Affinity Life Sciences
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Amherst, New Hampshire, US
Affinity Life Sciences was established in 2005 as a 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's goal is to fully collaborate with our clients resulting in a true partnership.
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.
Affinity Life Sciences can provide antibody/protein purification and conjugation services while adhering to strict quality control measures. We can also assist our customers with the identification of raw material sources, in the development of polyclonal or monoclonal antibodies, and in the development of protocols or methods that will specifically meet your needs.
Examples include the following types of services:
QUALITY CONTROL
All purified antibodies/proteins and conjugates will be analyzed by electrophoresis, specificity testing, and/or chromatography techniques (FPLC or HPLC) to meet customer defined parameters. Once these specifications are met, the product will be stored or shipped with a certificate of analysis (COA) stating all tested customer-specified parameters of product quality were met. This service provides the customer with traceability and lot-to-lot consistency during the production of your components.
Affinity Life Sciences provides cost effective cell culture services for the production of recombinant proteins using mammalian cell lines (CHO and others) and bacterial cell lines (E.Coli or others). We can also provide development of monoclonal antibodies or your clone can be provide to Affinity for antibody production. Affinity also provides growth of microorganisms for quality control testing of in-process or production materials.
Using various production methods such as roller bottles, hollow fiber, and WAVE Bioreactor, Affinity Life Sciences can optimize production and develop specific formulations and conditions for your cell line to improve performance and quality.
Our production facility is fully equipped to provide our customers complete service including:
Affinity Life Sciences can provide our clients with assistance in assay design, development, enhancement, and production of their immunodiagnostic test. Our staff has over 20 years of immunoassay development and manufacturing experience and can provide technical and quality expertise to aid our customers through the design and production of their in vitro diagnostic test.
Affinity Life Sciences also offers process validation services for the manufacturing of your kits and components. In this capacity we can assess the performance of your assay and determine whether test results are within acceptable ranges. Typical validation testing would include accuracy, precision, sensitivity, linearity, and stability studies. Our Quality department will work with each customer to determine the proper validation protocols and test methods needed to meet their requirements.
List of Services
Affinity Life Sciences offers lyophilization services with expertise in formulation, cycle development, and production. 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:
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.
Reagent components (diluents, standards, controls, calibrators, buffers, and other solutions) manufactured at Affinity or provided by our customers can be filled, sealed, labeled, and packaged per customer requirements. These components may then be used individually or packaged as in vitro diagnostic kits or custom specific kits.
Affinity Life Sciences can also develop and formulate these reagent components in-house according to customer specifications. All processes are fully documented within our Quality System documentation.
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