Virtual twins and advanced simulation are changing the face of process engineering in Life Sciences. This technology has allowed us to simulate complex processes to predict outcomes with greater accuracy; improving our understanding and control of these processes, while saving time, resources, and reducing costs.
Process Engineering Challenges Faced by Biopharmaceutical Companies Today
Process enginnering is the design, development, optimization, and control of manufacturing processes to produce drug products and therapies efficiently and effectively. But, doing this successfully is not easy and comes with a myriad of challenges.
Challenges Include
Complex and dynamic processes
Managing the complexity and ensuring process stability pose significant challenges.
Regulatory compliance
In the highly regulated environment process engineering must align with stringent regulations.
Product quality and safety
Maintaining product integrity throughout the manufacturing process is not easy.
Scale-up and tech transfer
Scaling up processes from laboratory to full commercial production can be difficult.
Time-to-market
Streamlining processes, reducing development and manufacturing timelines, and optimizing efficiency are critical.
Cost management
Finding the right balance between cost reduction and process improvements is a constant challenge.
Addressing these challenges requires a multidisciplinary approach, involving collaboration between scientists, engineers, regulatory experts, and quality professionals. Biopharma companies need to invest in process engineering expertise, advanced technologies, and continuous improvement initiatives to overcome these challenges and stay competitive in the evolving industry landscape.
The Solution to Address Process Engineering Challenges
Line Process Engineering enables the development of all functional systems in the biopharmaceutical plant. With the solution you can define, simulate and validate the behavior of complex multi-physics process and ensure engineering integrity through a system engineering and model based design approach with one collaborative single source of truth.
Simulate the associativity between requirements and the design at all stages of the design process to detect incorrect, missing or conflicting requirements and perfectly engineer drug substance ad drug product processes. Furthermore, Line Process Engineering supports continuous improvement activities by performing process analysis and tests to validate process changes or the integration of a new process before it even exists.
The Benefits
8% Yield increase
10% CAPEX reduction
20% Process development cost reduction
50% Training time reduction
30% Reduction in tech transfer time