Method Development and Validation
Whether you need expert testing consultation, method development or validation protocol design, Eurofins BioPharma Product Testing network of laboratories 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.
Why Choose Eurofins BioPharma Product Testing?
- We collaborate with you by thoroughly understanding your testing requirements, designing a project approach to achieve your end goals, developing methods in the most efficient manner to maximize your research budget and validating or transferring the method for its intended use.
- We offer phase appropriate method validation. All work is performed under full cGMP compliance.
- We have the most experienced staff, performing more than 600 validation, qualification, verification and transfer protocols for our customers per year.
- We place an emphasis on building relationships and rapport with our clients.
- Our Method Development and Validation Teams works hand-in-hand with the receiving lab to ensure a seamless transfer of methods.
- We assure timely delivery of services by establishing a project schedule and monitoring progress through weekly conference calls when useful.
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, as well as referencing the Analytical Quality by Design approach. We evaluate attributes which may include 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 such as improving chromatographic resolution of a principal peak 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 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.
- Early Phase Validation - Performed on methods supporting early phase product. Performed to ensure method is appropriate for its intended use. Phase appropriate validation 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 Ph. Eur./USP general chapter and the ICH guidelines. Validation is performed under the direction of a protocol.
- Method Verification/Suitability - Performed on compendial methods to ensure that the methods perform acceptably on your compendial API or product matrix. Verification is performed under the direction of a protocol.
Method Development and Validation Suitability for:
Chemistry/Biochemistry
- Assay/Potency, Purity/Impurity, Dissolution
- Cleaning Validation Analysis (Specific and Non-specific analyses)
- Assay, Impurity and Dissolution methods for Comparator products
- Residual/Impurities Testing
- Leachables
- Excipients
Microbiology
- Bacteriostasis/Fungistasis for Sterility
- Inhibition/Enhancement Screening for Endotoxin
- AET and Microbial Limit
- Mycoplasma Testing
- Antibiotics Microbial Assays
Molecular and Cell Biology
- Cell-based Assays
- ELISA
- qPCR
Protocol Writing for
- Method Validation/Verification
- Method Transfer
