The production of large molecule drugs — such as peptides and monoclonal antibodies — have to meet stringent quality standards in order to ensure their efficacy and safety. To achieve this, both product development and process manufacturing workflows need to be well-designed, tightly controlled, and most importantly, aligned in all handover processes. This is especially important during ‘fill and finish’ (F&F) operations since it’s the last step before the drug is administered to patients.
Given the complexity and inherent instability of most proteins, F&F operations must be designed keeping in mind the environmental factors that can affect their behavior and stability. This raises several challenges for innovation within the biopharmaceutical industry, regarding specialized equipment and processes that ensure the integrity of protein products. On top of this, the move to continuous, fully automated workflows that meet Pharma 4.0 standards is always a consideration.
In this on-demand webinar, Dr. Marcel Tigges from Janssen discusses some of the production challenges faced by researchers working on large molecule process development and how Janssen has optimized their production workflows during F&F by implementing new technologies such as nanoDSF. Additionally, Dr. Silvia Würtenberger explains why Prometheus is the new gold standard that precisely characterizes protein stability.
From watching this on-demand webinar you will:
- Gain an understanding of the production challenges faced by researchers working on large molecule processes and their need for low volume, high-throughput, and real-time analysis technologies to address these issues.
- Understand how the implementation of new technologies for monitoring protein conformational stability (nanoDSF), protein concentration (PAT-FlowVPE) and computational modeling (CFD), are optimizing the monitoring of critical quality attributes (CQAs) and critical process parameters (CPPs) at Janssen and help preparing for Pharma 4.0.
- Learn why leading researchers choose Prometheus — the new gold standard that precisely characterizes protein stability.
- See how conformational stability testing with Prometheus has allowed Janssen to optimize both formulation and process parameters to ensure the highest quality of their products and move one step closer to implementing Pharma 4.0 standards in their workflows.