New Regulations Influence Design of Bio/Pharmaceutical Manufacturing Facilities (INTERPHEX 2024)

Editor's note: this interview was originally published on PharmTech.com.

Nadiyra Walker Speight, senior director, Drug Product & Finished Goods, at Fujifilm Diosynth Biotechnologies, and Christa Myers, senior fellow and vertical market leader, Aseptic and Sterile Products at CRB Group, both sat with BioPharm International® during INTERPHEX 2024 to discuss how new regulations, particularly those specified in Annex 1, are impacting the way bio/pharma manufacturers must think about manufacturing facility design.

When it comes to manufacturing facility requirements, regulations and expectations never get less stringent, said Speight, who noted that the industry should always be aiming to exceed compliance expectations knowing that it is a moving target.

Speight and Myers both agreed that new regulations, especially those spelled out within the European Union's Annex 1 guidance, can pose a significant challenge for bio/pharmaceutical manufacturers.

"Cost is ever-present. These facilities get bigger and bigger and bigger. We're starting to understand capacities for patients and companies so we can right-size facilities and get down to right costs for these facilities," Myers commented, agreeing with Speight that having an operations professional closely involved in facility design can help navigate difficult decisions that pin construction cost and time against efficiency in facility operations.

In the interview, Myers and Speight further address the effects that the Annex 1 guidance are having on facility design and the importance of ongoing, quality-focused training for operations-level professionals to ensure the delivery of an optimal product.

INTERPHEX 2024 was held in New York City on April 16–18, 2024.