The license applies to the company’s Wasserburg, Germany facility
Recipharm has extended its manufacturing license to include immunology products, allowing the company to cater for customers’ vaccine products at clinical and commercial scales, in both freeze-dried and liquid forms.
The license, which applies to its facility in Wasserburg, Germany, also covers microbiological testing allowing Recipharm to insource bacterial endotoxin testing on its products, including testing diluent for one of the COVID-19 vaccines.
Kjell Johansson, President Manufacturing Services Europe said: “Vaccine manufacturing capacity and the associated testing is more crucial than ever, so we’re delighted to be able to further support our customers in the area."
“The Recipharm team has extensive experience in handling products with aseptic requirements and this accreditation is just the latest step in ultimately bolstering our biologics offering for customers. This will allow us to not only to cater for requirements for the current pandemic, but also future requirements as we continue to see more biologics enter the drug pipeline.”
The accreditation includes biologic analytical techniques including gel electrophoresis, UV/VIS spectrophotometers and osmometers, with plans to add more in 2021. In addition, the facility has also bolstered it packaging capabilities to support customers with clinical trial packaging.