US contract services firm KBI Biopharma announced on 25 June 2009 that it has started using the PER.C6 platform for cell line generation as part of its offering to meet growing demand for biomanufacturing services, whether they are to produce biologicals, biosimilars or vaccines.
On 6 May 2009, DSM Biologics and Crucell already announced that their joint venture Percivia had entered into an agreement with KBI Biopharma to provide cell line generation services of the PER.C6 cell line for licensees of the technology.
As reported by Gareth Macdonald in In-Pharma Technologist, in recent years Big Pharma’s R & D focus has begun to shift away from small molecule drugs towards biologicals, which are less susceptible to generic competition and hence loss of revenue.
For example, a survey by IMS Health predicted that the biologicals market will grow 11-12% this year while, in May, the Tufts Center for the study of drug development reported that the number of therapeutic peptides in clinical study has nearly 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 2009, joining Percivia and Avid Bioservices that have been providing cell line services in the country for the last few years.
KBI CEO Mr 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.
Part of the reason for the PER.C6 technology’s popularity is related to its high production potential. In June 2008 a Percivia team reported that they had achieved a new record yield with the XD process of 27 g/L for antibodies.
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, in the US.
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.
Source: Crucell, DSM, IMS Health, In-Pharma Technologist, Percivia, PRNewswire, Tufts
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