The manufacturing landscape for cell and gene therapies is evolving rapidly, driven by the need for greater flexibility, efficiency, and proximity to patients. Two prominent models have emerged: Distributed Manufacturing (DM) and Point of Care Manufacturing (POC-M). Both approaches have unique benefits and challenges, particularly concerning quality control and regulatory compliance. This blog explores the intricacies of these models and highlights the critical considerations for maintaining product consistency and quality.
Distributed Manufacturing (DM) involves producing therapies at multiple decentralized facilities. Initially, manufacturing may begin at a centralized facility before being dispersed to decentralized locations to serve various regions. These facilities would typically contain GMP environments that are similar to those of traditional manufacturing facilities.
Point of Care Manufacturing (POC-M) takes a different approach with manufacturing occurring at host sites in close proximity to patient care, such as hospitals or clinics. This model allows for on-demand production of cell and gene therapies, which can be particularly beneficial for personalized treatments. These facilities would typically be non-traditional GMP environments, such as hospitals or clinics, and, likewise, the operators at these facilities may not have the same experience as operators at traditional manufacturing facilities.
Regardless of the chosen model, manufacturing and analytical comparability as well as quality oversight are required. To achieve manufacturing comparability, it is recommended to compare all sites to a single “reference” site. This involves using the same SOPs, reagents, and equipment across all facilities. For analytics, a similar approach is recommended. Comparing all sites to a single reference site, conducting side-by-side testing of the same material, and using reference materials as part of system controls are essential steps. Centralized quality oversight is recommended for both models to ensure consistency and control between all manufacturing and testing sites.
Both Distributed Manufacturing (DM) and Point of Care Manufacturing (POC-M) offer significant advantages for the production of cell and gene therapies. Distributed Manufacturing (DM) has the benefit of using traditional GMP manufacturing facilities and operators, and Point of Care Manufacturing (POC-M) has the benefit of near on-demand production and delivery to the patient. However, each comes with its own set of challenges, particularly concerning maintaining manufacturing and analytical consistency and quality oversight across the various manufacturing and testing sites.
If you or your firm are considering implementing either of these manufacturing models and have questions on how to do so in a fully GXP-compliant manner, Lachman can help! Reach out to us to schedule a consultation at LCS@LachmanConsultants.com.
