In recent years Big Pharma’s R&D focus has begun to shift away from small molecule drugs towards biologics, which are less susceptible to generic competition and hence loss of revenue.
For example, a survey by IMS Health predicted that the biologics market will grow 12 per cent this year while, in May, the Tufts Center for the study of drug development reported that the number of proteins in development has doubled in the last decade.
As a result, the demand for stable, well characterised cell lines for industrial biomanufacture has increased dramatically with the PER.C6 technology, developed by Crucell and partner DSM, emerging as one of the most popular platforms.
To meet this growing global demand Crucell and DSM have developed a network of regional manufacturers capable of supplying PER.C6 services through a series of licensing agreements.
North Carolina based KBI became part of the US network in May, joining Percivia and Avid Bioservices which have been providing cell line services in the country for the last few years.
KBI CEO Joseph McMahon said there is “significant market interest in and adoption of [the PER.C6] technology,” and added that the platform is a good fit for the firm’s in house cell line development expertise.
PER.C6 for vacc production
Part of the reason for the PER.C6 technology’s popularity is related to its high production potential. In June last year a Percivia team reported that they had achieved a new record yield of 27 g/L.
This productivity was one of the reasons that Swiss drugmaker Novartis selected the PER.C6 line for its cell culture vaccine production plant in Holly Springs, North Carolina.
While Novartis’ adoption of PER.C6 happened years before the H1N1 “swine” flu began the technology's utility and speed advantages over traditional egg-based flu vaccine production will certainly be seen as beneficial for the rapid production of an effective vaccine.