Method Development, Validation and Transfer

Method Development, Validation and Transfer
Product Description

Kymos Pharma Services, S.L. offers wide range of chemistry, manufacturing & control analytical services in medicinal chemistry which includes method development, validation and transfer. Kymos has comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary methods for excipients, apis, intermediate products and finished products, according to the ich q2 (r1) and fda guidelines and using qbd strategies to improve the results. Their methods are ready for transfer to contract-giver, in compliance with eu-gmp chapter 6, performing a comparative test, a co-validation in two sites or a revalidation. Contact us for more information.

Kymos Pharma Services, S.L.

  • ES
  • 2016
    On CPhI since
  • 4
    Certificates
  • 100 - 249
    Employees
Contract Service
Specifications
  • Selling Points
    Product Features; Quality Service
  • Supplied from
    Spain

Kymos Pharma Services, S.L.

  • ES
  • 2016
    On CPhI since
  • 4
    Certificates
  • 100 - 249
    Employees
Contract Service

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    Product Bioanalysis of Small Molecules

    Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes bioanalysis of small molecules. Kymos offer bioanalytical method development and validation of innovative small molecules by mass spectrometry. It has the experience of being the selected partner for different companies for the development of proprietary methods from the start-up of a project to the market. Features - research: in vitro and in vivo admet studies, early development: preliminar pharmacokinetics, regulatory preclinical in different species: toxicokinetics, phramacokinetics, pharmacodynamics, phase i studies: parmacokinetics, dose searching studies, single and repeated dose, phase ii to iv clinical studies: related biomarkers, interaction with concomitant medication and feed. Contact us for more information.
  • Immunogenicity

    Product Immunogenicity

    Kymos Pharma Services, S.L. offers wide range of bionalysis services in medicinal chemistry which includes immunogenicity. Kymos have develops new bioanalytical methods for immunogenicity studies of proteins and peptides following ema and fda guidelines on immunogenicity of therapeutic proteins. Depending on the purpose and the stage of the research project, different studies should be performed: determination of binding antibodies: screening, confirmatory and titration, neutralizing antibodies, antibody typology, cellular immune response. Contact us for more information.

Kymos Pharma Services, S.L. resources

  • News Kymos Acquires Germany’s Prolytic

    Kymos, a Contract Research Organisation (CRO) and member of CataloniaBio & HealthTech, has bought German company Prolytic GmbH in order to strengthen its activity in the biologics and advanced therapies market. The company previously acquired Italian firm Pharmaprogress in 2016.

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