By Tony Khoury, Vice President; Phillip Massey, Associate Director; Anthony Prince, Consultant
Content featured by Project Farma
Technological advancements in the biopharmaceutical industry over the last decade have led to medical breakthroughs being approved at an exponential rate. Previously untreatable diseases are now being cured, giving hope to patients and families worldwide. Now more than ever, speed to market and quality is critical in clinical and commercial manufacturing.
With such rapid market growth, demand has increased for flexible alternatives to centralized manufacturing. Having a full-scale GMP facility for each new therapy is implausible yet most facilities are not equipped with the flexibility required to manufacture multiple products. Drug developers and the Contract and Development Manufacturing Organizations (CDMOs) have experienced a significant bottleneck to getting therapies through the clinical and commercial process and ultimately to patients.
In addition, manufacturing technologies continue to evolve, especially for cell and gene therapies, and therefore require innovative manufacturing methods. These factors combined with an urgency to bring the drugs to market as soon as possible, has put pressure on companies and industry experts to find innovative ways to produce drugs.
We have seen our customers employ various approaches to solving these challenges. One approach that we have had first-hand experience with and that has worked well in a number of projects is the use of G-CON’s POD technology. Companies like G-CON are now offering flexible, pre-fabricated modular cleanrooms that are built offsite and delivered as a product to the customer site. Project Farma worked with these cleanrooms from their early designs and shared customer feedback as an input to its most recent, complete solution. These prefabricated modular cleanrooms offer several key advantages that are well-known to the industry:
- Flexibility in the process and production
- The ability to scale without interruption
- Reduced product timelines and cost
- Portable platform for easy placement and rapid deployment
- Seamless integration into “gray space” or non-controlled area