Idifarma, based in Pamplona, Spain, offers a full range of services spanning the pharma lifecycle from formulation, analytical to manufacturing services for highly potent drugs. Its capabilities include a platform for an accelerated path to clinic and spray drying processes to overcome solubility issues, said Ardena.
Established in 2001, Idifarma now has 120 employees.
Harry Christiaens, CEO of Ardena, said the deal expands the CDMO’s pharmaceutical technology footprint, positioning it to capitalize on the emerging biotech segment and broader pharmaceutical market. “In partnership with GHO Capital, we will continue to focus on both organic growth and acquisition opportunities to create an internationally recognized drug development company.”
The acquisition price and conditions were not disclosed.
In terms of how exactly this acquisition allows Ardena to exploit the continued growth in the biotech arena, a spokesperson told BioPharma-Reporter:
“Emerging biotech companies tend to use partnering business models for development and manufacturing. Candidate molecules and target product profiles are more complex (e.g. high potency) and can require more specialized enabling technologies to advance (e.g. spray drying). The deal will accelerate Ardena’s growth in the growing drug product market for highly potent compounds and is strengthening Ardena’s technology platform at the same time, including spray drying under containment. Furthermore Ardena services platform offers emerging biotech companies the solution to solubility and bioavailability challenges they face in their drug product pipeline.”
In July we reported on how Ardena was investing €35m (US$41.3m) in expansion projects across its European operations.
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.
Ardena’s COO, Gerjan Kemperman, told us back then the company was 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.”
Capacity for large molecule biologics would also be expanded 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.
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.