Syngene&’s GLP-certified and US-FDA inspected Bioanalytical laboratory offers full-service solutions for evaluation of pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of biotherapeutics as well as vaccines.
Our scientists have extensive experience, working with monoclonal antibodies, recombinant proteins, enzymes, biomarkers, cytokines, vaccines and growth hormones for both pre-clinical and clinical phases of drug development.
Our services include method transfer, development, validation and sample analysis using ligand-binding assay technology and different assay formats like ELISA, MSD, cell-based and non-cell-based assays. We also offer sample management and storage; statistical analysis of immunogenicity data; report writing and data archival services.
Experience
Over the last 15 years, our lab has supported clinical programs of more than 50 biotherapeutics for submission to FDA & EMA, including 3 blockbuster drugs. We have also analyzed 600,000+ samples received from around the globe. We have experience with seven biosimilars, 22+ monoclonal antibodies and few vaccines. Our existing customers include five of the top 10 global big pharma/biotech companies and one of the top animal health companies.
Advantages of working with Syngene
- Project teams with expertise in the areas of immunogenicity and PK/TK studies
- Experienced personnel trained in GLP/GCLP
- Dedicated teams for sample management, quality control and quality assurance
- US FDA 21 CFR part 11-compliant electronic records and signatures
- ELN is implemented to record, track, review all-assay related activities by replacing the paper- based documentation
- Data capture through validated Watson LIMS™ (laboratory information management system) interfaced across immunoassay instruments
- No wait period for license and custom clearance, ~4-6 days of sample travel time from global location. Track record of zero sample compromise during shipment
Infrastructure
Syngene’s bioanalytical laboratory uses comprehensive immunoassay techniques to cater all phases of biologics drug development.
Syngene has the necessary infrastructure and technical expertise to support the following assays:
- Cell-based assays
- Fluorescence-activated cell gating and enumeration
- Electrochemiluminescence
- Luminescence
- Fluorescence and absorbance based assays
Syngene’s bioanalytical laboratory has state-of-the-art instruments and equipment comprising:
Meso scale discovery sector imager 2400 and sector imager 6000
- ELISA plate readers and washers
- Synergy 2 and Synergy HT: (Biotek) UV, visible, fluorescence
- Spectramax PLUS® 384 (molecular devices) UV, visible
- Infinite 200 (Tecan) UV, visible, fluorescence
- Biotek, ELX405 beta counter
Chameleon, VLSC 425-158 (Hidex OY) liquid scintillation
Luminescene applications
- Gamma counter
- Wizard 2, 2470-0020 automatic with 2 detectors (Perkin Elmer)
- Wizard 2, 2470-0020 automatic with 5 detectors (Perkin Elmer)
- Surface Plasmon Resonance
- Biacore T-100 (GE Healthcare)
- Cell Harvester: Filtermate (Perkin Elmer)
- Water purification system
- Milli-Q Intergral 3 (Millipore)
- Software and laboratory Information management system
- Watson LIMS™ (laboratory information management system)
Instrument software validated according to international regulations including 21 CFR part 11
- Liquid handling systems
- Tecan Genesis Freedom 150/8 workstation platform
- Tecan Freedom Evo 150/8 workstation platform
- Ultra low temperature freezers (Thermo scientific and Nuaire) and refrigerators
- Connected to temperature monitoring alarm system sensaphone
