CDMO looks to strengthen its presence in Belgium, Sweden and the Netherlands
In partnership with GHO Capital, Ardena, a contract development and manufacturing organization (CDMO) supporting the biopharma industry, is investing $41.3 million toward expansion of its operations in Europe.
Ardena will be expanding drug product services in Belgium and aseptic fill-and-finish capabilities for the development and clinical production of small molecule, injectable formulations. Capacity for large molecule biologics will expand to include peptides, oligonucleotides (DNA, recombinant RNA, synthetic RNA, RNA vaccines) and proteins.
The multimillion-dollar commitment, Ardema said, will offer clients a full-service solution from formulation development, analytical method development and validation, demo batch production, stability studies, good manufacturing practice (GMP) batch production, quality control (QC) testing, labelling and randomization, qualified person (QP) release, storage and shipping through to regulatory support.
Ardena’s facility in Sweden will expand in order to support the commercialization of Covid-19 vaccines and further growth of the active pharmaceutical ingredient (API) business. This will allow for more preparative chromatography and high-performance liquid chromatography (HPLC) and expansion of advanced and specialized filtration technology, along with lyophilization capacity for bulk quantities.
As for the Netherlands location, the investment program will focus on major improvements in continuing the growth of the API and nanomedicine fields. This will include the expansion of cleanroom space (Grade D and C), chemical manufacturing capacity, warehouse space, adding chemistry and analytical labs and investing in new technologies to support Ardena’s knowledge in nanotechnology.