How ATMPs Have Changed The Fill-Finish Industry Forever

By Laura Moody, Ph.D., North American product manager, Syntegon Pharma Technology

It is apparent that the pharmaceutical industry is investing in and driving the development of advanced therapy medicinal products (ATMPs), as evidenced by the growing cell and gene therapies in pipelines around the world. The rise of ATMPs have proven to drug manufacturers that the industry is getting more specialized, with a shift towards smaller batch sizes. Traditional high speed, high output fill-finish machines do not fit the needs of these no-longer-niche applications. The high value of ATMPs results in less tolerance for wasted product. Even the smallest volumes have the potential to save lives. Therefore, ensuring each container has the precise amount of drug product is essential. The focus for manufacturers is now high precision of high-value products with lower outputs as the leading factor for fill-finish processing. These refocused priorities require adaptations in  the packaging industry to accommodate changing pharmaceutical manufacturing requirements.

Flexibility in pharmaceutical production is another increasing prerequisite in the industry. As batch sizes shrink, manufacturers need to fill multiple products on the same equipment, often times in varying container types (i.e. vials, syringes and cartridges) and container sizes, as well as varying sources such as non-sterile bulk, trayed or nested pre-sterilized ready-to-use containers. To this end, single-use technology has seen an explosion in adoption at all stages of pharmaceutical production. Without the need for manufacturing parts dedicated for individual drugs in a facility, expensive cleaning validations of said parts, and lengthy changeover times, production times and costs shrink, and up-time efficiencies grow. Having the ability to process a large variety of drug products and containers on the same, multi-use filling line gives pharmaceutical manufacturers the ability to save manufacturing space and be nimble for future opportunities.

Downstream manufacturing suppliers need to adapt to the requirements of this evolving market, where flexibility is a necessity. This article highlights the changing requirements for downstream processing of small batch drugs, along with how machine manufactures are adapting to the evolving needs of the industry.