Bioanalytical Services

Since inception, 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 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. Lotus Labs houses a fully centralized bio analytical facility at Bangalore with state-of-the-art laboratories managed by highly skilled and experienced scientific professionals which meets the applicable GCP requirements. Our capabilities in bio analytical services has ensured the development of over 500 validated bio analytical methods with the wherewithal to analyze over 40000 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 (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
  • 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:

  • Waters Xevo - TQC ( With UPLC ) - 2
  • API 5500 - 4
  • API 4000 - 6
  • API 5000 - 2
  • API 3200 - 3
  • API 3000 - 6

Our lab is equipped with 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. Separate Bioanalytical lab space for processing light sensitive molecules.

All study samples at Lotus Labs are stored in secure freezers at storage temperatures of at - 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.

Bioanalytical Services Portfolio

The bio analytical 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