Bioanalytical Services and GMP QC services
Svar Bioanalytical Services is a bioanalytical CRO centered on analyzing large molecules (biologics, peptides and proteins) and QC services for Bioassays and GMP potency testing. It provide services for non-clinical as well as Phase I – III, including Biosimilar, and post-marketing clinical studies for pharma, CRO and biotech clients.
Svar Life Sciences has experience in various disease and treatment areas including Oncology, Autoimmunity, Endocrine disorders, and Neurology with various type of treatments such as: Antibody therapeutic and Immuno-Oncology, Cell and Gene Therapy and drugs based on small and large peptides. We have worked with drugs used in large treatment indications, pediatric indications, Biosimilars and with Orphan drugs.
The experience in assay development / transfer and validation of immunoassays within our team of bioanalytical experts is extensive and they are always ready to discuss how to speed up your projects. Our mission is understanding how new assay and technology innovations, within each of these areas, can optimize and accelerate our sponsors work and deliver that expertise knowledge into the project we take on.
Our Bioanalytical Services Solutions include:
- Immunogenicity Testing - Detection and confirmation of ADAs and NAbs
- Pharmacokinetics (PK) & Pharmacodynamics (PD ) - Expertise in bioanalysis of large molecules
- Toxicokinetics (TK) testing - Assessment and characterization of biologic safety of large molecules
- Biomarker testing - Over 250 immunology markers at your service
- Potency Testing - Determinate the functional activity of your drug molecule
- Consultancy Services - Optimize your study's assay strategy and improve submission success
Our QC Services include:
-Development of GMP Bioassays
-Qualification or Validation of GMP Bioassays
-GMP Lot-Release testing
-GMP Stability testing
-GMP In-process testing
Manufacturer Svar Life Science AB | Available Worldwide
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