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CONTRACT MANUFACTURING
Medical Device and Pharmaceutical

Affinity Life Sciences is a GMP and ISO 13485 compliant company and is committed to the specific needs of the diagnostics, medical device, and pharmaceutical industries.

Lyophilization Services

LYOPHILIZATION SERVICES

Formulation, cycle development, and production in our cGMP facility

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IMMUNOASSAY & COMPANION DIAGNOSTICS

Assay Design, Development, Enhancement and Production

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CELL CULTURE

Cost effective cell culture services for the production of recombinant proteins or monoclonal antibodies

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Reagent Manufacturing

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cGMP and ISO 13485 compliant contract manufacturer, dedicated to the diagnostic, medical device, biotechnology and pharmaceutical markets.

Affinity has been a trusted partner for over 10 years providing our clients with the highest quality service at a reasonable price.

Reagent Manufacturing
Reagent Manufacturing

Affinity provides complete supply chain management, from ordering raw materials to distribution of final reagents, ensuring our clients have a single-source for their projects. Our goal is to keep expenses down, quality high, and deliveries on-time, every time.

Lyophilization Services
Lyophilization Services

Our lyophilization services include 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.

Immunoassay Services
Immunoassay & Companion Diagnostics

Affinity’s services include assay design, development, enhancement, and production of your immunodiagnostic test. Your manufactured components can be fully validated, kitted, stored, and ready for shipment.

Cell Culture
Cell Culture Services

Affinity provides cell culture services for hybridoma antibody production, recombinant protein production by mammalian and bacterial cell lines, and microbial production. Our services include production, purification, subcloning, and cell banking.

Protein Chemistry
Protein Chemistry Services

We specialize in purification of antibodies and recombinant and native proteins, including conjugation of proteins, drugs, and small molecules. These molecules are used in diagnostic tests, validation studies, high-throughput screening and a host of other products and tests.

Custom Services
Custom Services

Many clients require specialized formats, formulation, or production processes. At Affinity, we provide solutions in a cost-effective manner. Our experienced team has an established network of validated suppliers to ensure your unique product reaches market on-time and with the highest quality.

Our dedicated team is ready to discuss your contract manufacturing and lyophilization needs. 

DEDICATED TO QUALITY. NO EXCEPTIONS.

We take Quality very seriously and it is the hallmark of our manufacturing capabilities. Our employees have extensive training and experience in the medical device industry and are chosen based on their commitment to quality and customer service.

Our Quality System has been developed to meet the requirements of the cGMP Quality System Regulation (FDA 21 CFR Part 820) and the ISO 13485:2003 international standard.