Immunoassay Development

immunoassayTGA Sciences, Inc. offers our clients a complete package of development, optimization and quantification systems utilized in pre-clinical through Phase IV studies, all in compliance with GLP and cGMP requirements when requested by the client. There is an additional charge for GLP and cGMP methods as compared to R&D projects.

We have a strong track record of expertise in the development of complex and infrequently used methods to assist our clients in their research. We offer weekly progress reports and/or teleconferences to ensure the client is up to date on all aspects of their projects.

 

Capabilities include:

  • Measurement of small molecules, peptides and large proteins for R&D or product release (cGMP)
  • Immunoassays for the monitoring of antibody or protein levels throughout a clinical study in complete compliance with GLP guidelines
  • Development of an Immunoassay-based screening protocol against your lead compound
  • Assay design and detection systems for antibodies with unique specifications; Quantitative detection systems for antibodies with unique specifications
  • Quantitative detection systems for the determination of contaminants in highly purified products
  • Immunoassays utilized for the detection of cytokines or cell surface markers
  • Use of commercial kits in compliance with cGMP or GLP guidelines
  • Monoclonal antibody screening (Western blot or ELISA)

Immunoassay formats include:

  • Bridging Assay
  • Competitive Technique
  • Direct Binding Assay Study
  • HACA
  • HAMA
  • Immunogenicity Assays
  • Immunoglobulin Screening
  • Isotyping
  • Client Specific Assay Formats

Additional immunoassay capabilities include: