Challenges Of New Molecular Format Development

By Alice Harrison, Global Technical Director (CMC and Analytics), Lonza, and Nathalie Knabe, Head of Strategic Marketing, Mammalian, Lonza

The storied rise of monoclonal antibodies (mAbs) in the pharmaceutical industry ― full of challenges and triumphs ― offers a compelling case for what is possible when science and technology come together to address development and manufacturing bottlenecks. Now, as we see more manufacturers pursuing next-generation therapeutics, the history of mAbs and, more importantly, the need for fit-for-purpose solutions and technologies to bring new and innovative products to fruition is more applicable than ever. This is due, in part, to the increasing prevalence of new molecular formats, such as recombinant proteins and fusion proteins in today’s global biologics pipeline, a presence that is expected to grow at a rate two times faster than mAbs. These formats have the ability to be more precisely targeted and more potent, and potentially open up access to new therapeutic targets and biological mechanisms previously not accessible with mAbs. However, the operational and technical challenges of these molecules can complicate development and manufacturing, and lead to delays and added costs.

To make sure their existing solutions and strategies are able to accommodate the needs of customers and their therapies, Lonza recently conducted a survey to confirm the challenges in upstream, downstream, and analytical development of new molecular formats, as well as identify any additional challenges in developing biologics based on them. Download the full paper to find out where the industry stands today with these exciting products and what can be done to ensure they reach the patients who need them.