Processing Services and Contract Manufacture
Biological materials can be processed (in bulk) in a variety of ways e.g. using standard serum treatments, filtration or lyophilisation. Cell culture services are also available providing off-site cell line handling and storage options. All processing services are performed to your own specifications in one of our Class 5 ISO 13408-7:2012 rated cleanrooms.
- Aseptic production: All processing services are performed using fully disposable, single-use systems in one of two Class 5 cleanrooms (ISO 7 rated laminar flow hoods) validated to ISO 13408-7:2012 guidelines for the aseptic processing of healthcare products that cannot be terminally sterilized.
- Flexible service options: whether that be a simple product treatment process, or a more hands-on cell culture based project, we will deliver a complete solution based on your specific requirements.
- Quality Assured Manufacture: All products are handled according to ISO9001:2015 standards. Every product processed by LSP is fully supported by complete documentation for full traceability.
- In addition, storage facilities at ambient, +4°C and -20°C, together with warehouse space enable the offsite storage and drop shipment of materials as required.
Examples of services that can be provided include:
- Serum treatment: Various serum products including FBS, Human AB Serum and other animal sera can be processed (in bulk) by charcoal stripping, dialysis, heat inactivation or gamma irradiation. Catalogue products can also be processed in this was as an off-the-shelf option.
- Cell Culture Services: A variety of cell culture services are available, from the simple to the more complex.
- maintenance of cell lines
- adaptation of cell lines to serum-free conditions
- passaging of cell lines
- large scale production of cell lines and antibody harvests
- cell banking
- Filtration: Biological materials such as serum and plasma that have been aseptically collected from approved sites can be processed at LSP. Filtration is typically performed using single use systems offering triple filtration to 0.1 micron. Typical volumes that can be processed are from 1 to 1,000 L.
- Lyophilisation: Materials can be dried either as a standalone service, or as part of a Product Manufacturing Service.
- Vial fill and finish: Save on importation costs by shipping materials in bulk. LSP can re-dispense biological and media based products pre-defined vessels and capped to predefined specifications.
- Quality assurances services: A comprehensive range of bioanalytical services are available including sterility, ELISA, endotoxin, bacterial and viral screening. In addition, we can also provide species testing. All appropriate Certificates of Analysis (COA) will be made available, based on the test results for each batch of manufactured product.