ARE CMOS THE ANSWER?
An alternative to building or retrofitting a facility is to partner with a CMO. Indeed, innovator companies have started looking
at the strategic benefits of engaging CMOs to support their products throughout their lifecycle: in general, it is likely
that the CMO's facility and quality systems already meet regulatory requirements, including international regulations; an
innovator company can choose a CMO in a particular location (or locations) as there continues to be significant CMO business
development in Singapore, Israel, Japan, and the BRIC countries (Brazil, Russia, India, and China); CMOs are differentiating
themselves by increasingly offering specialized technologies and services, and several major CMOs are engaging the innovator
companies by exploring alternative business models. In addition, companies have access to CMOs that are already prepared to
not only manufacture a myriad of products, but also provide you with technologies and personnel already in place to "hit the
ground running" in support of your project needs.
One of the benefits of working with a CMO is that in some instances the IP holder for a particular expression system is the
CMO (for example, G-Pex/Catalent; GS/Lonza; BI-HEX/Boheringer Ingelhiem; CHEF-1/CMC Biologics), or a technology may be available
to the CMO (SURE (Selexis), UCOE (Millipore)/Eden Biodesign) and accessing it through the CMO may allow your company to obtain
preferential business terms. Discussion of available options that may be most appropriate for the production of your product
should be based on your company's supply requirements (current and future); your available budget; any target product delivery
date(s); and your company's risk tolerance and regulatory strategy.