Lyophilization Services
cGMP MEDICAL DEVICE LYOPHILIZATION SERVICES AND DIAGNOSTICSAffinity Life Sciences offers lyophilization services with expertise in formulation, cycle development, and production. Our New England based facility is cGMP compliant for the manufacture of medical devices and in vitro diagnostic (IVD) test components. Affinity’s full service contract research and manufacturing organization can provide services that range from development to commercial release. Affinity can also provide research and development services for our biopharmaceutical and pharmaceutical clients under strict documentation:
Affinity has extensive formulation and process knowledge with the lyophilization of small molecules, proteins/peptides, antibodies, and nucleic acids; either bulk or vialed.
LYOPHILIZATION SERVICES CAPABILITIES
- Formulation and Cycle Development
- Filling of Vial/Bottle sizes 0.5 mL to 125 mL
- Complete Labeling and Packaging Services
- Inventory Storage
- Analytical and Biochemical testing
- HPLC, analysis for purity
- Karl Fischer, moisture analysis
- UV/VIS, concentration determination
- ELISA and Client Specific Assay
- Microbial Testing
- Client specific Performance, In-Process, and Stability
Affinity’s staff has extensive formulation and process knowledge with the lyophilization of small molecules, proteins/peptides, antibodies, and nucleic acids; either bulk or vialed.
Quality Control
Every aspect of development, production, and testing can be documented in our Quality System documentation which is cGMP and ISO 13485 compliant. Through careful monitoring and strict adherence to our Quality System documentation, Affinity Life Sciences ensures that our services will meet or exceed our customers’ requirements.
