The firm manufactures Redipor, a range of prepared microbiological media products used by biomanufacturers to grow cells, and has announced today the completion of an expansion at its facility in Bicester, UK.
Cherwell has doubled the size of its cleanroom manufacturing suite and added more staff, citing an increase in demand for its products from both the UK and Europe (where it uses third party distributors), but this is being led by increased vigilance and regulatory expectation for environmental monitoring, according to Sales Manager Andrew Barrow.
Perhaps twenty years ago it was traditional for firms to manufacture their own media in-house, he told Biopharma-Reporter.com, but since there has been a big move towards buying from a third party in within pharma sector.
With stringent standards such as the US Food and Drug Administration’s (FDA’s) Quality Control For Commercially Prepared Microbiological Culture Media, “few pharma companies of any size would make environmental monitoring media in-house because of the requirement for sterile irradiated packs,” he said.
“Increasing vigilance and regulatory expectation for environmental monitoring,” is driving the demand for pre-prepared media, and is coming from all sectors of the industry, he continued, with particular interest from small biotech and CMOs.
“As big pharma companies outsource development and clinical trials production they pass on their own strict requirements for monitoring and QC,” he told us.
Cherwell uses third-party distributors outside its native UK, and said demand was also coming from overseas, with export sales for its Redipor range up 55% in the past two years.