PD & Tech Transfer for GMP Manufacturing

PD & Tech Transfer for GMP Manufacturing

Process Development (PD) lays the foundation for efficient, safe and compliant GMP manufacturing, significantly influencing the overall success of your mRNA-LNP therapeutic product in the market. In addition, PD is essential for ensuring consistency, quality, scalability and robustness while reducing risk.

If your internal team is conducting PD, they must adopt a wide range of automation, analytical and digital solutions. A Beckman Coulter Life Sciences Optima AUC allows for precise quantification of LNP loading states, hydrodynamic radius and RNA copy number distributions.

The analysis of lipids and lipid impurities, mRNA poly(A) tails and 5’-caps can be performed using a SCIEX ZenoTOF 7600+ system for data-driven decision-making. The SCIEX BioPhase 8800 system and PA 800 Plus system utilize capillary electrophoresis to test mRNA integrity and purity and estimate size and encapsulation efficiency. Known analytes can be quantitatively monitored using the SCIEX 7500+ system with SCIEX OS software.

Comprehensive data management systems facilitate the transfer of processes from research and development to Good Manufacturing Practice (GMP) settings. This includes maintaining detailed records of process parameters, quality control measures and batch records, ensuring compliance with regulatory standards and enabling scalable production. Streamlining the consolidation and organization of drug substance and drug product data is vital for efficient PD and tech transfer. Genedata and IDBS provide scalable, enterprise-level cloud software products from R&D through manufacturing for assured confidence in both GxP and non-GxP environments.

Genedata Biopharma Platform offers advanced data management and analysis tools to streamline PD and manufacturing workflows. The platform structures and integrates PD data across different technologies, enabling smooth information handover between teams. Out-of-the-box, it automates MS-based quality control through approved workflows, ensuring seamless transfer to GMP manufacturing. It facilitates painless submission of MS data to regulatory agencies and is validation-ready for GMP use. Genedata enables effective development and optimization of manufacturing processes through enhanced efficiency, reliability, and regulatory compliance, ensuring consistent production of high-quality and safe mRNA-LNPs.

IDSB Polar cloud software is a robust solution designed to optimize process development (PD) and tech transfer. By capturing and connecting execution, inventory, analysis and operational data with process and parameter lifecycle data, PD teams can maintain accurate process documentation, curate contextualized analytics-ready data, enable actionable insights and drive data-driven decision-making.

If your laboratory lacks the necessary safeguards and personnel—requirements that often require significant investments—or if you prefer not to manage multiple partnerships, consider outsourcing your LNP work to a reliable partner like Aldevron. Aldevron can support you throughout the entire mRNA-LNP therapeutic process, from creating plasmids and mRNA to analytical development, validation, and regulatory support, all the way through to process development and manufacturing.

To enhance GMP manufacturing, the IDBS PIMS software platform can be used for a 21 CFR Part 11 compliant digital backbone and end-to-end analytics workspace. By doing so, it is possible to seamlessly combine product and process data, resulting in reduced production costs, fewer batch failures and easier regulatory reporting. IDBS PIMS allows you to easily transfer your PD data and process to your GMP manufacturing partner.