Affinity Life Sciences

Affinity Life Sciences was established in 2005 as a cGMP (21CFR820) and ISO 13485 compliant contract manufacturing organization that is committed to providing exceptional service, cost-effective solutions, and meeting the highest quality standards for our clients. We offer custom contract development and manufacturing services to the diagnostic, medical device, and pharmaceutical industries providing a single source for supply chain management, process and product development, and contract manufacturing.

Affinity is a strategic partner you can trust throughout all stages of your project: from research and development to commercialization of your product. Our dedicated staff provides expertise in lyophilization, reagent manufacturing, immunoassay and companion diagnostics, cell culture services, protein chemistry, and client specific projects.

Affinity understands that each project is unique and our team offers the experience, flexibility, and attention to detail that will make your project a success. Affinity offers more than contracting services: our goal is to fully collaborate with our clients resulting in a true partner relationship that results in project success.

Commitment to Quality

• Affinity Life Sciences, Inc. is committed to faithfully meet our client’s needs, strictly adhere to regulatory requirements, and provide products and services of the highest quality.
• As a medical device manufacturer, 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.