Large Molecule Formulations

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.