Phase Appropriate Analytical Method Development & Validation
Prepare your program for its next phase of development with our robust and adaptable analytical methods. Our team supports analytical method development and method validation across the entire development and commercialization timeline. We approach each project with clear considerations of your current progress and phase requirements to achieve a ‘fit for purpose’ method that maximizes efficiency and quality. Regardless of your starting point or sample type, we guide you through the process, drawing on our extensive experience with a diverse range of molecules, materials, formulations, and packaging configurations.
As methods are established, our team works with you to draft custom validation protocols, provide thorough reporting at the conclusion of method development, and deliver reports appropriate for regulatory submission once method validation is completed. We also support client-supplied protocols and comply with all ICH and FDA guidelines. Our protocols retain flexibility for customization as we collaborate to support a phased approach that coincides with your pharmaceutical product development timeline.
Phase-appropriate Support
Analytical method development is an ongoing component of your drug development program and evolves in tandem with your product. Our experienced team selects methods tailored to each stage of your program, ensuring efficient timelines, cost-effectiveness, and compliance with quality requirements.
Advanced methods provide the framework for executing excellent early-phase clinical research, particularly with impurity analysis. Early phase clinical research projects usually do not have extensive analytical data, and there are typically small, uncharacterized impurities. During this phase of development, it is not unusual to see large batch-to-batch changes in these impurity profiles. As a result, we run forced degradation studies to understand degradation profiles. Our team are experts at extracting, separating, and harvesting the new impurities with minimal changes to the method.
Method Development Services
Whether your project requires routine testing or specialized methods, we provide analytical method development support across all stages of drug development. Our integrated services also enable the seamless methods transfer to our certified cGMP facilities in later phases of development.
Analytical methods are varied and most need to be validated for successful drug development. Examples include:
- Stability-Indicating Assays / Impurity Profiles
- Drug Release / Dissolution / Elution Methods
- Residual Solvents Methods
- Elemental Impurities Methods
- Specific & Non-Specific Cleaning Verification / Validation Methods
- Drug Product Testing
We customize methods to suit the target compound and underlying purpose in order to provide relevant data for your drug development program.
Qualitative Tests:
- Accuracy (At Limit)
- Specificity
- Limit of Detection / Limit of Quantization
- Stability of Standard & Sample (When Appropriate)
Quantitative Assays:
- Instrument / Method Precision
- Accuracy
- Linearity / Range
- Specificity – Matrix Components
- Specificity – Forced Degradation Studies
- Method Robustness / Ruggedness
- Limit of Detection / Limit of Quantization
- Stability of Standard & Sample Solutions
- Intermediate Precision
We invest in state-of-the-art instruments, equipment, and facilities to ensure your program is supported by the most appropriate technology available.
- High-performance Liquid Chromatography (HPLC-UV, HPLC-MS, HPLC-MS/MS)
- Ultra-High-performance Liquid Chromatography (UPLC-UV, UPLC-MS)
- Gas Chromatography (GC-FID, GC-TCD, GC-MS)
- Ion Chromatography (IC)
- Inductively Coupled Plasma (ICP-MS, ICP-OES)
- Atomic Absorption Spectroscopy (AA)
- Solid State Characterization Techniques
Method Validation
Our team develops a standard operating procedure (SOP) to detail the method validation process based on the parameters, processes, and acceptance criteria that are applied. We draft custom validation protocols or follow protocols you provide to meet and comply with ICH and FDA guidelines. Our experience spans the spectrum of development, including Phase I, II, and III.