Lyophilization Services

Affinity 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:

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

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.  In addition, Affinity provides a host of support services including cell culture, protein chemistry, and testing services providing a unique, “one-stop-shop” for the medical device and pharmaceutical industries. 

Quality Control

Every aspect of production, from raw material acquisition through the shipment of product, 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 each product will meet our customers’ production requirements.