FDA gives green light to BioMarin facility expansion
pharmafile | November 29, 2011 | News story | Manufacturing and Production |Â Â Â
The US FDA has granted approval to BioMarin Pharmaceutical for a $60 million expansion of its manufacturing facility in Novato, California, that will support growth of its enzyme replacement products.
According to the company, the facility is expected to support around $1 billion in revenue for the company’s enzyme replacement portfolio, which includes complex glycoprotein products produced by mammalian cells.
The Novato facility was first licensed to produce Aldurazyme (laronidase) for mucopolysaccharidosis I (MPS I) in 2003, followed by Naglazyme (galsulfase) for MPS VI in 2005.
The expansion has doubled the capacity of the facility’s cell culture production operations, and tripled the post-purification capabilities of the plant, according to BioMarin, which noted that this has boosted its commercial-scale manufacturing requirements as well as clinical and pre-clinical development programmes.
The investment also included so-called High Temperature Short Time (HTST) technology for pre-treatment of media, which lowers the risk of viral contamination in production runs. Around 100 additional staff will be added to BioMarin’s headcount as a result of the expansion.
“The facility expansion will … be the initial site of commercial production for GALNS [N-acetylgalactosamine 6-sulfatase] for MPS IVA, if pivotal Phase III results are positive in the second half of 2012,” said BioMarin’s chief executive Jean-Jacques Bienaime.
The Novato plant will also be used to make other pipeline drugs such as PEG-PAL for phenylketonuria (in Phase II), BMN 701 for Pompe disease and BMN 111 for achondroplasia (both in Phase I).
BioMarin has also been increasing its manufacturing capacity outside the US of late, buying a 133,000 sq. ft. bulk biologics manufacturing plant in Cork, Ireland, from Pfizer in a $48.5 million deal announced earlier this year. That plant is intended to boost capacity as well as to provide some redundancy in case any production problems occur in Novato.
Bienaime said the next phase in the firm’s manufacturing capabilities expansion would occur in Ireland.
Phil Taylor
