Quality assurance by design
Located just outside Cambridge, an internationally recognised centre for scientific innovation, Cambridge Pharma’s state-of-the-art facility is purpose-built to support drug product development.
Our facility houses cGMP sterile filling rooms, a packing room, a process development pilot laboratory and a cGMP analytical laboratory. From the specification of our clean rooms and isolator contained filling lines, to the flows of people and material, every aspect of our facility has been designed to enable speed and flexibility while maintaining strict contamination control and the highest levels of quality assurance.
GMP sterile manufacturing facility
Our cGMP-compliant fill-finish production area has been designed from the ground up to incorporate unidirectional flow and segregation of people and material, ensuring the most robust contamination control and sterility assurance.
The facility can handle a wide variety of products, including oncology and cytotoxic materials, small molecules and non-active biologics. Our state-of-the-art isolator contained filling lines will also accommodate a wide range of solution viscosities, suspensions and gels.
Key features and technologies include:
- Fast turnaround and shortened lead-times
- Fully flexible isolator based process equipment
- All filling conducted within Grade A isolators
- Qualified peristaltic or piston pump filling systems
- Flexible filler to accommodate a range of primary containers
Cambridge Pharma’s Pilot Laboratory operating to GMP standards is a dedicated clean space designed to offer the flexibility necessary to carry out rapid process development, technical transfer activities and validation.
Our experienced team of pharmaceutical scientists and manufacturing engineers can offer the full range of process development services, with particular expertise in specialist primary containers and integrity testing.
The Pilot Lab is purpose-built to cater for:
- Early stage mixing studies
- Stability batch filling
- Process optimisation and characterisation
- Container closure integrity development and testing
Cambridge Pharma’s analytical laboratory is equipped to perform raw material identification, in-process and final product testing under cGMP conditions.
In addition to expertise in material analysis and stability testing, our scientific team have extensive experience in physical assessment, including the force testing of drug containers such as pre-filled syringes.
The GMP Lab has the capability to perform a range of different tests including:
- Assay (HPLC)
- Related substances (HPLC)
- Identity testing (HPLC)
- Particle size analysis (PSD)
- Force testing
- pH assay