Innovations in Bioanalytical Technologies for Biotherapeutics

Innovations in bioanalytical technologies have made it possible to engineer biological molecules for medical purposes during the past few decades. 

FREMONT, CA :  Bioanalytical studies are an essential aspect of biological drug development because data from these studies are required to define new biologic molecules' features. Besides, bioanalyses are vital; in directing the areas of disease treatment where such molecules can be effective. Bioanalyses data are also an essential inclusion in regulatory filings, which drives the demand for outsourcing partners who have in-depth experience developing the appropriate bioanalytical assays for a project and experience interacting with regulatory authorities.

Since even the smallest hurdle can significantly affect both function and immunogenicity, it is essential that biotherapeutics can be analyzed to the highest level of detail. Furthermore, the complex manufacturing operation for biotherapeutics offers even significant scope for structural deviation. It is therefore vital to ensure that only correctly formed and conjugated product reaches the supply chain. The requirement to gain in-depth structural and compositional knowledge of complex biopharmaceuticals has placed massive demands on bioanalytical potentials.

Indeed, it has catalyzed the development and improvement of numerous techniques for analyzing proteins and deciding immunogenicity.

The slightest structural alterations in a protein can have critical efficacy and safety concerns. Besides, there is the considerable ability for contamination with degradation products and unconjugated precursors, which could offer rise to adverse impacts. Such safety issues led to introducing regulatory needs for each component of a biotherapeutic to be isolated and individually characterized. The powerful separation potentials of ultra-high-performance liquid chromatography (UHPLC), coupled with its speed and good resolution, make it a vital tool for biopharmaceuticals characterization.

Biosimilars are similar to the biotherapeutic equivalent for small molecule drugs. The abbreviated licensure pathway for biosimilars allows new versions of a biotherapeutic on the market to be licensed if proven to be comparable. Since even the slight difference in post-translational modifications, like glycosylation, can considerably alter the function and immunogenicity, highly efficient analytical ways are required to confirm that a biosimilar closely replicates the originator molecule.

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