Our clinical batch manufacturing service
Are you looking for an industrial partner to manufacture a drug clinical batch ? CDM Lavoisier has been manufacturing injectable drug batches for third parties for many years. We have the know-how and industrial capacity to produce clinical batches.
What is a clinical batch?
A drug product clinical batch manufacturing is related to the production of a small batch used in a clinical trial. The laboratory manufactures a quantity of finished product ranging from a few hundred to a few thousand units, specifically to meet the needs of a clinical study carried out on a limited cohort of patients.
The clinical batch follows the same manufacturing process as a pilot batch or industrial batch. It complies with the same quality standards and regulations to guarantee patient safety.
Steps in manufacturing a clinical trial batch
The manufacturing steps for a batch of injectable drug intended for a clinical study are as follows :
- Sourcing of components and raw materials ;
- Quality control of these components and raw materials ;
- Solution preparation ;
- Solution filling ;
- Terminal sterilization ;
- In-process and finished product quality control ;
- 100% visual inspection ;
- Product packaging with appropriate labeling (anonymization) ;
- Batch release ;
- Traceability of operations in the batch file.
Our factory has the necessary authorizations to manufacture medicines for human use in accordance with Good Pharmaceutical Manufacturing Practice (GMP) :
- EU-GMP
- ISO 13485
Placebo manufacturing
CDM Lavoisier is also able to manufacture the placebo to be used in a double-blind comparative study on drugs in liquid form. Here are just a few examples of solutions we can manufacture for use as a placebo :
- water for injection ;
- sodium chloride 0,9% ;
- glucose.
Services ancillary to clinical batch production
In addition to batch manufacturing, we can also support you in the development of industrialization processes, or the validation of processes and methods. We also carry out stability studies. Lastly, we offer product blinding via a specialized partner.
These services are available for products in glass vials, glass ampoules and plastic ampoules (BFS).
