Bioanalytical Services

Bioanalytical Services – Our Key Service Offering

Since inception in 2001, bio-analytical services have 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 domain. At Lotus Labs, we offer comprehensive bio-analytical services. Our bio-analytical services cover a broad spectrum of activities that include method development & validation (MD/MV) from several human matrices such as whole-blood, serum, plasma & urine. Lotus Labs houses a fully centralized bioanalytical facility at Bangalore with state-of-the-art laboratories managed by highly skilled and experienced scientific professionals which meets the applicable GCP and GLP requirements. Our capabilities in bio analytical services has ensured the development of over 600 validated bio analytical methods with the wherewithal to analyze over 35,000 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 current international regulatory requirements. All systems use validated software that is CFR 21 Part 11 compliant and our bio analytical services ensure the highest quality standards in compliance with guidelines. All data is electronically transferred and documented and all studies are scrutinized by the QA Department and subjected to periodic in-house audits to ensure compliance.

Bioanalysis - A Value Proposition

Comprehensive list of assays
Quick turn-around times
Expertise in handling various matrices (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
Simultaneous analysis of parent and its metabolites
Methods for endogenous compounds at low detection levels
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 15 units of LCMS/MS -MDS Sciex which includes:

Sl No	Instrument	No. of instruments
1	AB Sciex 6500+	3
2	Waters Xevo TQS	2
3	AB Sciex 5500	4
4	AB Sciex 5000	2
5	AB Sciex 4000	6
6	AB Sciex 3200	3
7	AB Sciex 3000	1
8	Shimadzu 8060	2
9	ICPMS	1
	TOTAL	23 LCMS/MS + 1 ICP-MS

Our lab is equipped with , Ultra Water Purification system, spacious wet-labs for Biological Sample Extraction, positive & negative pressure manifolds, air handling units -fume-hoods and more. Separate Bioanalytical lab space for processing light sensitive molecules.

All study samples at Lotus Labs are stored in secure freezers at storage temperatures of - 20° C (-20 to -35° C )and -70° C (-60 to -80° C). These freezers are monitored round-the-clock with power backup and have a combined capacity to store close to 1 million samples.