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Immunochemistry Capabilities

GLP Immunochemistry Services

The immunochemistry group has experience in the development and validation of assays for the measurement of therapeutic drugs, synthetic peptides, monoclonal antibodies, viruses, various growth factors, hormones and cytokines. We have also validated qualitative assays for the detection of antibodies to peptides and proteins.

We have conducted a wide variety of studies, both preclinical and clinical, which involve:

  • Development of validation of custom assays
  • Implementation and validation of an existing method
  • Optimizing a method and then validating
  • Validation of an existing diagnostic kit

GLP Cell based Assays

Alta's immunochemistry group also maintains a cell culture facility that offers the development and validation of cell based assays. The group has experience with assays for the measurement of various cytokines and neutralizing antibodies to these cytokines.

Automated Instrument Data Acquisition and Report Generation

The immunochemistry group utilizes Innovative Automation's ALIS-IC 2000™ (Automated Laboratory Information System) as its database management and reporting system and Brendan Scientific's StatLIA™ for automated instrument data acquisition. The combination of the two eliminates all manual entry of data (after sample receipt). All regulatory and validation documentation is stored electronically. This streamlined system allows the immunochemistry group to efficiently handle large studies and generate custom study reports to fit the needs of the client.

Assays in Validation*
* validation in human serum/plasma
IL-2 bone specific alkaline phosphatase
IL-10 N-telopeptides
IL-11
IL-12
TNF alpha
VEGF
Hepatocyte growth factor
MMP-9
TIMP-1

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