Labs
At Lambda Therapeutic Research, we drive drug development to new heights with our state-of-the-art Lab Services, encompassing critical domains such as bioanalytical, biosimilars, and central clinical lab. These services are underpinned by a fusion of exceptional scientific expertise and cutting-edge technologies, ensuring the utmost precision and quality in every result. We understand the paramount importance of timely, accurate, and reliable data in propelling successful drug development.
Lambda Therapeutic Research stands as a beacon of collaboration, serving as your end-to-end partner for all your lab service requirements. Our global reach and expertise in diverse therapeutic areas set us apart, empowering your quest for innovative solutions and breakthroughs. Discover the Lambda Advantage today, where precision meets progress and innovation fuels excellence in clinical development.
Bioanalytical Lab
Lambda Therapeutic Research offers a comprehensive suite of bioanalytical capabilities specializing in cell-based assays, biomarkers, immunogenicity, and pharmacokinetics (PK). With state-of-the-art facilities and a team of experienced scientists, Lambda provides end-to-end solutions for the analysis of small molecules, biomarkers, biologics, and therapeutic elemental drugs. Our team has extensive experience in developing validated and qualified methods for generic and NCE molecules, including ultra-trace detection, endogenous, and chiral assays.
Bioanalytical Methods Assay List:
Access our latest assay list showcasing our extensive Bioanalytical Assay capabilities, boasting over 1400 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 46 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
- A GLP-compliant facility.
- 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
Vitamin product assay
Biphosphonate assay
Protein bound and unbound assay
Endogenous assay
Light sensitive assay
Assay for highly unstable molecules
Conjugated and unconjugated assay
Chiral assay
Hormonal product assay
Fat analysis in food and fecal
Liposomal encapsulated and un-encapsulated assay
Biosimilars & Large Molecule Bioanalysis
Full-Spectrum Offerings
Pharmacokinetic Assessment
Immunogenicity Assessment
PD/Biomarker Evaluation
Toxicokinetic Measurement
Method Development
Pharmacokinetic Assessment
The Lambda Advantage
Extensive Experience
Adalimumab
Bevacizumab
Denosumab
Filgrastim
Vedolizumab
GCSF
Glucagon
Pegfilgrastim
PEG G-CSF
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 Therapeutic Research’s Clinical Laboratory boasts state-of-the-art infrastructure, a comprehensive array of advanced equipment, and seamless logistics. With a track record spanning over 20 years, Lambda’s Clinical Lab has been a trusted provider of full-service central laboratory support for all phases of Clinical Trials. Our team of highly skilled professionals, including Clinical Pathologists, Microbiologists, Biotechnologists, and Medical Technologists, brings a wealth of expertise to deliver a diverse range of services.
The Lambda Advantage
Central lab services to meet your testing needs
Cytology
Biochemistry
Molecular Biology
Hematology and coagulation
Urinalysis
Microbiology
Assay Development
PK/PD analysis of Biomarkers/antibodies
Biomarkers
Safety Testing
Immunology & Serology
Autoimmune, inflammatory and allergy testing
PD Parameter & Biomarker Analysis
- Flow cytometer (BD FACS- canto)
- CBC (Fully automated Sysmex, XN-550)
- Cobas e411 (Electrochemiluminescence)
- D-10 Hemoglobin Testing System - Bio-Rad
- Vitros 5600 (Enhanced chemiluminescence)
- Real Time Quantitative micro PCR – Molbio
- Fully Automated Urine analyser- Cobas u601
- Commercial ELISA kits for biomarker analysis
- Coagulation Analyzer (STA COMPACT max, STAGO)
Let's Unveil New Therapies Together
Connect with our experts to leverage our proven track record of clinical research excellence.