The certification awarded by Sweden’s Medical Products Agency (Läkemedelsverket) builds on current GMP for biologics at Cobra’s mammalian antibody and recombinant protein production facility in Södertälje, adding the quality control (QC) testing of registered products.
This means the plant can now offer commercial QC testing as either a standalone product or as part of a full biologics manufacturing contract, and is anticipated to boost business, according to Cobra spokesperson Lara Jupp.
Jupp told Biopharma-Reporter.com that currently QC testing at Cobra's facility in Matfors, Sweden (acquired as part of the Unitech Pharma Group takeover in 2011), is outsourced to a third party. However, she said, “going forward we endeavour to increase the independence of Cobra’s Quality Control, and internalise these services utilising our own operational capabilities.”
QC analysis and testing for biologics is more challenging than with small molecule drugs, Jupp continued, due to the complexity of the material and interaction with buffer systems. “Many traditional and newly developed analytical techniques need to be employed in order to characterise and understand biologics material.”
Furthermore, “biologic materials also require consideration of factors, such as environmental impact, that may impact stability (shelf life) or activity.”
The facility – which already has approval for the manufacture of active substances by culturing mammalian cells, the storage of both mammalian and microbial cell banks, and the release testing of protein for clinical trials – recently added a new 1,000L bioreactor in response to growing customer demand.
During a visit to the facility in November by Biopharma-Reporter.com, site manager Ulrike Ljungkvist said the firm had opted for Thermo Fisher’s Hyclone bioreactor at the site in order to shorten production lead times, and the validation work should be completed next month.
Talks with the MHRA
The contract manufacturer also spoke to us about its ambition for its small scale DNA and microbial facility in Keele, UK.
“It is our aim to enhance the site's capability by expanding the Manufacturing Licence to cover the manufacture and testing of both clinical and commercial products,” said Claire Docksey, Head of QA and Qualified Person (QP).
“An initial, favourable discussion has taken place with the MHRA, with final approval dependent on implementation of a full commercial systems infrastructure.”