Newsletter | June 6, 2023

06.06.23 -- Leverage An Integrated Drug Substance And Drug Product CMC Strategy

Challenges Of New Molecular Format Development

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.

CMC Solutions To Meet Product-Specific Needs Of Novel Formats

Lonza has introduced integrated offerings intended to reduce the development timeline and improve overall productivity. Learn how an integrated drug substance and drug product CMC strategy for recombinant proteins can help deliver tailored product-specific solutions and enable the acceleration of this type of novel molecular formats into the clinic.

An Inside Look At CMC Strategy Development For Novel Biologic Formats

Andrew Brown, head of global process development support at Lonza, answers questions about an integrated drug substance and drug product CMC strategy for novel molecular formats and other recombinant proteins. Brown also reviews technical case studies that demonstrate tailored, product-specific solutions that enable acceleration into the clinic.

Process Intensification To Improve Efficiency, Productivity

Implementing process intensification can offer vital benefits such as reduced manufacturing costs and increased titers while maintaining product quality. Explore the key principles of process intensification as a strategy for improving the efficiency and productivity of biologics manufacturing, including process modeling, control, and advanced analytics.

The Benefits Of Mass Spectrometry For Expediting Biologics To Patients

With an increased number of products on accelerated regulatory approval pathways, this puts 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.

Navigating The 'Now What' After Early-Phase Success

Today’s evolving market calls on a flexible operations strategy that can accommodate changing volume needs throughout drug development. Therefore, while moving from early-phase to late-phase clinical trials is a critical milestone to celebrate on the way to commercialization, many face the same daunting question once the confetti settles ― now what?