Analytical method development, qualification and validation

Analytical method development, qualification and validation
Product Description

BE BioSol provides phase-appropriate analytical support for biologics, vaccines and injectable drug products. Our capabilities include developing and optimizing methods for identity, purity, potency, concentration, product-related variants, impurities and microbiological quality. We also support stability-indicating methods, method transfer, compendial-method verification, qualification and validation. Analytical programs are designed to support process development, product characterization, release testing, stability studies, comparability assessments and regulatory submissions through clinical and commercial manufacturing.

BIOLOGICAL E. LTD

  • Country/Region:
    India
  • On CPHI since:
    2015
  • Employees:
    5000+
Company types
Manufacturer/Innovator
Specifications
  • Details
    BE BioSol provides phase-appropriate analytical support for biologics, vaccines and injectable drug products. Our capabilities include developing and optimizing methods for identity, purity, potency, concentration, product-related variants, impurities and microbiological quality. We also support stability-indicating methods, method transfer, compendial-method verification, qualification and validation. Analytical programs are designed to support process development, product characterization, release testing, stability studies, comparability assessments and regulatory submissions through clinical and commercial manufacturing.
  • Selling Points
    FDA, Approved, EMEA Approved
  • Supplied from
    India

BIOLOGICAL E. LTD

  • Country/Region:
    India
  • On CPHI since:
    2015
  • Employees:
    5000+
Company types
Manufacturer/Innovator

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