Joseph Phillips, Ph.D., Senior Vice President & Head of Pharmaceutical Development at ArmaGen, Inc
The rate of discovery of new biologic modalities and the pace of innovation for viral vectors, cell and gene therapies, and the need to focus on defined patient populations to address specific therapeutic demands are leading to more production of smaller batches of drugs. This increases the need for more efficient process platforms that facilitate multi-product production, faster batch turnaround, and manufacturing flexibility. It also requires specialized expertise and knowledge of new and evolving biotherapeutic manufacturing technologies to successfully execute these processes.
Small and emerging companies pursuing new therapeutic indications often struggle with the wide range of drug development financial demands while managing with limited resources. This results in an increased interest to acquire cost-effective manufacturing capacity that can quickly produce the new therapies for delivery to patients. Building a new biopharmaceutical manufacturing facility can take years, and for biotech companies working on drugs in the early phases of development, it is not always a valuable capital investment. Conversely, there are risks associated with relying on a contract manufacturing organization (CMO) to bring your product to market. They may not have manufacturing capacity available or the required expertise or critical equipment needed to fit the unique needs of your molecule, and the resources they do have available are shared amongst other customers, hence production slots are limited. There are many viable options that offer fast deployment and a flexible, scalable manufacturing capability in a new or existing space that is under your control. It is essential as well as challenging to evaluate the cost, timeline, and other variables that affect your distinct situation and manufacturing needs.