Testing Services

Affinity Life Sciences, Inc. is a CRO/CMO providing expertise in in vitro / in vivo assays, bioanalytical services, and client-specific studies. Affinity works directly with all clients, to design and execute protocols that meet the specific objectives of each project.  Our staff can develop and validate assays, source commercial assays for transfer and validation, and/or transfer client developed methods.  We are dedicated to being a flexible and cost-effective partner while exceeding our client’s quality expectations.

Our Capabilities Include:

• In vitro Testing / Bioanalytical Testing
  Biomarker / Immunoassay Method Development and Validation
  Binding Assays and Enzymatic Activity Assays
  Anti-Drug Antibodies (ADA)
  Immunogenicity / Immunology / Toxicology
  Host Cell Proteins
  Human & Mouse IgG Isotyping / Quantification
  Electrophoresis and Western Blot (Purity / Identification)
  HPLC (Purity / Identification)
  UV Analysis
  Client-Specific Analytes
• In Vivo Testing
  Customer specific Cell-based Assays
• Testing Platforms
  Multiplex Aushon’s SignaturePLUS™ CCD Imaging & Analysis System
  ELISA Colorimetric and Chemiluminescence
  Microscopy (IHC)
  HPLC
• Extensive Documentation (cGMP / ISO 13485 / GLP compliant) to meet strict quality standards

Quality Control

Every aspect of development, production, and testing can be documented in our Quality System documentation which is GLP/cGMP and ISO 13485 compliant. Through careful monitoring and strict adherence to our Quality System documentation, Affinity Life Sciences ensures that our services will meet or exceed our customers’ requirements.