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.
To ensure their existing solutions and strategies can accommodate the needs of customers and their therapies, Lonza conducted a survey to confirm the challenges in upstream, downstream, and analytical development of new molecular formats and to identify any additional challenges in developing biologics based on them.
The global presence of next-generation therapies is expected to grow at a rate two times faster than standard antibodies, due to their ability to be more precisely targeted and more potent. Nevertheless, realizing their potential calls on appropriate expression technologies and development processes that can facilitate their path-to-market.
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 novel molecular formats into the clinic.
Explore the unique challenges of Fabs and Fc-fusion protein process development and manufacture and solutions to achieve an accelerated path to IND. Lonza shares their integrated drug substance and drug product CMC strategy and technical case studies that provide insight into how they have delivered tailored product-specific solutions.
Implementing process intensification can offer vital benefits 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.
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