By Tom Piombino and Sue Behrens, IPS
Twenty years ago, just a few types of biologic drugs were being developed and ultimately commercialized, often using similar cell lines that required common equipment and facility designs. That is definitely not the case today. Early clinical successes with next-generation therapies based on cells, genes and viral vectors are driving investment in manufacturing facilities for these and other personalized medicine products, which require novel technologies and engineering designs. Many second- and third-generation antibody-based drugs also require different manufacturing processes.
In addition, the pharmaceutical market has become very diverse and is no longer focused solely on blockbusters; smaller-volume products that treat targeted patient populations account for a growing percentage of portfolios and pipelines. The high potency of some biologics also contributes to a need for smaller product volumes. There is also increasing investment in vaccine manufacturing.
As a result, many biopharmaceutical manufacturing plants today produce multiple products with varying properties that require different production processes. Engineering and design firms with the right skill sets can take on an educational role, helping these companies understand the timing of investments and skills they need to develop in order to become manufacturing organizations.