Decentralized Manufacturing - It’s not just about ATMP’s!

In the current zeitgeist of pharmaceutical development and manufacturing the concept of ‘decentralized manufacturing’ has gained significant traction, propelled by the rise of Advanced Therapy Medicinal Products (ATMP’s). While ATMP’s have sparked discussions on this topic, particularly in the context of cell and gene therapies being produced at the patient's bedside, many of the key principles of decentralized manufacturing can and should extend beyond ATMP’s to encompass both traditional large and small molecule medicines. Embedded within this paradigm shift lies the crucial concept of Process Portability — a concept which encompasses the seamless transferability of manufacturing processes across different facilities or locations without compromising product quality or efficiency.

Extending Decentralized Manufacturing to Traditional Medicines

As the pharmaceutical industry navigates the challenges and opportunities presented by ATMPs and traditional medicines, Process Portability emerges as a strategic imperative. This concept offers significant benefits for traditional medicines, allowing pharmaceutical companies to diversify their manufacturing footprint and mitigate risks associated with supply chain disruptions. Embracing Process Portability enables companies to streamline process transfer protocols, optimize resource utilization, and maintain regulatory compliance across various manufacturing sites.

Achieving Process Portability requires a deep understanding of the processes involved in producing a medicine within any given manufacturing infrastructure. This includes identifying and truly understanding critical process parameters and knowing how they vary under different operating conditions, such as reactor geometry, mixing, and heating/cooling capabilities.

Unlocking the Benefits of Process Portability

The focus on process understanding leads to Process Portability and offers a new form of manufacturing decentralization that liberates companies from relying on a single CDMO. This strategy provides several key benefits:

Adaptability

Flexible manufacturing platforms, such as continuous production systems, combined with Process Portability initiatives, enable companies to respond swiftly to market demands, regulatory changes, and emerging therapeutic trends. By leveraging modular and scalable manufacturing technologies, companies can optimize production volumes and formulations to meet evolving patient needs.

Ownership of Process Knowledge Leading to More Secure Supply Chains

In an era marked by geopolitical uncertainties, supply chain disruptions, and global health crises, resilience is crucial. Process Portability allows companies to avoid dependence on a single CDMO for key intermediates or active ingredients. At the heart of decentralized manufacturing and Process Portability is the critical principle of ownership of process knowledge. In this forward-thinking model, it is the medicine developers — not the CDMOs — who possess and control the intricate knowledge of their manufacturing processes. This ownership empowers medicine developers with the autonomy to determine how and where their processes are deployed, ensuring flexibility and resilience in production. By retaining control over their proprietary know-how, developers can seamlessly transfer production across multiple facilities, optimize manufacturing efficiencies, and mitigate risks associated with supply chain disruptions. This strategic control not only safeguards the integrity and quality of the medicines but also reinforces the developer's ability to swiftly respond to market demands and regulatory changes, ultimately enhancing their competitive edge in the pharmaceutical landscape.

It also facilitates the diversification or repatriation of the manufacturing footprint, mitigating risks associated with disruptions and ensuring uninterrupted access to essential medications for patients worldwide.

Innovation

A culture of deep process understanding, driven by Process Portability, can lead to efficiency gains, cost savings, and product enhancements. Utilizing advanced technologies such as automation, digitalization, and data analytics enhances process robustness, accelerates product development timelines, and fosters operational excellence.

Patient-Centricity

Ultimately, decentralized manufacturing prioritizes patients, ensuring they receive the medicines they need when they need them. Whether it's producing custom-made gene therapies or ensuring widespread access to common medications like statins, Process Portability ensures timely delivery of the right treatments.

Embracing the Future of Pharmaceutical Manufacturing

As the pharmaceutical industry embraces decentralized manufacturing, proactive engagement, collaboration, and innovation are essential. Companies must look beyond the narrow focus on ATMPs and invest in process understanding to unlock the full potential of Process Portability across diverse therapeutic modalities.

While ATMPs have sparked discussions on new manufacturing methods, the principles of Process Portability extend far beyond cell and gene therapies to traditional medicines. Process Portability embodies flexibility, resilience, innovation, and patient-centricity, enabling pharmaceutical companies to navigate the complexities of the modern healthcare landscape and deliver life-changing medicines to patients worldwide.

Learn more about Process Portability

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Watch the Q&A session where APC Experts Define ‘Process Portability’