Ardena
Comprehensive Drug Development and Manufacturing Services

Drug development and manufacturing is an intricate process. Evidently, it’s a tough grind for biotech and biopharma companies to create a fit-for-phase formulation and manufacturing strategy, mitigate risks, and ensure compliance—simultaneously. Moreover, these companies often struggle to maintain consistency of documents and in-time filings for smooth dossier approval, increase time efficiency, and enable the development of precision medicines (targeted delivery.) A siloed, sequential and fragmented approach to drug development may lead to poor and delayed distribution of information, causing duplicate work and even rework, particularly in early phase development where study design is subject to continuous change.

While early phase drug development entails several challenges, Ardena, a multi-service Contract Development & Manufacturing Organisation (CDMO), is moving the needle by assisting small-to-mid-sized biopharma companies with services spanning the full development life cycle. The company offers a comprehensive ‘Make, Analyse, File’ model from drug substance and drug product manufacturing, bioanalytical services, through to regulatory dossier development. Headquartered in Belgium, Ardena operates and caters to its clients across several sites in the Netherlands, Sweden, and Latvia.

Harry Christiaens, CEO of Ardena, says, “We strongly believe that our multidisciplinary approach can accelerate the drug development and approval process. By seamlessly integrating our services, we’re able to better mitigate development risks and ultimately reduce time-to-clinic.” Moreover, Ardena’s comprehensive service portfolio provides convenience to customers who no longer have to deal with multiple vendors; “we coordinate development programs, streamline communication and reduce any contracting burden,” Christiaens adds.

Ardena offers an integrated services platform to reduce the timeline of drug development, from initial idea to first-in-human (FIH) clinical verification. The platform’s make, analyse, and file capabilities to reduce the complexity and risks associated with Phase 1 timelines along with dedicated state-of-art nanomedicine development, analysis, and process capabilities. “Ardena is your reliable partner to navigate your small molecule through drug development into the clinic. In essence, we are accelerating molecules to First-in-Human (FIT) and proof-of-concept. We integrate drug substance chemical synthesis capabilities with drug product formulation expertise, supported by industry leading solid state research competencies,” asserts Christiaens.

We strongly believe that our multidisciplinary approach can accelerate the drug development and approval process. By seamlessly integrating our services, we’re able to better mitigate development risks and ultimately reduce time-to-clinic

In addition, Ardena’s regulatory CMC experts are well versed in the informational requirements, submission formats, and approval processes of various authorities. Operating from six sites across four countries, Ardena also provides global clinical supply services, covering management of clinical supplies, kitting, primary and secondary packaging. Ardena is also uniquely positioned to meet bioanalytical needs by offering quantitative bioanalysis in all phases of pharmaceutical development, qualitative and semi-quantitative analysis for metabolism studies, in-house method development, and validation according to international regulatory guidelines.

Ardena holds extensive experience spanning all types of oral and liquid drug products, with particular formulation expertise in modified release, solubilisation, spray drying, and lipid systems. This is coupled with Ardena’s specialised bioanalytical expertise in oligonucleotides in different matrices such as plasma, CSF, and tissues using hybridisation-ELISA along with specific expertise in the analysis of nanoparticles and analysis of ADCs. Using a dossier centric approach, the company focuses on the compilation of reports based on data generated in R&D and/or GMP environment, writing CMC (quality) sections for IMPD/IND and MAA dossiers, upgrading existing dossiers in terms of lay-out and readability while conforming to the current regulatory guidelines, a compilation of DMF (US) / ASMF or CEP (EUR).

Currently, Ardena is producing oral dosage forms under GMP-conditions and providing clinical logistics services for COVID-19 related pulmonary or acute inflammation indications. The company is partnering with CROs for method development, method validation, and bioanalysis of a PK assay for the determination of a monoclonal antibody against COVID-19 by ELISA and for a PK assay for hydroxychloroquine in human plasma. Ardena has also collaborated with clinical-stage biotech companies targeting mitochondrial diseases with the supply of powder for reconstitution, and the required clinical logistics for a COVID-19 focused clinical trial. Christiaens notes, “Our ability to adapt drug product formulation and bioanalysis program specifically to the requirements of the respective clinical trials is proving to be a highly attractive service offering.”

Drug development is not amenable to a one-size-fits-all approach. Together with its customers, Ardena tailors the development approach and synchronises its services with clinical timelines. “We provide high quality services underpinned by leading edge science at the core to everything we do,” ends Christiaens.