Large Molecules Regulated Bioanalysis

Large Molecules Regulated Bioanalysis
Product Description

Lambda provides regulated bioanalytical support for large molecules, biologics and biosimilars across clinical development. Capabilities include large-molecule PK analysis, anti-drug antibody assessment, neutralizing antibody testing, pharmacodynamic biomarkers, functional bioassays, immunogenicity assessment and analytical characterization. The platform supports biologics development through integrated analytical capabilities, including in vitro cell-based bioassays, analytical tools for PK and immunogenicity, high-resolution mass spectrometry, analytical method development and validation, and microbiological testing. These capabilities support characterization and clinical development of complex biological products.

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Lambda Therapeutic Research Ltd

  • Country/Region:
    India
  • Founded:
    1999
  • On CPHI since:
    2015
  • Certificates:
    2
  • Employees:
    1000 - 4999
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Primary activities
Analytical Services
Clinical Research
Contract Research Organisation
Laboratory Services
Nutraceuticals
Regulatory Affairs
View company profile
Categories
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Specifications
  • Selling Points
    Large-molecule bioanalysis is integrated with Lambda’s biologics and biosimilars development capabilities, providing access to analytical and clinical development expertise within one organization. The platform supports PK, ADA, NAb, PD, biomarker and functional bioanalysis, complemented by high-resolution mass spectrometry and cell-based assays. More than 1,600 validated bioanalytical assays, 3M+ sample storage capacity, 60+ deep freezers and 12 high-sensitivity LC-MS/MS platforms provide the laboratory infrastructure for regulated bioanalytical programs. The bioanalytical platform includes 1,600+ validated assays, 12 high-sensitivity LC-MS/MS systems, controlled sample storage with capacity for more than 3 million samples, 60+ deep freezers, automated sample inventory management, and capacity to analyze more than 110,000 samples per month. 
  • Supplied from
    India
More specifications Fewer specifications

Lambda Therapeutic Research Ltd

  • Country/Region:
    India
  • Founded:
    1999
  • On CPHI since:
    2015
  • Certificates:
    2
  • Employees:
    1000 - 4999
Company types
CMO/CDMO
Contract Research Organisation (CRO)
Primary activities
Analytical Services
Clinical Research
Contract Research Organisation
Laboratory Services
Nutraceuticals
Regulatory Affairs
View company profile

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