The Benefits Of Mass Spectrometry For Expediting Biologics To Patients

The presence of novel and increasingly complex molecules in today’s pipelines requires analytical methods with higher resolution, throughput and sensitivity. Development of multi-specific antibodies (msAbs), fusion proteins and new molecular entities (NME) places a greater need on using these approaches, even at early stages of process and product development. This is due, in part, to a lack of available platform processes that have been the bedrock of accelerated monoclonal antibody development timelines for both gene to investigational new drug (IND) application and IND to biologics license application (BLA). Development paths have been reported to be further accelerated in response to the COVID-19 pandemic, with the potential to reduce gene to IND timelines to only six months. The path from IND to BLA for new molecular formats is a far greater challenge, without the years of platform process understanding and the increased number of product quality attributes.

With an increased number of products on accelerated regulatory approval pathways, there is increased pressure on CMC development to support shortened BLA submission timelines. This is the point at which mass spectrometry (MS) can be leveraged to accelerate and de-risk product and process development. Download the full article to learn how applying advanced MS methods can offer the potential to accelerate product development by shortening process characterization timelines.