Address:
47 Hall Street
Medford, MA 02155
UNITED STATES
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Contact Info:
T: (781) 393-6910
F: (781) 393-6894
Company Contacts:
Michael Settles
President
Website URL:
www.tgasciences.com/
Year Established: 1998
Employees: 8
Sales: 1,000,000
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Organization:
TGA Sciences, Inc.
About Us
TGA Sciences, Inc. is a contract research laboratory located in Medford, MA that provides laboratory-outsourcing support for the Pharmaceutical, Biotechnology and Academic communities.
Products / Services:
ASSAY DEVELOPMENT / VALIDATION:
Development of an immunoassay-based screening protocol against your lead compound.
Antibody specificity screening.
Chemical conjugation of peptide or small molecule to immunogenic carrier molecules for assay development.
Assay development and validation (in accordance with CDER guidelines) for GLP / cGMP applications.
Sample analysis using process control methodology.
Use of commercial kits under cGMP guidelines.
Immunoassay consultation.
SAMPLE HANDLING
Providing clinical sites with sample collection kits and on-site training.
Clinical trial sample testing and storage capabilities.
Specimen coding.
Sample storage in validated temperature sensitive chambers.
ANIMAL STUDIES
AAALAC accredited animal rooms.
Monoclonal antibody generation (in vivo, in vitro, intrasplenic).
Immunogenicity testing in combination with selected adjuvants, for the testing of the release and stability of bulk and finished clinical product, as well as raw material screening.
Guinea Pig Skin sensitization studies (USDA registered).
Use of an internal Institutional Animal Care and Use Committee (IACUC) in accordance with USDA and HHS regulations and guidelines.
QUALITY CONTROL
Documentation - In-house Quality Assurance documentation system.
cGMP technician training program.
In-house metrology and calibration programs.
Identity testing for raw materials testing (cGMP - TNA, osmolarity, pH, LAL, etc.).
OTHER SERVICES INCLUDE:
Human IgE reactivity studies to evaluate your lead compound allergic response potential.
RIA development.
FACScan analysis: apoptosis studies, tissue culture cell staining studies, epitope mapping, etc.
Basic research support to meet issues raised through academic or FDA review.
Data management: technical reports, database construction, protocol writing (SOP), etc.
Markets Served:
Pharmaceutical, Biotechnology and Academic communities.
Other Categories this company can be located in
Analytical
Animal Services
Basic Research
Compliance
Contract Research
Drug Development
Process Development
Validation and Studies
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