Author: M. Elena Laguardia

In the CDMO biotech landscape, translating innovation from Research and Development (R&D) to the GMP operational environment represents a critical and indispensable phase in the lifecycle of a pharmaceutical product. Drawing on years of extensive experience encompassing both domains, we recognize how the success of this transition determines the actual ability to transform promising discoveries into tangible therapies for patients.

This transfer is not simply a transmission of technical data, but rather a complex strategic process that demands meticulous planning and profound cross-functional synergy. The primary imperative is to establish an inherently robust industrial-scale production process, characterized by reliable reproducibility and the capacity to continuously generate a product that meets the highest standards of quality, safety, and therapeutic efficacy.

Continuity in R&D to GMP Technology Transfer

At Diatheva, the translation from Research and Development (R&D) to GMP production stands out due to an intrinsic element of strength: the continuity of know-how. Our approach is built upon a cohesive team where professionals with profound expertise gained in the pioneering phases of research actively participate in GMP operations as well. This unique characteristic of our company ensures an unparalleled understanding of the product, its development, and the critical quality parameters right from the initial conceptual stages.

Principles for a Successful Technology Transfer

The efficacy of our transfer process rests on key principles:

  • Comprehensive and Traceable Technical Documentation: At Diatheva, our technical documentation is both complete and fully traceable, a direct result of our team’s collaborative effort. Those with intimate knowledge of the product’s development, having been involved from the outset, meticulously elaborate development protocols, analytical data, quality specifications, and process procedures, ensuring unparalleled coherence and depth.
  • Proactive Risk Mitigation Through Experienced Insight: Diatheva’s risk management strategy during transfer is strengthened by the direct involvement of professionals who possess firsthand experience in the complexities of scale-up, gained through active participation in laboratory and pilot stages. This direct insight allows for sharper analysis and the development of more effective mitigation strategies.
  • Product Knowledge Drives Effective Scale-up: A deep understanding of a product’s intricacies, especially when originating from the R&D team, is crucial for optimizing the shift to industrial-scale manufacturing. This comprehensive insight ensures a more streamlined and logical scale-up, significantly increasing the likelihood of successful implementation from the beginning.
  • Continuous and Qualified GMP Training: GMP personnel receive specialized and continuous training on new processes, equipment specifications, and product characteristics. This training is provided by recognized bodies, ensuring a constant update of skills in compliance with GMP standards.
  • Robust Validation Based on Solid Scientific Expertise: The validation of production processes is a rigorous process that benefits from the presence of professionals with a strong scientific background and an in-depth understanding of the product acquired during its development. This ensures targeted and effective validation.
  • Cohesive and Highly Qualified Technical Support: Communication and technical support between the development and production phases are fluid and highly qualified, thanks to personnel with integrated skills. This facilitates the resolution of issues, and the implementation of improvements based on a shared knowledge of the product and the process.

Ensuring Pharmaceutical Innovation Through Reliable Transfer

An effective transfer of processes and information from R&D to GMP is a fundamental pillar for the success of the pharmaceutical industry. Investing in well-defined technology transfer strategies, with particular attention to GMP quality, Italian regulatory compliance, and the optimization of production processes, will ensure the supply of innovative and safe drugs to patients.

 

Maria Elena Laguardia is the Site Manager and Qualified Person at Diatheva. With a PhD in Biochemical and Pharmacological Methodologies, she oversees the site’s operations and ensures compliance with regulatory standards. She plays a crucial role in product development and maintaining operational excellence within the Biotech CDMO division.