by Andrew Brown, Eng.D.
Director, Global Process Development
Accelerating drug development and IND filing with integrated, streamlined, and collaborative DNA-to-IND solutions, helping our customers bring their innovative therapies to the clinic faster.
A faster path to the clinic: how an integrated and streamlined approach can help to accelerate drug development and IND filing for Biologics
For smaller startups and academic spinoffs bringing their first molecules to market, getting to the clinic is a major milestone. Shortening the time to investigational new drug (IND) filing can help to increase the value of their drug development programs.
Accelerated drug development expertise
For smaller startups and academic spinoffs bringing their first molecules to market, getting to the clinic is a major milestone. Shortening the time to investigational new drug (IND) filing can help to increase the value of their drug development programs.
We have been offering an accelerated drug development solution for monoclonal antibodies (mAbs) since 2021. This offering covers a range of development, manufacturing and testing activities – from the creation of expression vectors, to the clinical manufacturing of drug substance, and many other activities in between.
The ability to perform activities in an integrated manner enables Lonza to provide a service from DNA to IND (Figure 1) in a reduced timeframe.
Figure 1: Biologics development pathway, from bench to clinic
As the Manager of Global Process Development Support, I lead a team of experts at Lonza that have a deep understanding of the process science of upstream and downstream operations for the production of therapeutic proteins at all manufacturing scales.
Recently, I have been focused on working with a cross-functional team of SMEs to develop similar integrated offerings for the wide range of other antibody-based and protein modalities that many biopharma companies are developing today.
Within Lonza, I have been fortunate to learn first-hand from teams across the global network who have delivered drug development and manufacturing activities that enable these molecules to enter the clinic on an accelerated timeline. I have also worked with many different expression systems and generated the data needed to support successful IND filings. I actively use that experience to find better solutions for Lonza’s customers.
A tailored process for IND filings
Molecular diversity presents a challenge to drug development and manufacturing activities, as platform approaches may not be suitable. This creates the need for a tailored approach to address product-specific requirements.
The first task of the cross-functional team was to establish categories to cover the range of modalities (Figure 2), so as to enable tailored offerings to be developed. The four categories selected were:
Figure 2: Examples of molecular modalities Lonza has experience in
We took a deep dive into the development pathways for these molecules. Through many collaborative workshop meetings, we spent time understanding where the interdependencies lie across drug development, manufacturing and testing activities.
This included identifying where information is generated that is required for decision-making in other functional areas. This work led to the identification of a project delivery critical path for each offering.
Reducing DNA-to-IND timelines
Effort was then directed towards optimizing the critical pathways and understanding the basis and assumptions that underpin the approaches. The teams extensive experience with these different types of modalities, coupled with deep process and analytical know-how, was used to determine which operations could be performed in parallel, and to inform the development of highly robust upstream and downstream processes.
Previous timelines for these more complex molecules of 22 to 24 months to go from DNA to IND filing. This timeline has now been reduced for some types of bispecifics to 13 months (Figure 3); this represents a significant time saving.
Figure 3: Key stages of DNA to IND timeline for bispecific antibodies
A collaborative approach for faster, integrated drug development solutions for our customers
I have now spent five years working at Lonza. During this time I have benefited from opportunities to work across functions. I have learnt about the capabilities of each site and team across the global network, and to work alongside tremendous talented and skilled experts.
I initially viewed this opportunity as predominantly a technical challenge, but realized through the journey that bringing new offerings to customers requires close collaboration and open communication across teams that are aligned to the same goal.
I have enjoyed working on the development of integrated offerings that support the needs of our customers and helping them find opportunities to speed up timelines while maintaining confidence in the manufacture of high-quality products, suitable for use in clinical trials.
Seeing the impact of these integrated offerings and my conviction that it will benefit patients fills me with pride. Talking to existing and potential customers about the integrated offerings and why we took the approach we did, has been enjoyable and insightful, and has helped to verify and challenge our approach.
The integrated offerings we have built across modalities represent our current interpretation of the best approach, based on Lonza’s knowledge and know-how. Not all offerings are able to benefit from these approaches yet, but we do hope to be able to change this by continuing to learn from how our process and analytical tools work with the molecules and to work with our customers.
We are excited to take their feedback and find opportunities to further improve, so that we can drive impactful solutions in the future.
About the author:
Andrew Brown, Eng.D., Global Process Development, Lonza. Andrew is a Biochemical Engineer with over 15 years supporting the CMC development of biologic therapies of different modalities ranging from bispecifics, mAbs, recombinant proteins, bioconjugates and gene therapy viral vectors. At Lonza, he leads a team of subject matter experts in upstream and downstream processing of biologics, who support Lonza’s global network of development and GMP manufacturing sites in the delivery of pre-clinical and clinical CMC activities.