Lab Services
Precision and Innovation with comprehensive Lab services.
Labs
At Lambda Therapeutic Research, we’re dedicated to advancing drug development with our comprehensive Lab Services, covering key areas like bioanalytical testing, biosimilars, and central clinical lab support. By combining deep scientific expertise with cutting-edge technology, we deliver precise, reliable, and high-quality results to support your drug development journey. We understand that accurate and timely data are critical to success, and we’re here to make that happen.
As a trusted partner, Lambda works hand in hand with clients, providing end-to-end lab solutions tailored to meet your unique needs. With a global presence, advanced labs, and experience across diverse therapeutic areas, we’re committed to empowering your path to innovation and breakthroughs. Recently, we were honored to receive the ‘Industry Partner of the Year‘ Award at the Global Generics & Biosimilar Awards 2023 —an achievement that reflects our dedication to excellence.
Bioanalytical Lab
Lambda provides a comprehensive range of bioanalytical services, specializing in cell-based assays, biomarkers, immunogenicity, and pharmacokinetics (PK). With state-of-the-art labs and a team of skilled scientists, we deliver end-to-end solutions for analyzing small molecules, biomarkers, biologics, and therapeutic elemental drugs. Our team brings extensive experience in developing and validating methods for both generic and NCE molecules, including advanced techniques for ultra-trace detection, endogenous assays, and chiral analysis. At Lambda, we ensure precision and reliability in every step of the bioanalytical process to support the success of your clinical development.
Bioanalytical Methods Assay List:
Access our latest assay list showcasing our extensive Bioanalytical Assay capabilities, boasting over 1500 validated methods. Our Bioanalytical Labs in India and Canada have successfully conducted diverse Bioanalytical Assays across a wide range of biological matrices. The assay list is categorized as follows:
India
- A GLP-compliant facility.
- Separate lab for photosensitive drugs.
- Fully equipped Class II cell culture lab.
- Low temperature storage (-22 ± 5 °C, -65 ± 10 °C)
- Separate room for storage of standards / balance room.
- Automated liquid handling systems for sample preparation
- Thermo Scientific iCAP RQ ICP-MS system for elemental analysis (Iron, Potassium, Bismuth etc.) from biological samples.
- Flow cytometry and CAP and NABL accredited in vitro diagnostic platforms for pharmacodynamic biomarkers measurement.
- Advanced Softwares: Biolyte (Chromatographic Data review & data printing) & BizNET (Sample inventory management)
- 21 CFR Part 11 compliant multi-mode readers for absorbance, luminescence & fluorescence endpoints measurement & MSD reader for electrochemiluminescence measurement.
- Well-equipped extraction labs and chromatography labs consisting of different types of 39 LC-MS/MS systems (including most sensitive instruments such as API 6500+, API 6500, Shimadzu 8060 and Waters Xevo TQ-S).
- 1100+ Validated Methods
- Antimicrobial activity testing: In vivo, ex-vivo, in vitro saliva, plaque, and skin flora.
- Expertise in developing and validating cell-based neutralizing anti-drug antibody assays (NAbs).
- Capabilities to analyze over 90,000 samples per month & to develop and validate 7-8 new methods for small molecules per month.
- Expertise in the development & validation of elemental drugs such as Iron Sucrose, Ferric Carboxy Maltose, Ferumoxytol, Potassium Chloride, Potassium Citrate, etc.
- ELISA, Dry chemistry, and ECLIA-based platforms for the development of PK measurement, PD analysis, and Immunogenicity assessment methods for large molecules.
- Testing expertise in handling different matrices, including plasma, serum, urine, whole blood, milk, food, stool, Biomarkers/PD testing, Safety testing, and Molecular testing of COVID-19 & HCV RNA, etc.
Canada
- Well defined area for photosensitive drugs.
- Low temperature storage (-22 ± 5 °C, -65 ± 10 °C)
- Separate room for storage of standards / balance room.
