Pharmaceutical digital thread
Pharmaceutical process development and tech transfer
Accelerate recipe development and foster collaboration using digital technologies, enhance drug manufacturability and efficiently scale up from lab to production.
Accelerate pharma process development and tech transfer
As the costs of developing a new therapy can stretch into billions of dollars, how can pharmaceutical companies leverage the digital technologies in the lab to accelerate the path to production?
Optimize your pharmaceutical process development
Reduction in time-to-market
Reduce time-to-market by half for some market segments. (Novonesis)
Decrease in raw material consumption
Minimize environmental impact by reducing raw material consumption by 30%. (Johnson & Johnson)
Collect data in real-time with the digital twin
Test and gain insights on all stages of the development processes in a virtual environment using the digital twin. (GSK)
Adopt proven preclinical development solutions
How can you rapidly design a robust pharmaceutical manufacturing process and enable faster, more efficient scale-up from lab to production? Explore these three key paths to learn more.
Optimize drug product formulations and design robust manufacturing processes.
- Coordinate project teams and deliverables across drug development phases and minimize time and effort spent on tracking and reporting
- Analyze complex decision spaces, confidently specify your product and process definitions, capture scientific knowledge and share insights
- Optimize your product and process design while minimizing physical experimentation, and adhere to Quality by Design principles
Promote greater efficiency in sharing and capitalizing on process knowledge.
- Efficiently manage product and process design specifications across the drug lifecycle
- Transform your recipe from lab to commercial manufacturing by leveraging the Enterprise Recipe Management (ERM) approach
- Keep track of regulatory data by facilitating collaboration across R&D, regulatory bodies, and external partners
Prepare and secure the path to production with manufacturability verification and optimization.
- Select the right production facility and seamlessly transfer your recipe to the shop floor
- Increase robustness, efficiency and sustainability of your commercial manufacturing
- Design, simulate, visualize, analyze and optimize production and logistics processes
GSK
Stepping up the pace in vaccine development
Company:GSK
Industry:Medical Devices & Pharmaceuticals
Siemens Software:Simcenter STAR-CCM+, TIA Portal, SIMATIC SIPAT , Industrial AI
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Transform your lab and accelerate the path to production while maintaining quality, sustainability and regulatory compliance.
Pharma process development and tech transfer solutions
Product & process design and Design of Experiments
Process design with a digital twin
Simulation-based performance engineering
Manufacturing process planning
Frequently asked questions
What is pharmaceutical process development?
Pharmaceutical drug product process development aims to optimize product and process design. It includes the process control strategy, while minimizing physical experimentation and adhering to Quality by Design principles. The pharmaceutical process development stage is supported by a digital twin of the drug product and manufacturing processes to identify inefficiencies, avoid costly mistakes and mitigate risks associated with scale-up.
How can my pharmaceutical company improve knowledge management?
To improve knowledge management, pharmaceutical companies must preserve and deploy process knowledge across the organization, transform the recipe from lab to commercial manufacturing by leveraging the Enterprise Recipe Management (ERM) approach and document evidence to prepare regulatory submissions.
Solutions like Riffyn X streamline data integration, improve data integrity, and facilitate efficient knowledge sharing across the organization. The platform supports versioned, shared processes, eliminating silos and enhancing collaboration. It adheres to findable, accessible, interoperative, reusable (FAIR) principles, structuring data for easy search and reuse.
How does a recipe management system benefit the pharmaceutical industry?
A recipe management system benefits the pharmaceutical industry by helping companies move away from the traditional siloed approach to a collaborative knowledge-driven approach that enables traceability and reuse of data across the drug lifecycle. Solutions like Teamcenter Easy Plan allow for efficient collaboration with internal and external parties on recipe definitions to accelerate regulatory-compliant clinical trials and commercial production.
How to optimize the scale-up process in pharmaceutical manufacturing?
To optimize the scale-up process, pharmaceutical companies can use science-based models and a digital process twin to predict product quality attributes and process behavior in pilot or commercial-scale equipment using data harvested from the lab scale. Solutions like gPROMS and Simcenter enable pharma manufacturers to integrate the virtual and real worlds seamlessly, eliminating discrepancies between process development and manufacturing domains.
What is tech transfer in pharma?
Tech transfer in pharma is the process of transferring knowledge and technology from the process development lab to clinical trials pilot facilities and onto commercial manufacturing. The primary goal is to ensure the robustness, efficiency and sustainability of production processes, address regulatory compliance and foster standardization of best practices across plants.
What are the essential requirements for a pharmaceutical business to successfully implement process development and tech transfer solutions?
To successfully implement process development and tech transfer solutions, a pharmaceutical business needs the following:
- The ability to manage product and process specifications across the drug lifecycle, including all assets linked to a product, such as recipes, MES workflows, parameter scaling and process knowledge
- A digital backbone for efficient data collection and pre-processing in a laboratory to speed up the decision-making process
- Real-time site capability check to select the right facility
- Seamless tech transfer of the master recipe to the shop floor or a CMO. This is accomplished by leveraging an up-to-date overview of all internal and external production lines, including processing capabilities, working ranges and materials substitutions