Providing Clinical Laboratory and Bioanalytical services for clinical development programs
Syngene offers a wide range of Clinical Laboratory and Bioanalytical services that support all phases of clinical development with a commitment to provide excellent service, superior sample management, and accurate results.
Capabilities
Syngene has well-equipped bioanalytical laboratories for both small molecules and biologics, a well-accredited central laboratory, and over ten years of experience in providing a wide array of biomarker services.
Bioanalytical laboratory for biologics
Syngene’s good laboratory practice (GLP) certified laboratory specializes in evaluation of pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of biotherapeutics. We have extensive experience working with monoclonal antibodies, recombinant proteins, enzymes, biomarkers, cytokines, vaccines, and growth hormones in the early and late phases of the drug development process, both preclinical and clinical. Our experts are trained in good clinical laboratory practices (GCLP) and are familiar with a wide range of assay formats and instrumentation.
Services offered by the bioanalytical laboratory
Syngene’s experts are proficient in undertaking method development, transfer and validation of ligand binding assays in various formats such as enzyme-linked immunosorbent assays (ELISA), electrochemiluminescence (ECL) assays, radioactive immunoassays, surface plasmon resonance assays (label-free), fluorescence-activated cell gating and enumeration, luminescence, fluorescence and absorbance-based assays, and cell-based assays.
Our project team works on all phases of immunogenicity assays, including performing immunoassays, method development, validation, and large-scale sample analysis as per regulatory guidelines. As part of our immunogenicity assays, the team conducts screening assays followed by confirmatory, titer assessment, antibody isotyping, and cell-based neutralizing antibody assays. We also conduct pharmacokinetic/ toxicokinetic (PK/ TK) assays, including incurred sample reanalysis (ISR), and provide statistical analysis for immunogenicity data.
We have dedicated teams for sample management, storage, quality control, and quality assurance, and also provide data archival services and capture data using validated Watson LIMS™ (laboratory information management system) interfaced across our immunoassay instruments. We have replaced all paper-based documentation with electronic lab notebook (ELN) for recording, tracking and reviewing all assay related activities. Our report writing services comply with the US Food and Drug Administration’s (FDA) code of federal regulations (CFR) 21 part 11 for electronic records and signatures.
Bioanalytical laboratory for small molecules
Syngene’s GLP compliant laboratory provides method development, validation, bioanalysis for therapeutic drug monitoring (TDM) studies, and PK services that support bioavailability (BA), bioequivalence (BE), and pharmacokinetics (PK) studies. Our quality assurance team closely monitors each activity to ensure compliance with standard operating procedures and protocols, as well as applicable national and international regulations.
Our services are available on a flexible business model for both standalone bioanalytical services as well as for services that include BA/BE studies, clinical PK studies in phase I and phase II, TDM studies, and preclinical studies. Syngene’s bioanalytical laboratory for small molecules has been inspected and approved by the US FDA, Brazil’s National Health Surveillance Agency (ANVISA), Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency (EMA).
Central laboratory
Syngene’s central laboratory is one of India’s most experienced laboratories, offering services exclusively for clinical studies, BA/BE studies, and research projects, including value-added services such as assay validation, development, consultancy, and training. We also support clinical trial testing, especially in areas such as diabetes, cardiovascular, oncology, and immunology. Our qualified laboratory personnel and experienced project management teams specialize in biochemistry, hematology, coagulation, histopathology, immunohistochemistry, flow cytometry, clinical pathology, microbiology, and biomarkers. We have a well-established quality control system that leverages both internal processes and external proficiency testing programs.
Our central laboratory was the first in India to be accredited by the College of American Pathologists (CAP) in 2002. We also have accreditation from the National Accreditation Board for Testing and Calibration Laboratories (NABL) ISO 15189:2012 and are certified by the National Glycohemoglobin Standardization Program (NGSP) for hemoglobin A1c (HbA1c) testing. Our central lab is the intercontinental referral laboratory for LabCorp clinical trials that provide local testing services for global studies.