- Automated liquid handling systems for sample preparation
- Advanced Softwares: Biolyte (Chromatographic Data review & data printing) & BizNET (Sample inventory management)
- Well-equipped extraction labs and chromatography labs consisting of 6 LC-MS/MS systems (including most sensitive instruments such as API 6500+, API 6500).
- 400+ Validated Methods
- Mass identification and mass fragmentation in pharmaceutical compounds
- Ability to analyze multiple analytes in a single run for time- and cost-effective analysis.
- Testing expertise in handling different matrices, including plasma, serum, urine, whole blood, milk, food, stool.
- Strong failure investigation system for root cause analysis in case of a run/experiment failure and OOS (Out of Specification).
- Capabilities to analyze over 10,000 samples per month & to develop and validate 3-4 new methods for small molecules per month.
- Capability to conduct Analytical and Bioanalytical assays for unstable substances, metabolite back conversion compounds, endogenous compounds, liposomal products, chiral compounds, and elemental analysis.
Small Molecule Experience
- Low detection assay
- Endogenous assay
- Protein-bound and unbound assay
- Conjugated & unconjugated assay
- Vitamin product assay
- Fat analysis in food and fecal
- Light sensitive assay
- Chiral assay
- Liposomal assay
- Hormonal product assay
- Highly unstable molecules assay
- Biphosphonate assay
Biosimilars & Large Molecule Bioanalysis
Full-Spectrum Offerings
Pharmacokinetic Assessment
Immunogenicity Assessment
PD/Biomarker Evaluation
Toxicokinetic Measurement
Method Development & Validation
Quick turnaround Bioanalysis
The Lambda Advantage
Extensive Experience
Adalimumab
Bevacizumab
Denosumab
Filgrastim
Vedolizumab
GCSF & PEG G-CSF
Glucagon
Pegfilgrastim
Pertuzumab
Ranibizumab
Rituximab
rHu-FSH
Teriparatide
Trastuzumab
Romiplostim
Follicle-stimulating hormone (FSH)
Ligand-Binding Assays
- State-of-the-art laboratory
- 21 CFR part 11 compliance
- Synergy Multimode Plate Reader (Biotek)
- M-Plex Multi Mode Reader (Tecan)
- QuickPlex SQ 120 Reader (MSD)
- Dynex, USA - Fully Automated ELISA Processors
Cell-based Assays
- Fully-equipped cell culture laboratory
- Development and Validation of cell based neutralizing assays
Clinical Lab
Comprehensive Central Clinical Laboratory Services for All Phases of Clinical Trial Testing
Lambda’s Clinical Laboratory is equipped with state-of-the-art infrastructure and advanced technology, backed by seamless logistics to ensure efficient and reliable operations. With over 20 years of experience, our Clinical Lab has earned a reputation as a trusted provider of full-service central laboratory support across all phases of clinical trials. Our team, comprised of expert Clinical Pathologists, Microbiologists, Biotechnologists, and Medical Technologists, brings a wealth of specialized knowledge to deliver a wide range of services, ensuring the highest standards of quality and precision in every aspect of clinical testing.
The Lambda Advantage
Central lab services to meet your testing needs
- Biomarkers
- Immunology & Serology
- Assay Development
- Safety Testing
- Hematology and coagulation
- Biochemistry
- Molecular Biology
- Microbiology
- Cytology
- PK/PD analysis of Biomarkers/antibodies
- Autoimmune, inflammatory & allergy testing
- Urinalysis
PD Parameter & Biomarker Analysis
- Vitros 5600 (Enhanced chemiluminescence)
- Cobas e411 (Electrochemiluminescence)
- CBC (Fully automated Sysmex, XN-550)
- Flow cytometer (BD FACS- canto)
- Bio-Rad D-10 Hemoglobin Testing System
- Real Time Quantitative micro PCR – Molbio
- Fully Automated Urine analyser- Cobas u601
- Commercial ELISA kits for biomarker analysis
- Coagulation Analyzer (ACL TOP 350 CTS, STA Compact Max, STAGO)
Let's Unveil New Therapies Together
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