Immunoassay Development

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TGA Sciences, Inc. capabilities include:

TGA 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. 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

About TGA Sciences

TGA Sciences, Inc. is a contract research organization (CRO) that provides its Pharmaceutical, Biotechnology and Academic clients a comprehensive range of laboratory services in support of basic research and development as well as for clinical studies. We offer a complete package of customized testing systems utilized in pre-clinical through Phase IV studies, including custom assay development, in vivo animal studies, cell-based assays, various immunological-based testing, as well as sample storage. We serve clients both in the U.S. and internationally.

All of our services are in compliance with cGLP and cGMP requirements. We are FDA registered, EMA Certified, AAALAC accredited, DEA licensed and USDA registered, and we have a comprehensive Quality System with a dedicated QA/QC Director to ensure that internal, customer and regulatory requirements are met.

To learn more about our services, request a quote or schedule an audit, please contact us using the form on the left, or contact Michael Settles at msettles@tgasciences.com or 781-393-6910 x203.