AnaBioTec is an independent Belgian-based analytical service provider focusing on Small molecules; Biologics; Biosimilars; Cell & Gene Therapy solutions.
With more than 20 years of experience, we drive your business forward by intensive collaboration between our experts & yours. We understand how in-depth product knowledge & drug development expertise are critical attributes for success.
Our early development department fits seamlessly to our well established GMP compliant platform offering analytical support in all phases of your drug development.
With AnaBioTec you have the right analytics available at the right time!
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- Method & Assay Development
- Method Qualification
- Method validation
- Accelerated Stability Studies
- Forced degradation
- Reference standard management / Trending
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.