Based in Belgium, the Contract Development and Manufacturing Organization (CDMO) works at several sites in the Netherlands, Sweden and Latvia. It tends to help small and mid-sized biopharmaceutical companies with services spanning the entire development lifecycle.
The company has announced its intention to significantly expand pharmaceutical services in Belgium.
“The Belgian pharmaceutical formulation and development site will expand to aseptic filling and finishing capacity for early stage development, ie small volumes and not commercial volumes. At present, we mainly subcontract this specific activity ”Ardena’s COO, Gerjan Kemperman, told us.
The capacity of large molecule biologics will also be extended to include peptides, oligonucleotides (DNA, recombinant RNA, synthetic RNA, RNA vaccines) and proteins. The CDMO said that this expansion project will provide customers with a full service solution ranging from formulation development, analytical method development and validation, production of demonstration lots, stability studies, GMP batch production, quality control testing, labeling and randomization, QP release, storage and shipping. regulatory support.
Reinforcement of filtration, freeze-drying capacity
The drug / API manufacturing sites in the Netherlands and Sweden will see the bulk of this investment, the COO said.
The Swedish facility will be expanded to support the commercialization of COVID-19 vaccines and further growth of API business, with the idea of enabling more preparative chromatography and HPLC and expanding further advanced and specialized filtration technology as well as freeze-drying capability for bulk quantities.
Major upgrades are planned for Ardena’s facility in the Netherlands, including increased cleanroom space, chemical manufacturing capacity, warehouse space, and additional chemical and analytical laboratories.
The move will also see investments in new technologies to support Ardena’s work in nanotechnology.
“We believe that nanoparticle-based drug delivery systems will experience continued growth following the approval of COVID-19 vaccines that deliver mRNA via lipid nanoparticle systems. Their efficacy and safety have been approved after phase 3 clinical studies and we expect to see more such programs in the treatment of cancer ”,Kemperman continued.
GHO Capital Partners LLP, a specialist healthcare investor, with the existing management team, acquired Ardena in January of last year from Mentha Capital.