Method Development and Validation

Whether you need expert testing consultation, method development or validation protocol design, Eurofins Sinensis offers you the widest range of laboratory techniques in the industry. We support customers at various stages of the development / validation process and have a proven track record of success on full development and validation studies, optimization of existing research methods and transfer of previously validated methods. 

Services

  • Method Development
    Prior to starting any project, we will discuss the project requirements with the client to ensure an appropriate scope is defined. We utilize our knowledge of method development on hundreds of products to assist with the development process. We evaluate attributes such as precision, linearity, accuracy and specificity during development to ensure the method is suitable for validation.

  • Method Optimization
    Methods may be optimized for a variety of reasons, including improving separation of a critical peak pair, or supporting a formulation change. In addition, methods not validated to current industry standards may require optimization to allow for successful validation.
     
  • Method Feasibility
    When methods are submitted for qualification or validation, we recommend performing feasibility prior to proceeding. Feasibility allows us to gain familiarity with the method and evaluate the method for attributes such as precision, linearity, accuracy and specificity with the hopes of avoiding protocol acceptance criteria failures.  
     
  • Method Qualification
    Performed on methods supporting early phase product. Performed to ensure method is appropriate for its intended use. Qualification may or may not be performed under the direction of the protocol.
     
  • Method Validation
    Performed on methods supporting later phase product. Methods are validated consistent with the USP general chapter and the ICH guidelines. Validation is performed under the direction of a protocol.  
     
  • Method Verification 
    Performed on compendial methods to ensure that the methods perform acceptably on your API or product matrix. Verification is performed under the direction of a protocol. 
     

Method Development and Validation Services For:
 

Chemistry/Biochemistry

  • Assay/Potency, Purity/Impurity, Dissolution
  • Cleaning Validation Analysis (Specific and Nonspecific analyses)
  • Assay, Impurity and Dissolution methods for Comparator products
  • Residual/Impurities Testing
  • Excipients
     

Microbiology

  • Bacteriostatis/Fungistatis for Sterility
  • Inhibition/Enhancement Screening for Endotoxin
  • AET and Microbial Limit
     

Molecular and Cell Biology

  • Cell-based Assays • ELISA
  • qPCR
     

Protocol Writing for

 

  • Single-point-of-contact. Eurofins Sinensis has all expertises within the same organization, allowing clear and reliable communication.
  • All services available internally. As Eurofins Sinensis is the mother holding of several complementary companies, all this expertise is brought together in one multidisciplinal organization.
  • Standard and custom services. Whenever necessary, additional services like pure culturing and/or testing of more, other genes can be provided. Please contact us if you want to discuss your needs.

Questions? Call us now

+31 (0)71 524 4080