Biologically designed medicines are altering the lives of more people across the globe; however, the increasing complexity of molecules means the development of the correct manufacturing process is not a simple task. Optimised manufacturing processes produce a highly purified material in a minimal number of batches to meet any deadlines and support commercial treatment launches. This needs to be done while still maintaining the quality, supply, and cost of the medicines. Furthermore, an optimised design process and assay development needs to streamline all operations, increase the robustness of the medication with consistency in production and reduced the chance of failure. Engineering is another area that needs to be considered. Optimised engineering controls can prevent and contamination of the product and avoid introducing adventitious agents to the medicine. All of these factors can lead to a successful long-term manufacturing procedure.
When examining the optimisation process, one must ask oneself three important questions:
1. Can The Process Be Simplified?
A project that can be easily completed on a small-scale can result in variability of large-scale GMP settings and the unnecessary associated risk. The risk of failure can be reduced dramatically if the complicated feeding strategy is replaced by a simple approach. A reduction in contamination risk is possible if open manipulations of the material is replaced with closed systems. It is also possible to reduce variability of GMP environments by streamlining the cell expansion and media preparation.
2. How Can I Ensure That There Is Consistent Performance?
The closer one comes to a commercial manufacturing operation the more batches will need to be completed with robustness and consistency being highly significant. This is particularly true if the project aims for commercial manufacturing of several batches per month or, perhaps, dozens of batches per year.
3. How Can Upstream Processing Affect The Downstream Process?
It is important to consider the implications of downstream processing when using an upstream approach. A successful batch can be consistently manufactured when using a purified downstream.
When examining the quality of a material, it is vital you keep two factors in mind: the quality of the raw material and the quality of the final product. Increasing research indicates that the quality of a raw material involves the absence or presence of impurities in production. Not only do these elements (or absence of elements) influence the process performance but it can impact the quality of the produced substance. Taking this into account, it is essential that one understands the quality of raw materials in production and how they are being used and how they compare to the product used in clinical or commercial manufacturing.
4. Use A More Holistic Approach
Management of raw material supplies can be overwhelming, and collaboration is required to increase the chance of success. Rather than focusing on the functional elements of the downstream or upstream process, a more holistic approach can result in the successful production of the material. As the years’ progress, the FDA expects more effort in manufacturing by pharmaceutical companies to be successful. It is particularly important to consider supply chain transparency, which is another reason for collaboration with material suppliers. In this case, all parties have a better understanding of where the raw materials were sourced, how they should be utilised, and the management of the entire production process.
The significance of a strong relationship with material suppliers cannot be over-emphasised. This relationship affects all areas ranging from performance and product quality to the assurance of material supplies. You must be certain that suppliers will provide exactly what is required so that one can effectively troubleshoot process deviations. It is often difficult to locate the root cause of the issue; however, a close and trusted relationship with suppliers can assist in assessing raw materials.