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. Our services combine top-notch scientific knowledge with cutting-edge tech, ensuring precise and high-quality results. We know the importance of timely, accurate, and reliable data for 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. Recently, Lambda proudly received the ‘Industry Partner of the Year‘ Award at the Global Generics & Biosimilar Awards 2023. 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 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