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Pharmaceuticals and Biopharmaceuticals 

In Silico Drug Manufacturing and Delivery

Pharmaceutical and biopharmaceutical leaders are leveraging the power of in silico approaches to address the unsustainable cost and time required to develop drug manufacturing, production scale up and drug delivery processes. 

Digitally Transforming Drug Manufacturing and Drug Delivery

Traditional drug manufacturing and drug delivery process development requires a huge time and financial investment. To accelerate innovation and dramatically reduce costs and time to market, in silico approaches are the only viable solution. Applying engineering simulation and mechanistic modeling to identify the best delivery route or to scale up production equipment from lab scale to mass production is crucial  to achieve regulatory approval on a sustainable timescale and budget.

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    Drug Manufacturing
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    Clean Rooms and HVAC
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    Drug Delivery
Drug Manufacturing

Simulation Lowers Costs While Delivering Better, Safer Processes

Pharma Simulation

Drug manufacturing benefits from streamlined scale-up processes that cut time and costs

Engineering simulation streamlines process scale-up and optimizes upstream and downstream operations, cutting development time and operating costs by an order of magnitude.

Optimizing air flow patterns is critical for clean rooms to comply with safety regulations

Modeling the complex airflow patterns resulting from variable configurations and operations of HVAC systems ensures a sterile clean room environment with optimized operational costs.

Drug delivery is made safer and more effective through population testing simulation

In silico methods that leverage large-scale variation through virtual patients are crucial to optimizing the drug delivery process, accounting for population variations and ensuring broadly applicable results.

Applications

In silico methods are pervasive across drug manufacturing and delivery, offering major reductions in cost and time to market for each component of equipment and devices across all pharmaceutical sectors. Process engineers use modeling and simulation for equipment optimization and scale-up of upstream processes such as bioreactors and mixing tanks and downstream processes, including chromatography, filtration and lyophilization.

In drug delivery, modeling and simulation are used for inhaler and respiratory drug delivery, drug eluting stents, syringes, auto-injectors, and other injection processes.

Disruption in Healthcare is Here: Are You Ready?

In silico medicine promises to radically remake healthcare while increasing innovation and reducing costs.

personalized healthcare

Simulation in healthcare can deliver ROI of more than 500%.

Access to good healthcare should be an elementary right for any human being. However, establishing and maintaining this right is proving to be a significant challenge for some economies.

Delivering high-quality healthcare to a heterogeneous, worldwide population is a challenging proposition. Healthcare spending is rising rapidly, and regulations for product safety are more stringent than ever. As world population grows, developing the right medicines and making them accessible will become an ever more difficult task.

Drug development and delivery under traditional models cannot meet the rising demand for rapid prototyping without incurring unsustainable costs for manufacturers. Simulation promises to massively disrupt the healthcare sector by allowing rapid prototyping and fast, broad testing to meet regulation requirements. By limiting production and real-world testing to the strictly necessary, engineering simulation makes it possible to develop new drugs on a realistic budget, yielding safe, useful medicines for the world and big returns for companies that take initiative.

Radical New Approaches to Pharma

To accelerate the deployment of simulation-based solutions to the clinical community, the leading medical device and pharma companies, in collaboration with the regulatory and the simulation industry, have developed best practices that can dramatically reduce cost and time to market while maximizing patient safety.

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Virtual human lab

The ‘Virtual Human Laboratory’ allows faster insight with physiological models.

Creating and validating virtual anatomical models or predicting the behavior of drugs and manufacturing equipment enables companies to quickly gain insight regarding a new product or process.

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Digital twins will create ‘Personal Digital Avatars’ to unlock new avenues of personalized medicine.

The future is calling for predictive and preventive medicine driven by personal digital twins that are fed by smart connected devices.

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‘Simulation-Driven Regulatory Approval’ opens the door to digital evidence.

As regulatory agencies are opening the door to digital evidence, it is crucial to create verified and validated (V&V) models of sufficient credibility to address regulator questions/concerns. 

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