Cobra Confident of Commercial Vaccibody Contract
The UK CMO was named as supplier for upcoming clinical trials last week, in a deal which will also see the firm provide the Norwegian biotech with host strain generation, cell banking and plasmid production services.
Cobra told Outsourcing-pharma.com that it “has developed a scaleable DNA production process that would be suitable for commercial supply of Vaccibody’s DNA vaccine” adding that the fill finish facility it bought in Matfors near Sundsvall, Sweden in 2011 could also support production.
“Cobra is, therefore, uniquely qualified with regards to both facilities and technical capabilities to support Vaccibody during their clinical trials and eventual commercial supply. We are already supplying a commercially available vaccine.”
Production platform
Vaccibody’s DNA vaccines use a targeting technology that combines an antigen unit, a dimerization centre and a targeting molecule that preferentially attaches to molecules on the surface of antigen presenting cells (APC).
When they are internalised by APCs, the peptides of the antigen unit are presented to CD4+ T cells which then interact with receptor B cells that in turn present them as antigenic peptides thereby conferring immunity.
The firm’s lead candidate – which Cobra will be producing – is a VB 10.16, a DNA vaccine designed to prevent HPV-induced malignancies, such as precancerous lesions found in cervical cancer.
Unlike traditional vaccines, DNA vaccines are produced using recombinant strains of E.coli, which Cobra claims will make for speedier production.
“For DNA vaccine production Cobra has established a platform manufacturing approach which shortens production time and reduces the COGS. In fact, Cobra has over 14 years of experience producing DNA vaccines for human clinical studies.”
The UK CMO expects to have completed production by the end of 2013 and clinical trials to start in early 2014.
