• BioTether Sciences

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RESEARCH & DEVELOPMENT

ASSAY VALIDATION

REGULATED TESTING


BioTether Sciences operates a modern laboratory with Bioanalytical, Molecular Biology and Cell Culture Infrastructure

Excellent Research and Development Capabilities as well as a GMP and GLP compliant Laboratory:
  • Cell based potency assays and stable cell line generation
  • Clinical and non-clinical sample analysis for immunogenicity, pharmacokinetics, and biomarkers
  • Cell and Gene Therapy product characterization and vector quality control testing
  • Molecular Biology, Sequencing and Gene Expression Analysis
  • Protein engineering and characterization
  • Identity, Purity, Potency, and Stability Testing
  • Stability chambers and long term storage

Our Testing Services

BioTether Sciences wants to be your partner in developing solutions to umet medical needs. We operate a GMP and GLP compliant Laboratory, capable of handling your regulated non-clinical and clinical studies.

Technical Consulting
Medical Device Biocompatibility
​Immunogenicity Risk

​Assay Development
​GXP Compliance 


Advanced Cell Engineering
Cell Based Assays
​Cell Line Development
​Knock-out, Gene Edited and Reporter Lines
​​Primary Cell Isolation

Immunogenicity Testing
Anti-Drug Antibodies
​ELISA & ECLA
​Flow Cytometry
​Clinical Studies


Biomarker Analysis
Novel Method Development
​Disease State Biomarkers
​Mechanism of Action Studies
 

Pharmacokinetics Testing
BioTherapeutic Analysis
​Dose-Concentration Testing
​Biodistribution
Tissue and Biopsy Assays

Cell and Gene Therapy Characterization
Capsid Immunogenicity
​Vector Packaging
​Gene Copy Number
​Sanger Sequencing