Affinity Life Sciences

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
  

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
  

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.

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