Syngene offers a wide range of clinical lab and bioanalytical services to support all the phases of clinical development. Syngene is committed to providing excellent service, superior sample management and accurate results.
Bioanalytical Laboratory For Large Molecules
Syngene's GLP-certified Bioanalytical Laboratory for Large Molecules specializes in immunogenicity and pharmacokinetic (PK) analysis of biologics and biosimilars. The laboratory has extensive experience in working with monoclonal antibodies, recombinant proteins, enzymes, biomarkers, cytokines and growth hormones during the early and late phases of the drug development (preclinical and clinical) process.
Syngene’s Bioanalytical Laboratory for Large Molecules offers the following services:
- Method transfer and validation of radioactive and non-radioactive immunoassays, surface plasmon resonance assays (label free), electrochemiluminescence assays, chemiluminescence assays and cell based assays.
- Immunogenicity assays (screening, confirmatory, titre assessment, antibody isotyping and cell based neutralizing antibody assays).
- Pharmacokinetic/toxicokinetic (PK/TK) assays (including ISR)
- Validation of assays according to international guidelines and regulations
- Sample management and storage
- Statistical analysis of immunogenicity and PK/TK data
- Report writing
- Data Archival
Partnering with Syngene’s Bioanalytical Laboratory for Large Molecules offers the following advantages:
- Expertise in immunoassay, development, validation and large scale sample analysis as per regulatory guidelines.
- Wide range of assay formats and instrumentation.
- 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.
- Data capture through validated Watson LIMS™ (Laboratory Information Management System) interfaced across immunoassay instruments.
Bioanalytical Laboratory for Small Molecules
Syngene's Bioanalytical Laboratory for small molecules provides Method development & Validation and PK services to support Bioavailability (BA), Bioequivalence (BE) and Pharmacokinetic (PK) studies. We also undertake bioanalysis for Therapeutic Drug Monitoring (TDM) studies.
The laboratory has been inspected and approved by USFDA, ANVISA (Brazil) and EMA.
With state-of-the-art instrumentation including API 4000 and API 6500, the laboratory provides GLP-compliant services with good turnaround times. Each activity is closely monitored by the QA team to ensure compliance with SOPs, protocol as well as applicable national and international regulations.
Partnering with Syngene's Bioanalytical Laboratory (BAL) for Small Molecules offers the following advantages:
- Expertise in various types of analyses (LC-MS/MS analysis of small molecules/peptides/enantiomers/large molecules)
- Flexible business model offering services on standalone basis (bio analytical alone) or as part of BA /BE / Clinical PK study (phase I, phase II) / TDM studies and preclinical studies.
Syngene's Central Laboratory is one of the most experienced labs in India offering laboratory services exclusively for clinical studies, BA/BE studies and research projects. In 2002, it became the first laboratory in India to be accredited by the College of American Pathologists (CAP). Our central laboratory is also NABL ISO 15189:2012 accredited and NGSP certified for HbA1c testing. Our central lab is also the Intercontinental Referral Laboratory for LabCorp Clinical Trials to provide local testing services for global studies.
The main areas of specialization include biochemistry, haematology, coagulation, histopathology, immunohistochemistry, flow cytometry, clinical pathology, Microbiology and biomarkers.
Partnering with Syngene’s Central Laboratory for clinical development services offers the following advantages:
- State-of-the-Art instrumentation and quality Systems that meet global standards.
- Laboratory Information Management System (LIMS) that complies with US FDA CFR 21, Part 11 and ensures high standards of data integrity.
- Well established quality control systems through internal QC processes and participation in external proficiency testing programs.
- Qualified and experienced laboratory personnel and project management teams
- Value-added services including assay validation and development, consultancy and training
Clinical biomarkers offer objective measurements of biological processes to assist in the diagnosis and management of health conditions. During clinical trials, these measurements provide data to predict outcomes in terms of safety and efficacy. The utility of clinical biomarkers is often marred by the challenges of selecting the right assay in an appropriate quality framework to obtain reliable, accurate and quality data for analysis.
Syngene offers a wide array of biomarkers across therapeutic areas to support clinical and epidemiological research. Equipped with a wide range of technology platforms, we provide clients optimized solutions to identify and set up biomarker assays in tissues, body fluids and cell based systems. In addition to helping clients select the right tool, Syngene ensures that assays are developed, validated and established under OECD-GLP certified or ISO15189 and College of American Pathologists (CAP) accredited quality systems to provide reliable and valid data. With over 10 years of experience in providing biomarker support to global clients, our experts provide scientific insight and add strategic value to your clinical drug development programs.
We have a strategic alliance with Pacific Biomarkers Inc. (PBI), a market leader in biomarkers for CVS, diabetes and metabolic disorders, to offer novel biomarker development and testing services to the global drug development community.
Syngene offers flexible solutions, supporting clients for both standalone biomarker assay requirements and also for biomarker requirements as a part of larger integrated clinical development programs. We offer the convenience of a single point of contact with our project management department with easy ’on demand’ accessibility to our scientific team to support client requirements.
Syngene’s Clinical Biomarker services include:
• Assay development and validation services.
• Establishing proof of concept.
• Multiplatform validation services.
• Establishment of assays at commercial scale.
• Development of companion diagnostic tests.