Method & Assay Development
- Delivering a comprehensive set of custom-made, orthogonal methods for
- product purity & product-related species
- impurities (product-related, process-related & host cell derived)
- Providing robust tools with the specificity, sensitivity, accuracy & precision required for you to track critical quality attributes (CQAs).
- Covering each critical aspect of your method through method performance verification, including:
- sample preparation
- LOD/ LOQ
- critical reagents
- range determination
- Proving a comprehensive method development report & final method with acceptance criteria in line with the intended purpose.
- Transferring your identity, purity, quantity, potency & general quality methods for your drug substance & drug product into a controlled, GMP-compliant environment.
- Supporting phase specific validation throughout all phases of development (Phase I - III) & commercialization (Phase IV).
- Covering all ICH validation parameters, according to Q2(R1) such as specificity, linearity, LOQ/LOD, range determination, accuracy, precision & robustness.
- Take into consideration:
- critical reagents handling & bridging approaches.
- establishment of reference & reference standard handling including storage.
- Providing a comprehensive validation protocol, report & validated method.
Accelerated Stability Studies
- Covering a comprehensive package of in-house methods and software supported design of experiments (DOE) approaches allowing cost effective screening within a short turn around time (TAT).
- Stressed formulation studies to define your optimal molecule stability conditions for further development.
- Excipient compatibility testing in liquid and solid environments.
- Quick & accurate determination of product shelf-life through ASAPprime® software.
- Protocol development and full data interpretation.
- Assessing comparability during the complete product development journey in case of manufacturing changes using in-house or product specific methods.
- Providing analytical evidence that your product has highly similar CQAs before and after the manufacturing change in accordance to ICH Q5E.
- Defining the degradation pathway of your drug substance & product.
- Assessing & validating the stability indicating power of your methods will require the subjection of your molecule to extreme stress conditions
Relevant stress conditions are:
- Heat (Temperature)
- Hydrolysis (acid/base)
- Freeze/Thaw cycling
- Target % of degradation will depend on your molecule & the method capabilities.
- Providing an in-house comprehensive analytical package to. Support your GMP & non-GMP release for your drug substance & drug product throughout all phases of development (Pre-clinical, Phase I-III) & commercialization (Phase IV).
- Advice for specification settings based on guidelines, historical results and analytical methods capabilities.
- Certificates of analysis (CoA) conform GMP standards.
- Supporting your stability studies for your drug substance & drug product throughout all phases of development (Phase I-III) & commercialization (Phase IV), according to in-house or custom-made procedures & protocols, compliant with regulatory requirements.
- Developing stability protocols conform ICH guidelines.
- Accelerated and ASAP stability studies including protocols and data interpretation.
- Offering a GMP-compliant & FDA inspected facility, full traceability by means of our LIMS labware system (from intake, throughout storage according to ICH conditions, to final analysis & reporting), dedicated quality assurance department, cross-functionality trained project teams for maximum project flexibility, and in-house engineering department to support our equipment around the clock.
Reference standard management / Trending
- Reference stock management using GMP (LIMS).
- Monitor quantity real-time.
- Periodical requalification according reference standards management program.
- Trending of acquired stability data using statistical software JMP.
- Lifecycle management of analytical methods by continuous method performance monitoring.
- Monitor analytical procedure variability using control charts and statistical software tools (JMP).
- Transferring your methods to a GMP-compliant laboratory environment via:
- comparative testing
- complete or partial method revalidation
- transfer waiver
- Based on a profound risk assessment, an implementation strategy is selected to match the complexity and specifications of the product and the corresponding procedure.
- Providing a comprehensive and well-designed transfer protocol upon mutual agreement of the strategy to be followed.
- Finalizing the transfer with a full-written transfer report with scientific interpretation of the data obtained in regard to the acceptance criteria.
- Offering a full package upon transfer, from release to stability storage under full ICH conditions.