Clinical Batches I-II
Experience and Capabilities
Over the past 25 years, Unither Développement Bordeaux has acquired deep expertise in Phase I and II drug product development and manufacturing. These very early stages are critical, and demand flexibility and agility in order to rapidly begin initial clinical trials.
Unither Développement Bordeaux manufactures all dosage forms for clinical batches, whether developed by our teams or by our customers.
An ICH stability program is mandatory to determine the expiration date of the drug product. The expiration date will be extended during the program after each positive result of a stability checkpoint.
By keeping both product development and manufacture of clinical batches under one roof, tech transfers are avoided, and the product is scaled up in the same environment, by the same personnel, using the same equipment, greatly diminishing the chance of problems.
All batches are manufactured using Master Batch Records (MBRs) to ensure accountability and traceability of all operations. After Quality Control and review of the batch records, the Qualified Person issues a GMP (Good Manufacturing Practice) certificate, allowing release of the packaged clinical trial material.
Importation of Comparators for
Clinical Trial Trials
Unither Développement Bordeaux was granted importer status by ANSM (Agence Nationale de Sécurité du Médicament). The company is authorized to buy, import, control, and release drug products as comparators from all countries for use in clinical trials.