Catalent’s CHO cell lines and Gate’s Foundation to make PATH Malaria vaccine
Under the agreement Catalent Pharma Solutions will manufacture therapeutic antibodies at its facilities in Madison, Wisconsin.
PATH’s MVI anti-infection vaccines are being developed to prevent infection from the Plasmodium falciparum malarial parasite. The project is supported by the Bill & Melinda Gates Foundation.
Catalent will provide cell lines for the biomanufacturing of the MVI’s preclinical candidates, to enter clinical trials for malaria.
Mike Riley, VP & General Manager of Catalent Biologics said "PATH is a leader in the field, working with partners to pioneer vaccine development approaches that could someday contribute to malaria elimination efforts. We are excited to be able to apply our technology and expertise to advance this important programme," in a statement.
CHO cell lines
Catalent’s GPEx platform is a pseudo-typed vector range of Chinese hamster ovary (CHO) mammalian cell lines.
Benefits of the GPEx platform include higher yields. For example, the firm claims its CHO-S line is able to produce fed-batch titers with yields up to 7.0g/L.
At around 5 months, the GPEx platform is also speedier than other typical development times, which take around 18 months, and is already in use in over 34 clinical trials.
Last August the non-profit signed a deal with CMC Biologics for cGMP manufacturing of MVI’s antibody using CMC’s CHEF1 cell lines. This week it was also announced CMC Biologics has been bought for over $500m.
Madison biomanufacturing
The Madison facility, which was bought from GE Healthcare back in 2011, has over 100,000 sq ft of cGMP production space with bioreactors up to 2000L after a $34m upgrade in August this year.
An ambr15 and GPEx workstation will allow microscale batches of product to be produced under cGMP conditions.
Amber15 is a microbioreactor system from Tap Biosystems – now owned by Sartorius Stedim Biotech Group – which was integrated with Catalent’s GPEx platform and upstream processing services last year.
