Pharmaceutical and healthcare products require detailed analysis — chemically, biochemically, and preclinical assessments — as part of the license submission package to assure quality, safety, and efficacy.
Woodley BioReg’s knowledge-based analytical development process uses a wide-range of techniques to gain information about a target molecule’s properties and to eliminate inappropriate or redundant methods.
The methods selected probe the known structure and properties of the product, e.g. stereochemistry, protein, lipid, carbohydrate, primary, secondary, tertiary, and if relevant quaternary structure, PTMs, etc.
Analytical testing is used in all aspects of drug and device development including raw material testing, in-process testing, release testing, stability testing, investigative testing, and post registration testing for drug substances and products. It forms an important part of the analytical development strategy for several reasons including:
- Analytical tests can be simple and cheap to perform
- Analytical methods are well understood and relatively easy to validate
- Analytical tests are relatively easy to specify and can be used throughout manufacture, release, and shelf life
- Analytical tests can be used to measure several parameters of a range of constituent components
Types of tests are :
Each test method — analytical or biochemical — must be appropriately validated against ICH requirements, under which methods are classed as assay, identity, or impurity tests. Each method requires a documented assessment on its accuracy, precision, repeatability, specificity, detection limit, quantitation limit, linearity, range defined in validation activities, validation protocols and reported in validation reports.
Regulatory agencies espouse the importance of a robust and well-documented analytical development strategy by their acceptance of biochemical bridging for post-marketing activities, such as comparability protocols and/or equivalence protocols in support of process changes and technology transfer activities.
The evolution and derivation of the selected test methods (and the omission of other methods) must be documented as part of the licence submission package both at clinical trials/IND application and at MAA stages. A detailed justification of the test specifications must be provided as part of any submission package justifying the inclusion and exclusion criteria for tests.
Need further information?
Woodley BioReg offers a wide range of analytical development support activities including:
- Development of analytical development and product characterisation strategies
- Development and preparation of SOPs and validation documentation,
- Preparation and submission of comparability protocols
- Preparation of license application submission components in eCTD format
WBR’s approach is knowledge-based and ensures regulatory acceptance through robust and detailed justification that is underpinned by data. Our approach has been widely applied and accepted for pharmaceutical and biological products.