Project Sprint provided GEA with an opportunity to collaborate with key customer, supplier and academic groups as part of a strategy to develop a new generation of process intensification systems for drug product development and subsequent manufacturing.
Continuous Tableting and Coating
Continuous oral solid dose (OSD) manufacturing provides significant benefits in cost of implementation compared with batch manufacturing through reductions in time and drug substance required for development, facility footprint, a simpler, product-based manufacturing process and a flexible facility that can be configured for different processes and products.
The deliverables from the project included
- proof that an integrated continuous tablet production system is a viable platform for both cost-effective drug product development and a flexible compact and robust manufacturing platform wherein scale up in time eliminates the technical and cost issues associated with traditional scale-up in batch size
- the development and demonstration of an integrated continuous blending and direct compression system for tablet production with online product quality attribute measurement
- demonstration that online measurements, together with a data management system to synchronize the data, in conjunction with a process that has a well-defined residence time distribution, can provide the information required for both active process control and quality assurance
- the development and demonstration of a continuous tablet coating system that delivers homogenous coating that’s better than conventional batch coating systems and is compatible with both the need to coat small quantities of material during development and yet provide the capacity required for production.
The partnership highlighted the value of considering both the flow of physical product and the flow of information required to ensure that the product emerging from the system met the required quality specifications. The pivotal element of this test work was a number of extended continuous trials that showed convincingly that the technology was able to robustly produce a high quality product during an extended period.
The close coupling of the blending process to the tablet production step eliminates many of the concerns regarding blended product segregation during transport and storage, meaning that this process could be used a robust manufacturing method for a wider range of products, particularly where a low cost method of local manufacturing is needed for new markets.
Analysis by GSK of the coating deposition showed that the new ConsiGma™ coater was capable of achieving a move even coat distribution than existing coating technology.
Continuous Direct Compression
Analysis of tablets containing API concentrations between 10 and 45% produced using the integrated direct compression system showed that the RSD% content homogeneity measured was within the range 0.6–2.2%, which was considered to be well within the required specification. Online analysis of blended powders using NIR initially showed that the data was sensitive to material presentation and this led to the development of a novel method of presenting material to the NIR in a contained and consistent manner. The project also delivered a new process control platform for the GEA continuous range of products.