Our pharmaceutical pilot batch manufacturing service
The manufacture of pilot batches is an essential stage in the development of any new drug. CDM Lavoisier, an expert in pharmaceutical contract manufacturing, puts its know-how at the service of pharmaceutical companies to support them at this stage, offering them customized, high-performance solutions. Every year, our company manufactures hundreds of batches of injectable drugs, both pilot and industrial sizes, in glass vials as well as glass and plastic ampoules.
What is a pilot batch?
A pilot batch is smaller than a standard industrial batch. Usually, the size of a pilot batch will represent 10% of an industrial batch. For instance, if an industrial batch contains 100,000 ampoules, the pilot batch will only contain 10,000. The pilot batch is often used as part of a drug development project.
The production of a pilot batch meets several objectives :
- trial batch to validate a manufacturing process ;
- batch used for submission of a marketing authorization application ;
- lot for the addition of a new industrial site as part of a technology transfer or a change of subcontractor ;
- experimental or pre-production batches during formulation or industrial development stages.
The importance of representativeness to the process
Whether pilot or industrial, each drug batch follows a particularly detailed manufacturing and control process. Representativeness of the industrial process means ensuring that the conditions and results obtained during small-scale production (as with a pilot batch) faithfully reflect those of large-scale production.
The manufacture of the pharmaceutical pilot batch must reproduce the normal manufacturing conditions of an industrial batch, following the same constraints.
Pilot batch manufacturing steps
The manufacturing steps for a pilot batch of injectable drugs are exactly the same as for an industrial batch :
- Sourcing of components and raw materials ;
- Quality control of these components and raw materials ;
- Solution preparation ;
- Solution filling ;
- Terminal sterilization with overheated water ;
- In-process and finished product quality control ;
- 100% visual inspection ;
- Product packaging ;
- Batch release ;
- Traceability of operations in the batch file.
The process strictly follows GMP standards (Good Manufacturing Practices). Pilot batches are often used to conduct stability studies as part of the registration of a marketing authorization dossier or the submission of a variation for the addition of an industrial site.
Our factory has the necessary authorizations to manufacture a pilot batch :
- EU-GMP
- ISO 13485
Advantages and constraints of a small batch size
For any manufacturer, profitability is often achieved through high production rates and large batch sizes. Nevertheless, the manufacture of small batches meets a major need in the pharmaceutical world. CDM Lavoisier can therefore manufacture batches from a few hundred to a few thousand units :
- pilot batch for registration or testing ;
- clinical batch for studies ;
- hospital preparation and compounding for limited needs ;
- orphan drug with a small population to treat.
The flexibility of our organization enables us to offer a capacity adapted to the manufacture of batches on a very small scale, while maintaining reasonable costs.
The use of pilot batches in the development of injectable drugs enables us to validate hypotheses while reducing costs.
Services related to pilot batch manufacturing
CDM Lavoisier offers a comprehensive range of services for the manufacture of pilot batches :
- Laboratory development of drug formulation ;
- Industrialization and validation of the manufacturing process ;
- Development of the sterilization cycle ;
- Validation of the line cleaning process ;
- Development of analytical methods ;
- Container-content interaction studies.
These services are offered for products in glass vials, glass ampoules and plastic ampoules (BFS). Our comprehensive range of services enables customers to entrust us with the entire drug development cycle, from industrial development to pilot batches and mass production.
