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Affinity Life Sciences

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... Show more »

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.

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Affinity Life Sciences has not listed any services.

Antibody Services
Price on request

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... Show more »

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:

  • CUSTOM CONJUGATION
    • Alkaline Phosphatase
    • Horseradish Peroxidase
    • Avidin/Biotin
    • Particles (PMP, glass,latex,etc.)
    • Custom Antibody or Protein
  • DIGEST
    • Fab pepsin digest
    • F(ab)2 papain digest
  • PURIFICATION
    • Salt Precipitation
    • Protein A
    • Protein G
    • Affinity Chromatography
    • Ion Exchange Chromatography
    • Hydrophobic interaction Chromatography
    • Gel Permeation
    • Custom Chromatography

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.

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Protein Production
Price on request

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... Show more »

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:

  • Isotyping
  • Master and Working Cell Banking
  • Purification and Conjugation
  • Component and Kit Manufacturing
  • LAL Endotoxin Testing
  • HPLC Analysis, Purity testing
  • Gel Electrophoresis Analysis
  • Western Blot Analysis
  • Immunoassay Testing
  • Certificates of Processing
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Companion Diagnostic Development
Price on request

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... Show more »

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

  • Product Design and Development
  • Identification and Sourcing of raw materials including:
    • Polyclonal antibody (including production)
    • Monoclonal antibody (including production)
    • Coating Buffers and Conditions
    • Standards, Calibrators, and Controls
    • Preservatives
    • Testing Samples
  • Component Formulation including:
    • Coating Buffers and Condition
    • Blocking reagents
    • Diluents
    • Standards and Controls
    • Wash Buffers
    • Conjugation and Detection reagents
  • Product Enhancement and Optimization
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Lyophilization
Price on request

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... Show more »

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:

  • 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.

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Biochemical Reagent Manufacturing
Price on request

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... Show more »

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.

Other related services:

  • Performance Testing of individual components and manufactured kits
  • Stability Testing of all assay components
  • Process and Product Validation including all necessary documentation for the production of your assay/product
  • Assistance in:
    • Packaging and labeling
    • Package insert preparation
    • Distribution
    • CE marketing for European Union distribution
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Protein Complementation Assay
Price on request
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Biomolecular Interaction Analysis
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Biochemical Assays
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Biology
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Protein Services
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Formulation Services
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Biochemistry & Molecular Biology
Price on request
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Medical Devices & Diagnostics
Price on request
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Manufacturing Services
Price on request
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