Immunoassay and Companion Diagnostics

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 our cGMP facility. 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

Process Documentation (cGMP/ISO 13485 compliant) for in-house production including:

• Incoming Raw Materials and acceptance criteria
• Process Documentation (Batch Records, SOPs, Work Instructions)
• Raw Material Qualification
• Performance, Stability, and Process Validation
• Microbial Enumeration and Antimicrobial effectiveness