ServicesBioassay Development and Validation

BSR and its experienced scientific staff provide the scientific services to efficiently develop or qualify immunologic and cell-based assays for proof-of-concept through clinical and manufacturing

Bioassay development and validation can be done in the following areas at Biofyl Scientific Research:

  • Blood cells
  • Platelets and Plasma Proteins
  • Complement
  • Coagulation and Contact Plasma Systems
  • Enzyme Kinetic Assays
  • ELISAs

Our Bioassay Development and Validation at BSR includes: Kinase Phosphorylation (e.g. SMAD, Akt, PI3, HER2/ErbB2, Erk1/2), Cell Differentiation (Mesenchymal: Osteogenic, Adipogenic and Chondrogenic; Hematopoietic Stem cells: CFU-E, BFU-E, CFU-GEMM, CFU-GM, CFU-G, CFU-M). Cell Cycle Determination ( P21), Serum Complement (CH50), Platelet Function (aggregation, growth factor release, p-selectin expression, osmotic stress), Lymphocyte and Granulocyte Function (Stimulation, Cytotoxicity, Cell number, Viability, Apoptosis), Cell Migration (modified Boyden chamber, membrane and semisolid media) and Stem Cell Function (colony formation and differentiation).

BSR will qualify commercial immunoassay kits when available. Compendial assays or Commercial assays with sufficient documentation on performance and acceptance criteria are employed by BSR after qualification for sample matrix and any special conditions for the intended application. Other assays are validated according to best industry standards including: FDA “ Guidance for Industry: Bioanalytical Method Validation” CDER 2001; and ICH Q2(R1) “Validation of Analytical Procedures: Text and Methodology”.

In addition, Biofyl Scientific Research also offers the following services: