single use manufacturing facilities.

A recurring challenge John noticed across the industry is the existing approach to room-to-room liquid transfers.  From simple product transfers to staging buffers outside of cleanrooms, the limitations of existing pass-through methods consistently created problems.

Traditional solutions - typically a pipe through the wall with some type of end cap - force manufacturers to accept compromised cleanroom integrity, inefficient operations, complex tubing setups, and/or dependence on single-source vendors.

The FAST Box was invented to solve these issues.  It enables multiple tubing lines to run simultaneously, allows lines to be swapped independently while maintaining a seal, and supports the transfer of complete assemblies (filters, bags, and manifolds) intact — all without proprietary consumables.  As an added benefit, it also functions as a traditional material pass-through, eliminating the need for two separate systems.

Jeff Serle is a seasoned engineering professional with over 30 years of experience designing and delivering critical environments for biocontainment, chemical safety, and pharmaceutical manufacturing.  He specializes in developing high-performance, compliant facilities that meet rigorous safety, operational, and regulatory standards.

Jeff is also the Co-Founder of Flush Fasteners®, established in 2022, a company focused on innovative fastening solutions that support contamination control while enhancing the aesthetics and functionality of critical environments.

In addition to his technical expertise, Jeff brings a strong operational leadership background, driving the development and execution of advanced solutions for biocontainment and next-generation pharmaceutical manufacturing.

Visit Flush Fasteners for more information.

Jeff Gilmore has over 30 years of Owner/Operator and Contractor/Consultant experience in process engineering and large capital project delivery for the pharma/biotech industry.

Jeff holds a MS in Chemical Engineering from the Colorado School of Mines, is a licensed Professional Engineer, and has his Project Management Professional (PMP) certification from the Project Management Institute.

He is currently the CEO of cGMPnow which is solely focused on accelerating Next Generation Therapies to Patients by providing GxP Systems Engineering and GMP Compliance/Consulting services.

Visit cGMPnow for more information.