Since inception, bio-analytical services has been a core competency at Lotus Labs, and constitutes a key service offering - to cater to the analytical testing requirements of our clients spanning the pharmaceutical and biotechnology domains. At Lotus Labs, we offer comprehensive bio-analytical services. Our bio-analytical services cover a broad spectrum of activities that include method development & validation from several human matrices such as blood, serum, plasma & urine, analyze complex molecules for Phase I plasma samples. Lotus bio-analytical services has developed and validated more than 250 methods.
Lotus Labs houses a fully GLP-compliant centralized bioanalytical facility at Bangalore with state-of-the-art laboratories managed by highly skilled and experienced scientific professionals and support personnel. Our capabilities in bioanalytical services has ensured the development of over 230 validated bioanalytical methods with the wherewithal to analyze over 25000 samples per month. This translates into faster turn-around time for development and validation for new molecules.
All analytical methods are developed and validated in line with international regulatory requirements with assurance of precision recovery and stability checks. While all systems use validated software that is CFR 21 Part 11 compliant all bioanalytical services ensure the highest of quality standards and ISR in compliance with guidelines. All data are electronically transferred and documented and all studies are scrutinized by the QA Department and subjected to periodic in-house audits to ensure compliance.
Value Proposition
- Comprehensive list of assays
- Quick turn-around times
- Expertise in handling various matrices (blood plasma serum urine & whole blood)
- Competencies to handle liquid-liquid extractions solid-phase extractions and pre-column / post-column derivatization procedures
- Chiral separation of optical isomers
- Conjugate and non-Conjugate drug level estimation
- Expertise in handling wide range of regulatory audits
Infrastructure
The analytical facility at Lotus Labs spread over 20 000 sq ft is equipped with cutting edge capabilities that comprise 13 units of LCMS/MS -MDS Sciex which includes:
- API 5500 - I
- API 4000 - 5
- API 3200 - 2
- API 3000 - 4
- API 2000 - 1
Besides our lab is equipped with 4 HPLC units in addition to Auto Samplers Biological Sample Extraction units Ultra Water Purification system spacious wet labs positive & negative pressure sample extraction unit air handling units fume hoods and more.
Lotus Labs has an independent lab to process light sensitive molecules.
The fully validated and regulatory compliant Waters SDMS software at Lotus Labs ensures movement of data seamlessly from the analytical lab to documentation within a CFR Part 11 compliant environment.
All study samples at Lotus Labs are stored in secure freezers with temperatures ranging from 2°- 8° C - 20° C and -80° C. These freezers are monitored round the clock with power backup and have a combined capacity to store close to 1 million samples.
Services
The bioanalysis service portfolio from Lotus Labs ensures that sponsors get a complete program that includes
- Drug and/or metabolite(s) assay for pharmacokinetic studies
- Therapeutic drug monitoring- drug assay and concentration data interpretation
- Enantio selective determination
- Extensive list of available assay in body fluids
- Rapid new method development
- Custom method development & validation services for drug and metabolites
- Up-to-date LCMS/MS GC instrumentation HPLC instrumentation and FPIA instrumentation