CDMO Recipharm has extended its drug product manufacturing license to include immunology products, expanding its biologics offering.
The license applies to the firm’s facility in Wasserburg, Germany. It covers microbiological testing which allows Recipharm to carry out bacterial endotoxin testing on its customers’ products.
“Certain bacteria (gram negative bacteria) can release constituents of their cell membrane,” general manager of Recipharm’s facility, Michael Isele told BioProcess Insider. “Bacterial endotoxins can only be destroyed by dry heat exceeding 300°C. Constituents of drug products or packaging components, except glass barrels, do not withstand such high temperature, so bacterial endotoxin contamination cannot be removed in the manufacturing process, but has to be controlled through the entire production process, including the incoming testing of drug product constituents.”
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Previously, Recipharm had to outsource to test for bacterial endotoxin. However, the Wasserburg facility has the capacity to perform this test inhouse and with the license Recipharm can fill any vaccine. “However, restrictions arise when the vaccine is classified in a higher biosafety level,” Isele said.
The firm added the license will also allow the testing of diluent for COVID-19 vaccines. Last month, Moderna contracted Recipharm to supply fill-finish for its mRNA COVID-19 vaccine.
The accreditation includes gel electrophoresis, biologic analytical techniques, UV/VIS spectrophotometers and osmometers. The facility has also scaled-up its packaging capabilities to support its customers with packaging.
Isele told us its ability is reflected in the extended manufacturing license and “the capacity of the site is for sure limited but not impacted.”
“The extension of the manufacturing license opens the opportunity for Recipharm’s facility in Wasserburg to enlarge its product portfolio and to offer its excellent service for fill / finish operations of aseptic drug products in liquid and lyophilized form with higher quality standards/services to a wider clientele.”
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