Ardena

ArdenaEuropean CDMO supporting drug discovery from early stages to clinical development and manufacturing. In addition to formulation development and bioanalysis, we also provide services to support preclinical development such as PK animal studies. We support development not only through non-clinical studies themselves, but also from formulation and analytical perspectives.

Features of Ardena's non-clinical contract services

Comprehensive services from PK animal studies to bioanalysis

At Ardena,PK evaluation required for preclinical development of candidate compoundssupports . From the creation and review of study protocols, selection of animal species and administration routes, PK animal studies, sample collection and management, to the preparation of study reports, we provide comprehensive support. Furthermore, we can perform bioanalysis of collected samples using LC-MS/MS, ELISA, qPCR, flow cytometry, and other methods. By combining pharmacokinetic data with analytical results, we can confirm the exposure and pharmacokinetics of candidate compounds, providing the basis for decisions to advance to the next development stage.

Supporting non-clinical development with GLP-compliant bioanalysis

GLP-compliant bioanalysisThis is one of Ardena's characteristics. It supports the analysis of small and large molecules, and allows for the establishment of analytical systems tailored to your objectives, such as PK, biomarkers, and immunogenicity. The Assen facility is GLP-certified, supporting bioanalysis from the preclinical to clinical stages. Regarding analytical methods, we handle not only novel development but also the transfer of existing methods and the establishment of methods tailored to the development stage. Our strength lies in the ability to combine the necessary analyses to match the characteristics of the candidate substance and the development phase.

Development support connecting formulation development to CMC

Instead of offering preclinical studies separately,A framework capable of coordinating everything from formulation development, analysis, and manufacturing to CMC regulatory complianceWe are building . In addition to formulation development for oral, injectable, nasal, and topical products, we also support the improvement of bioavailability for poorly soluble compounds. Technologies such as spray drying, hot melt extrusion, nanosuspensions, and lipid-based formulations are available. The advantage when seeking comprehensive development support is that PK data obtained in the preclinical stage can be reflected in formulation design, connecting smoothly to subsequent GMP manufacturing and clinical trial supplies.

An example of a disease model owned by Ardena

Since Ardena is not a CRO specializing in disease models,We do not offer specific disease models as our primary service.Meanwhile, we can conduct PK and bioanalysis for preclinical candidates to evaluate pharmacokinetics, immunogenicity, and other properties. Necessary animal studies will be individually designed according to the research content.

Preclinical study cases of Ardena

Evaluate the immunogenicity of preclinical candidate proteins

Ardena advanced to a development candidate following preclinical studies in rats and monkeys.Developed an assay to evaluate the immunogenicity of endogenous protein analogsWe have published a case study of a project where we performed immunogenicity risk assessment, generated positive control antibodies, and conducted assay development and validation to quickly prepare the data required for an IND application. We established evaluation systems using rat, monkey, and human sera, and supported the preparation of non-clinical data for the initiation of clinical trials.

Ardena Corporate Information