Challenges of New Molecular Format Development

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. 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. The results, as outlined in this paper, highlight where the industry stands today with these exciting products and offer valuable insight into what can be done to ensure they reach the patients who need them.

Additional Author: by Nathalie Knabe, Head of Strategic Marketing, Mammalian