Headquartered in Belgium, the contract development and manufacturing organization (CDMO) works across several sites in the Netherlands, Sweden and Latvia. It tends to assist small-to-mid sized biopharma with services spanning the full development life cycle.
The company said it is to significantly widen drug product services in Belgium.
"The Belgian site for drug product formulation and development will expand into aseptic fill and finishing capacity for early phase development i.e. small volumes, not commercial volumes. At present, we are mainly outsourcing this specific activity," Ardena’s COO Gerjan Kemperman told us.
Capacity for large molecule biologics will also expand to include peptides, oligonucleotides (DNA, recombinant RNA, synthetic RNA, RNA vaccines) and proteins. The CDMO said this expansion project will provide clients with a full-service solution from formulation development, analytical method development and validation, demo batch production, stability studies, GMP batch production, QC testing, labelling and randomization, QP release, storage and shipping through to regulatory support.
Boosting filtration, lyophilization capacity
The drug substance/API manufacturing sites in the Netherlands and Sweden will see the bulk of this investment, said the COO.
The Swedish facility will undergo expansion to support the commercialization of COVID-19 vaccines and further growth of the API business, with the idea of enabling more preparative chromatography and HPLC and further expansion of advanced and specialized filtration technology along with lyophilization capacity for bulk quantities.
Major improvements are set for Ardena's Netherlands facility, including increased cleanroom space, chemical manufacturing capacity, warehouse space, and additional chemistry and analytical labs.
The move will also see investment in new technologies to support Ardena’s work in the field of nanotechnology.
"We believe that nanoparticle based drug delivery systems will see continuous growth after the approval of the vaccines against COVID-19 that deliver mRNA via lipid nanoparticle systems. Their efficiency and safety have been approved after Phase 3 clinical studies and we expect to see more of these type of programs in cancer treatment," continued Kemperman.
GHO Capital Partners LLP, a specialist investor in healthcare, together with the existing management team, acquired Ardena in January last year, from Mentha Capital.