Indicai : Biotechnology

Custom assay development

Indicia Biotechnology, immunotechnology specialist offers an outsourcing alternative to internal assay design & development to meet biocompanie’s needs in different fields of application: biomarker quantification, immunomonitoring, anti-drug antibody detection, pharmacokinetic, quality control method, companion test, in vitro clinical diagnostic…


Our offer is based on conventional or innovative technologies:

  • ELISA (Enzyme linked ImmunoSorbant Assays) are the most widespread solid phase immunoassays for the quantification of molecules in biological samples 
              Sensitivity: few ng/ml to few pg/ml
  •  xMAP™ from Luminex®, a multiplex suspension bead array for a simultaneous multi-analyte quantification within a single sample 
               Sensitivity: few pg/ml
  •  Erenna® from Singulex Inc, an ultrasensitive technology to measure biological molecules sample - the Erenna technology was recognised by the 2009 Frost & Sullivan best practices Award 
               Sensitivity: femtogram scale (10-15 g/ml)


We have developed an expertise on different assay formats: indirect, direct, capture, competitive and bridging formats.



Method Validation


Validations of assays are patterned after:

  • the current FDA "Guidance for Industry - Bioanalytical Method Validation" of May 2001 and/or
  • the current EMEA “Guideline on validation of bioanalytical methods – Committee for medicinal products for human use” – November 2009

For Clinical In Vitro Diagnostic tests, some specific studies are add in the validation step like long term stability study and shipment study.

Moreover, a clinical validation is often necessary in order to demonstrate the performance and the pertinence of the assay in the application targeted before CE marking.

Indicia supports some clients in regulatory affairs (clinical study organization, CE marking, …)

 

Related technical services

  • Monoclonal and Polyclonal Antibodies development
  • Antibody purification from ascite, immunserums or culture supernatants by different ways : precipitation, protein A/G, affinitity column, immunodepletion
  • Custom conjugation and labelling: biotin, peroxidase, alcalin phosphatase, fluorochromes, latex beads 

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