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Method Development and Validation – Large Molecule Formulations

ICH Q2(R1) is considered the primary reference for recommendations and definitions on validation characteristics for analytical procedures.

One of the most significant challenges of working with large molecules stems from the fact that, unlike small molecule APIs or finished products, which due to their nature form neat solutions, they are mostly endogenous compounds derived or manufactured from biological systems. Successfully validated analytical methods will be continuously used during the lifecycle of the product, therefore it is important that any method development is undertaken with consideration of the product lifecycle in mind.

At Tepnel, we develop and validate methods designed to provide the appropriate information applicable to your specific phase of development. We understand that as your biopharmaceutical progresses from discovery, through stability and onto final product release testing, different levels of method validation will be required.

We work with you to anticipate and understand the life cycle changes required in your analytics and in partnership will seek to determine what is applicable to the phase and products intended use to gather and document the right data.

Large molecule analytical techniques available for method development and validation at Tepnel include:


Structural Elucidation and CharacterisationChromatography based Techniques
Fourier transform infrared spectroscopy


Reverse phase high performance liquid chromatography (RP-HPLC)

Ultra performance liquid chromatography (UPLC)

Size exclusion chromatography (SEC-HPLC)

Ion exchange chromatography (IEC)

Gel permeation chromatography (GPC)

Peptide mapping


Ion chromatography

Gas chromatography

Electrophoretic TechniquesMicrobiology
Sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE)

Isoelectric focusing (IEF)

Capillary zone electrophoresis (CZE)

Bacterial endotoxins


Sterility testing



Our scientists are experienced in developing and validating various types of ELISA to support large molecule product licensing and commercial release. We have developed and validated a large number of ELISA assays, in both direct binding or competitive format to characterise recombinant protein/monoclonal antibodies.

Sections in Method Development and Validation

All Method Development and Validation

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