Due to its toxicity it is vital to ensure removal to extremely low allowable limits.
We work with our clients to design and deliver bespoke and molecule specific strategic protein analytical programs, designed to optimise the data required to determine or confirm identity, explore patterns of heterogeneity and demonstrate consistency in quality of the drug substance or drug product such as proteins glyco-proteins, biosimilars, monoclonal antibodies, PEGylated proteins, antibody drug conjugates, bispecifics, and vaccines.
To support your submission, we can provide data to Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP), as appropriate, with comparison against the most suitable reference standard, if available.
With strengths in protein structure analysis, physiochemical property determination, biological and functional assays, product- and process-related impurity testing we can help you to achieve a "well characterized" protein drug substance or drug product.
Through experienced protein analysis we can support your product development, in-process testing, identity confirmation, comparability, stability testing and batch release testing.
Process equipment such as single use bioprocessing systems must be evaluated for their propensity to give rise to leachables which may migrate into the final product.
Both EU and US regulations clearly require that production equipment should not “present any hazards to the product” and should not be “reactive, additive or absorptive”.
You will require a good understanding of process residuals early on in development to attain a good understanding of your process and to establish acceptance criteria for ongoing testing requirements such as batch release testing.
These process-related impurities are typically present in trace levels in challenging sample matrices and so quantification can be challenging.
Peptide Mapping Intertek conduct selective fragmentation of protein into discrete peptides by enzyme or chemical digestion followed by high-performance liquid chromatography and electrospray mass spectrometry analysis and /or MALDI-TOF MS.