TGA Sciences, Inc. is a contract research laboratory providing the Pharmaceutical, Biotechnology and Research communities a comprehensive range of laboratory services in support of research and clinical studies. We offer the client a complete package of customized testing systems utilized in pre-clinical through Phase IV studies, all in compliance with cGLP and cGMP requirements. We specialize, and have extensive experience in, the development and validation of immunoassay systems for the detection of target molecules, antibody responses and quantification, all in total compliance with QA and cGMP standards. TGA Sciences, Inc. also offers in vivo mouse studies for the optimization of vaccine immunization schedules, dosing, adjuvant screening, immunogenicity testing for the release and stability of bulk and finished clinical product, as well as complete antibody development programs. Also available is Guinea pig dermal sensitization testing for the identification of contact allergens. All programs are supervised by an in-house Institutional Animal Care and Use Committee (IACUC), while the facility is USDA registered and AAALAC accredited. Other services provided include FACScan cell labeling studies, RIA, tissue culture, sample storage, specimen collection kits with on-site training, data management, protocol generation (SOP), database/statistical analysis and consultation. TGA Sciences, Inc. has the credentials your project is searching for.

Assay Development

TGA Sciences, Inc. offers the client 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 clear track record of expertise in the development of complex and infrequently used methods to assist our clients in their research. Working as an extension of the clients laboratory, we offer client consultations and progress reports at each phase of development.

• General assay development for the measurement of small molecules, peptides, and large proteins from research grade to GMP compliance quality.
• Qualified immunoassays for monitoring antibody or protein levels throughout a clinical study. These systems range from direct binding assays to competitive techniques and RIA’s.
• Assay design and detection systems for antibodies with unique specifications.
• Quantitative detection systems for the determination of contaminants in highly purified products, (ie: allergen preparations used for clinical studies).
• Immunoassays utilized for cytokine detection or cell surface markers.
• Commercial or customized bioassays
• Immunoassay consultation

Assay Validation

TGA Sciences, Inc. has extensive experience in the cGMP/cGLP validation of assays in support of your clinical trials. We specialize in customized immunoassay systems for the detection of target molecules, antibody responses and quantification all in total compliance with QA and cGMP standards.

• Standard curve, reference and sample reproducibility to assess assay variability and evaluate inter/intra assay variances.
• Freeze-thaw stability analysis of standard and references.
• Beginning to End Variation to assess well positioning or edge effects.
• Sensitivity determination for LLOQ.
• Spike and Recovery analysis designed to evaluate sample preparation and matrix effects.
• Evaluation of incubation times and temperature to assess assay robustness.
• Negative cutoff determination for distinguishing positive vs. negative assay response.
• Validation of commercial kits for cytokine detection or cell surface markers.

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.).

Sample Handling and Analysis

TGA Sciences, Inc. experience in Quality Assurance ensures a total understanding of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) that our clients can utilize from pre-clinical through Phase IV clinical studies.

• Specimen coding to provide immediate access and tracking throughout the sponsor's clinical study.
• Sample storage includes validated temperature sensitive chambers that are in complete compliance with GMP guidelines.
• Sample preparation techniques developed in response to the client’s requirements for a precise and accurate analysis.
• Clinical sample handling and analysis are performed in accordance with GMP guidelines, including in-house or sponsor documented assay SOP’s, for the development of products in compliance with FDA guidelines.
• In-house Quality Assurance documentation system
• The in-depth experience and GMP training of our analysts ensure that all analysis are performed in a professional manner.
• Assembling of specimen collection kits for our clients’ clinical sites along with customized collection and shipment procedures as well as on-site training of personnel.

In Vivo Animal Studies

TGA Sciences, Inc. offers the client experience in animal studies for research and clinical applications.

• The development and performance of in vivo mouse studies for the optimization of vaccine immunization schedules, dosing and adjuvant screening.
• Immunogenicity testing for the release and stability of bulk and finished clinical product, as well as raw material screening.
• Complete antibody development programs are available from immunization to purification, all performed in compliance with GMP requirements.
• Guinea Pig Maximization Test using the method of Magnusson and Kligman for dermal sensitization testing for identifying contact allergens in humans.
• Antibody and/or ascites production tailored to the specific requirements of each R&D project or clinical study.
• An internal Institutional Animal Care and Use Committee (IACUC) in accordance with USDA and HHS regulations and guidelines.
• AAALAC accreditation
• USDA registered facility

FACS Analysis

TGA Sciences, Inc. can assist the client in creating the necessary analysis and options that ensures the accurate identity of specific cell populations by phenotype and function.

• Immunocytochemical staining for apotosis studies, tissue culture cell staining studies, phenotyping or in vitro blood cell staining using high throughput FACScan techniques.
• Immunoglobulin screening and staining.
• Epitope mapping.
• R&D of sample preparation systems and analytical techniques.

Data Management

TGA Sciences, Inc. takes pride in offering our clients computerized study management, tracking and documentation for efficient, accurate database construction and data preservation.

• Protocol writing (Standard Operating Procedures)
• Customized reporting (ie: bound, unbound, disc, formatted database, and a variety of electronic formats).
• Progress reports on project status
• Technical laboratory reports
• Statistical analysis
• Statistical report and summary
• Database construction
• Graphical presentation of data
• All analytical data is permanently archived and available upon request.

Other Services Include

• Human IgE reactivity studies to evaluate your lead compound allergic response potential.
• Basic research support to meet issues raised through academic or FDA review.
• Data management: technical reports, database construction, protocol writing (SOP), etc.
• Chemical conjugation of peptide or small molecule to immunogenic carrier molecules for assay development.
• Identity testing for vaccine finished product lots (cGMP).
• Consultation

47 Hall Street
Medford, MA 02155
Tel (781) 393-6910
Fax (781) 393-6894
info@tgasciences.com

Allergy Research Foundation, ALS Research Institute, NEMC, Amphotech, Inc., Xenova Research, Ltd., Merck and Company, AltaRex Corporation, DYAX Corporation, Merrimack Pharmaceuticals, Unither Pharmaceuticals, Inc., Shire Biologics, Inc., Ortec International, Inc., EntreMed, Inc., GlycoGenesis, Inc., Sanofi-Synthelabo, Inc., Lampire Biological Laboratories, Inc., Organogenesis, Inc.

Contact Information

TGA Sciences, Inc.
Michael Settles, President
47 Hall Street
Medford, MA 02155 USA
Phone: 781-393-6910
Fax: 781-393-6894
E-mail:

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