CGMP Clinical batches, PHASES I, II, III and IV
We manufacture clinical batches up to 50 Kg of powder or 50 l of liquid for Phase II trials. Batches of this size can also satisfy the needs of small-scale Phase III clinical trials (e.g. for orphan drugs), though it is more common to manufacture these batches at the final manufacturing site after a tech-transfer.
According to the customer’s needs, the product is transferred to one of our own manufacturing sites, or to the customers’ selected site. In all cases, our teams provide everything necessary to ensure a smooth transfer to the new environment.
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.
Leveraging our agile structure and the capacity range of our equipment (several hundred to several thousand grams or milliliters), we routinely manufacture and package orphan drugs specifically targeting rare diseases.
We also provide full development, formulation, process development, and analytical services.
Our flexibility, responsiveness, and 10-plus years of experience with this class of drug make us an ideal partner.
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.