Drug Substance Compounding
Eurofins Sinensis provides GMP certified compounding that guarantees the highest standards in manufacturing your product. The compounding process will be executed according to your determined procedures.
If necessary, the process can be designed in close collaboration with Eurofins Sinensis.
Require formulation of small scale batches?
Our expertise lies at manual small scale GMP manufacturing of liquid, cytotoxic, biological and sterile products. This includes:
- Clinical trial material (all phases)
- Small scale commercial batches
Other small scale projects can be discussed. Feel free to contact us to discuss whether Eurofins Sinensis can be a partner in your (pharmaceutical) project.
Our compounding service
The quality of your compounding process is assured as the complete process is performed in class C cleanrooms that are equipped with class A BioSafety Cabinets. Aseptic Fill & Finish activities are performed in class B cleanrooms with class A BioSafety Cabinets.
All manufacturing processes use fully disposable contact parts avoiding the need for cleaning. This includes:
- Polymer bag mixing systems
- Sterile filters and tubing assemblies
- Peristaltic filling pumps
Further, Eurofins Sinensis offers complete solutions to deliver your final products with the highest standards.
Testing compliant to international pharmacopeia
Raw materials, excipients and in-process samples are tested in compliance with international pharmacopeia before release to the compounding or Fill & Finish unit. Eurofins Sinensis is one of the few contract laboratories that is WHO prequalified (full list of certificates and qualifications).
Scaling your compounding process
Scalability of the process is an important step in pharmaceutical development. Eurofins Sinensis can be your guide in studying the possibilities of scaling your compounding process and can facilitate in the following in-house services:
- 6 week delivery. For the entire process from compounding to Fill & Finish, up to labelling, packaging and shipment.
- All services internally available. The size and diversity of Eurofins Sinensis allow us to guide you through the full process of small scale GMP manufacturing.
- Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.