What CMC Professionals Can Learn from Michael Jordan

“To achieve greatness, you must trust the process.”, Michael Jordan. Michael Jordan's words, though meant for the basketball court, resonate profoundly within the realm of pharmaceutical manufacturing. For any medicine developer, the bedrock of any competent CMC strategy is a process one can trust. This trust is paramount for achieving Process Portability, the seamless transfer of production across various facilities. Such operational flexibility hinges on effective tech transfer, which itself is predicated on a deep, thorough understanding of the process.

But it is only through the meticulous and rigorous undertaking of process development can this in-depth understanding be achieved. This foundational stage ensures that manufacturing processes are not only efficient and scalable but also resilient and compliant with regulatory standards.

The Essence of Process Development

Process development is the backbone of pharmaceutical manufacturing, encompassing the design, optimization, and validation of production processes. It involves a detailed understanding of the chemistry, biology, and engineering principles underlying the production of a medicine. This stage is critical for ensuring that the manufacturing process is reproducible, scalable, and capable of maintaining product quality across different production sites.

Why Process Development Matters for Tech Transfer

1. Reproducibility and Consistency: Robust process development ensures that the manufacturing process can be reproduced consistently, regardless of the production site. This reproducibility is crucial for maintaining product quality and efficacy, which are non-negotiable in pharmaceutical manufacturing.

2. Scalability: Effective process development considers scalability from the outset. It ensures that processes optimized at the laboratory or pilot scale can be scaled up to commercial production without compromising product quality or yield.

3. Regulatory Compliance: A well-developed process incorporates stringent quality control measures and adheres to regulatory guidelines. This compliance is essential for smooth tech transfer and for meeting Good Manufacturing Practices (GMP) across different sites.

4. Risk Mitigation: Thorough process development identifies and mitigates potential risks associated with tech transfer. By anticipating and addressing challenges early in the development phase, companies can avoid costly delays and ensure a smoother transition between manufacturing sites.

Key Elements of Effective Process Development

1. Comprehensive Process Understanding: A deep understanding of the process, including critical parameters and their impact on product quality, is essential. This involves thorough experimentation and data interrogation to establish a robust process that can withstand variability.

2. Documentation and Knowledge Sharing: Detailed documentation of the process, including standard operating procedures (SOPs) and critical control points, facilitates effective tech transfer. Open and transparent knowledge sharing between development and manufacturing teams ensures that all stakeholders are aligned.

3. Advanced Analytical Tools: Leveraging advanced analytical tools and technologies, such as process analytical technology (PAT) and digital twins, enhances process understanding and control. These tools enable real-time monitoring and predictive modeling, supporting proactive decision-making during tech transfer.

4. Collaboration: Collaborative efforts between process development and manufacturing teams are vital. These efforts help ensure efficient use of time and resources by understanding at an early stage what the process needs to look like in order to perform well in a given manufacturing infrastructure.

Achieving True Process Portability

True Process Portability is realized when manufacturing processes can be transferred seamlessly and efficiently across different sites, maintaining consistent product quality and regulatory compliance. This level of portability is only achievable through robust process development, which lays the groundwork for reliable tech transfer. Companies that prioritize process development are better positioned to adapt to market changes, mitigate supply chain risks, and maintain continuous production in the face of disruptions.

However, despite their statements to the contrary, the focus of most CDMOs often remains on filling reactors rather than engaging in deep process development. True process understanding is often an afterthought. When medicine developers decouple process development from manufacturing it liberates them from the old paradigm where CDMOs force-fit client processes into their reactors without truly understanding the science underpinning those processes. Conversely, adopting a “science-first” approach ensures that medicine owners are in the CMC driver’s seat -empowered with ownership and understanding of the crucial information needed to determine the best reactor geometry, conditions, and equipment configuration for their specific product. As a result, clients have far more control and flexibility over where and how their medicines are manufactured.

Conclusion

In the quest for operational flexibility and resilience, the importance of process development cannot be overstated. No less than Michael Jordan, for CMC professionals being able to “trust the process” is the cornerstone of reliable tech transfer and the key to achieving true Process Portability. By investing in comprehensive process development, medicine owners can ensure that their manufacturing processes are robust, scalable, and compliant, enabling seamless transitions between production sites. This strategic focus not only enhances operational efficiency but also ensures that life-saving medications reach patients without delay, regardless of where they are produced.