Best Practices in Bioassay Development to Support Registration of Biopharmaceuticals

Abstract

Biological activity is a critical quality attribute for biopharmaceuticals, which is accurately measured using an appropriate relative potency bioassay. Developing a bioassay is a complex, rigorous undertaking that needs to address several challenges including modelling all of the mechanisms of action associated with the biotherapeutic. Bioassay development is also an exciting and fast evolving field, not only from a scientific, medical and technological point of view, but also in terms of statistical approaches and regulatory expectations. This has led to an industry-wide discussion on the most appropriate ways to develop, validate and control the bioassays throughout the drug lifecycle.

Utility of fatty acid profile and in vitro immune cell activation for chemical and biological standardization of Arthrospira/Limnospira

“…Selecting an appropriate in vitro bioassay for biological standardization is driven based on the product’s mechanism of action 27 . The Limnospira -derived lipoproteins, similar to other Braun-type lipoproteins, are activators of TLR2 signaling.…”

Integrated and automated high-throughput purification of libraries on microscale

“…While the hygroscopic nature of DMSO results in adsorption of water and consequently a reduction in the concentration of the drug candidates these deviations are significantly lower than the error margins found for typical biochemical assays. [47] Furthermore, the increased accuracy provided by the CAD-based quantitation over gravimetric solution preparation with respect to salt form and residual solvents helps to negate errors resulting from water absorption. In order to further reduce water absorption, the DMSO used in the Mantis liquid dispenser is stored in a capped bottle over molecular sieves and is changed at regular intervals.…”

The Essentials of Marine Biotechnology

“…It is typically done using in vitro, ex vivo or in vivo approaches. The bioassayguided identification and purification of novel compounds is a common practice (Strömstedt et al, 2014;White et al, 2019). First, the selection of the extraction protocol may affect the possibility of testing for biological activity, as not all solvents that are used for extractions are biocompatible.…”