Biomarker services
Syngene has over ten years of experience in providing a wide array of biomarker services across therapeutic areas for global clients in support of clinical and epidemiological research. Equipped with a range of technology platforms, our experts provide scientific insight and add strategic value to clinical drug development programs, giving optimized solutions to identify and set up biomarker assays in tissues, body fluids, and cell-based systems.
Our services include assay development and validation, establishing of proof of concepts, multiplatform validation, establishing assays at commercial scale, and developing companion diagnostic tests. We ensure our assays are developed, validated, and established under the Organization for Economic Co-operation and Development (OECD) principles of GLP or ISO 15189, using CAP-accredited quality systems for reliable and valid data.
Our clients have the convenience of interacting with a single point of contact in the project management department, with easy ’on-demand’ access to the scientific team. We offer flexible solutions, supporting standalone biomarker assay requirements as well as assays that are part of larger integrated clinical development programs.
Syngene has a strategic alliance with Pacific Biomarkers Inc (PBI), a market leader in biomarkers for cardiovascular disease, diabetes, and metabolic disorders, which enables us to offer novel biomarker development and testing services to the global drug development community.
Infrastructure
Our state-of-the-art infrastructure includes cutting-edge instrumentation, advanced techniques, and the latest technology platforms that enable us to offer a comprehensive set of advanced services with reduced lead times and provide on-time delivery. We also perform diagnostic assays to support end-to-end trial management.
Laboratory facilities for biologics
Syngene’s bioanalytical laboratory uses comprehensive immunoassay techniques that caters to all phases of drug development for biologics. Our state-of-the-art instruments and equipment include microplate detection platforms such as Meso Scale Discovery Sector Imager 2400 and Sector Imager 6000, microplate readers such as ELISA plate readers and washers, and Molecular Devices’ Spectramax PLUS® 384 with UV-visible and visible absorbance. We also use Biotek’s Synergy 2 and Synergy HT multi-detection microplate reader, and Tecan’s Infinite 200 with UV, visible, and fluorescence detection modes.
Our instruments include Biotek’s ELX405 beta counter, liquid scintillation counters such as Chameleon and Hidex OY’s VLSC 425-158 as well as other luminescence applications. Our gamma counters comprise of Perkin Elmer’s Wizard 2 2470-0020 automatic with 2 detectors and 2470-0020 automatic with 5 detectors. The team relies on surface plasmon resonance products such as GE Healthcare’s Biacore T-100 and Perkin Elmer’s Filtermate cell harvester. The water purification systems used include Millipore’s Milli-Q Integral 3, LIMS system, and Watson LIMS™. The instrument software used in Syngene is validated according to international regulations including 21 CFR part 11.
Our facility is equipped with liquid handling systems such as Tecan Genesis’s Freedom 150/8 and Evo 150/8 workstation platforms. In addition, we also use Thermo Scientific and Nuaire’s ultra-low temperature freezers and refrigerators which are connected to Sensaphone’s temperature monitoring alarm system.
Regulated bioanalytical lab for small molecules
Syngene’s bioanalytical laboratory for small molecules spread across 7500 sq. ft. is equipped with state-of-the-art equipment. The laboratory uses liquid chromatography with tandem mass spectrometry (LC-MS/MS) instrumentation such as API 4000, API 4000 QTrap, API 4500 and API 6500 with electrospray ionization (ESI), and atmospheric pressure chemical ionization (APCI) sources to analyze small molecules, peptides, enantiomers, and biologics.
The software applications include Analyst® (LC-MS/MS) and Watson LIMS® used for bioanalytical workflow. We also use software such as Phoenix® WinNonlin® 8.1, and SAS® software to perform pharmacokinetic and statistical analysis. Assays for BA/BE Studies
Facilities in the central laboratory
Our central laboratory is located in a spacious 8000 square feet campus that is access-controlled and includes well-placed alarm systems and a wireless data logging system to remotely control temperature and humidity. All disposal of biological waste is handled through contractual arrangements. Our laboratory includes state-of-the-art instrumentation and quality systems such as Watson LIMS that complies with US FDA CFR 21 Part 11, ensuring high standards of data integrity.
