GMP fermentation today is a complex process that requires a large investment in expertise, equipment, process, and quality control, and very few companies in the industry currently have or choose to invest in developing those resources in-house. A deep understanding of quality systems, strain development, process development, scale-up, isolation, and purification can help ensure pharmaceutical firms make the right decisions in large-scale fermentation outsourcing and help companies make the right choices for their supply-chain requirements.
Make or buy?The fermentation of microorganisms is the basis for the production of a wide range of products such as antibiotics, hormones, and specialized proteins, thereby making fermentation an important process for related commercial products. Fermentation is frequently the preferred production method, particularly with therapeutic proteins or chemical compounds requiring a multistep synthetic process offering the optimal economic route and allowing firms to shorten their production process and time to market. Because of the importance of fermentation in the industry, it figures prominently in a company's overall decision regarding which processes and functions it must outsource.
Fortunately, selecting an outside provider offloads a number of procedures and controls related to the fermentation process, including raw material qualification, master and batch production records, change control procedures, deviation investigations, fermentation sterilization validation, downstream process validation, cleaning validation, equipment qualification, expiration testing, and stability testing.
Perhaps the biggest factor that drives pharmaceutical manufacturers toward the "buy" decision for fermentation is cost. The capital investment for a properly equipped current good manufacturing practices (CGMP) fermentation facility, including manufacturing equipment and utilities, is significant and often runs into the high tens of millions of dollars. In addition, the provision and training of a technical staff (manufacturing, technical support, quality assurance and quality control, engineering, maintenance and utilities, etc.) further adds to the investment required. By outsourcing to a company that already has the staff and facilities in place, customers can significantly accelerate their timeline and minimize overall investment. Quite often, outsourcing to a specialized provider of custom fermentation services is the lower cost option, a key driver in swaying executive management in a time of tight cost controls.
Once the outsourcing path is chosen, the supplier selection process requires a series of key considerations for making the right contracting decisions regarding large-scale fermentation.