Sterile drug products – aseptically prepared
Wide range of molecules:
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Early phase clinical supply solutions are core to Ardena. Our expertise includes phase appropriate development and manufacturing under cGMP conditions of both drug substance (DS) and drug products (DP).
We support customers with short lead times by centralizing and developing processes, analytical methods and formulations in-house. Recognized for our regulatory track record and with a multidisciplinary team of DS, DP and RA CMC experts, we expedite your project collaboratively to meet your first-patient-in targets.
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Ardena navigates your small molecule API project through route scouting, development and manufacturing under accelerated timelines. From small scale to technology transfer for commercial scale production (up to approx. some metric tons/year), we produce your drug substance with commitment to cGMP conditions.
Ardena provides leading chemical synthesis experience and manufacturing infrastructure including advanced purification technologies. Your Ardena contact will engage with you to ensure your development and manufacturing timelines are met.
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Ardena has extensive experience formulating drug products for early development. The breadth of our technologies enables us to provide a drug product that can be consistently prepared and accurately dosed, and that allows for mastering of potential solubility and bioavailability challenges.
A highly skilled team, actively supported by CMC experts, approaches formulation options in function of risk assessment frameworks. By navigating through a complex regulatory environment, a complete IMPD dossier is delivered on time.
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Ardena’s bioanalytical platform enables you to timely reach your (pre)clinical milestones. We offer solutions for all types of drug products and biomarkers, from small molecules to proteins including antibodies, antibody drug conjugates, oligonucleotides and vaccines.
Experienced in LC-MS/MS and ligand binding assays, specialized in immunogenicity analysis, and with an in-house flow-cytometry facility, we are the lead partner for your drug’s assay development and assay validation. Our bioanalytical services streamline regulatory approval.
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Ardena addresses the solid state properties of your molecule to reduce development risks and time to market. Our High Throughput Screening methodology for salt, co-crystal, polymorph, and amorphous form screening speeds up the selection of a solid form qualifying for development.
A committed project manager is at your side making it easier to identify untapped potential and to seize available opportunities. Our reporting format enables our customers to drive stakeholder discussions and strategic decision making. With a typical time frame of 6 to 8 weeks from delivery of the material, our screens are tailored to customer budget and deadlines.
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Getting the CMC regulatory aspects for your oligonucleotide therapeutic right from the outset?
Oligos find themselves in an unusual regulatory situation. Some of the standard ICH guidelines do not fully apply.
Ardena’s CMC regulatory team has gained substantial experience in this field and guides you through the regulatory framework to speed up the time to clinic.
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Ardena offers fit-for-phase clinical supply services. By printing single-panel labels in-house whenever possible, we shorten lead times and reduce costs. Supported by our GMP and manufacturing license, we provide patient kit preparation and clinical labelling solutions for both large and small molecules.
Our core expertise also covers accurately matching placebos and combined shipment of IMP, sample collection kits, and biological samples. We ensure timely supply of ready-to-use clinical trial materials with our customized labeling and packaging strategy.
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