Pharmaceutical process development and tech transfer

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.

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.

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.

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.

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.

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