In medical circles, preparation and formulation of a new drug is not an easy task. However it still has to be undertaken since the lives of patients depend on it. These form the basis of protein formulation development which is the process tasked with combining two or more elements to form a drug for a given medical purpose.
Developing commercial formulations requires a clear understanding of potential market as well as the patient the drug is intended for. For example, indications, method of delivery, frequency of dosing, typical dose requirements and the like. These kind of information will provide directions for the design of a successful formulation.
It is also important to consider the competitiveness of the formulation as compared to other products available in the market. This is in terms of the stability of the drug as well as the resources it needs in its development process. This is in light of the fact that proteins have issues pertaining to their stability, which is caused by their delicate structural makeup.
In the long run, the most ideal situation would be to develop a drug from only the most pure and stable proteins. However, it is has proven impractical and to some level impossible to have the pure form. This is because the protein must be extracted from a compound mixture of a pool of other proteins. The compound pool is limited since it has weak and inefficient protein strands.
There exists a major challenge in maintaining the integrity of a purified protein. This is especially the case during pharmaceutical procedures of processing, storage, handling, and delivery to the patient. This goal could nevertheless be achieved l by developing a formulation with perfect stability. This perfectly stable strand would have no physical and chemical change.
Proteins have complex yet delicate structures characterized by a three dimensional look. When it comes to identifying conditions for their stability, it proves infinitely impossible. When developing the strands for commercial purposes, it is inevitable to have some physiochemical changes. Formulations development focuses on determining potential degradation pathway, assessing the significance of each and optimizing variables to reduce degradation products which are clinically significant.
Commercially viable and market competitive formulations have some common features. Most of all, the formulation should maintain the safety and efficacy profile of the protein drug during all the handling and uses specified on the label. Since commercial distribution channels are not always equipped for frozen products, shipping and storage at refrigerated temperature or higher are required.
There exists certain regulations on the testing and safety of personnel as well the samples. These guidelines also outline the necessary steps in collection and storage. They also extend to pre-clinical tests which should always be conducted before the formulation development process.
With these levels of advancement in the process of protein formulations development, regulatory framework limitations, as well as the challenges facing the medics and the process entirely, it is not easy to propagate such experiences to the real world to produce drugs for every need. There must be more research and development towards eliminating such barriers.
Developing commercial formulations requires a clear understanding of potential market as well as the patient the drug is intended for. For example, indications, method of delivery, frequency of dosing, typical dose requirements and the like. These kind of information will provide directions for the design of a successful formulation.
It is also important to consider the competitiveness of the formulation as compared to other products available in the market. This is in terms of the stability of the drug as well as the resources it needs in its development process. This is in light of the fact that proteins have issues pertaining to their stability, which is caused by their delicate structural makeup.
In the long run, the most ideal situation would be to develop a drug from only the most pure and stable proteins. However, it is has proven impractical and to some level impossible to have the pure form. This is because the protein must be extracted from a compound mixture of a pool of other proteins. The compound pool is limited since it has weak and inefficient protein strands.
There exists a major challenge in maintaining the integrity of a purified protein. This is especially the case during pharmaceutical procedures of processing, storage, handling, and delivery to the patient. This goal could nevertheless be achieved l by developing a formulation with perfect stability. This perfectly stable strand would have no physical and chemical change.
Proteins have complex yet delicate structures characterized by a three dimensional look. When it comes to identifying conditions for their stability, it proves infinitely impossible. When developing the strands for commercial purposes, it is inevitable to have some physiochemical changes. Formulations development focuses on determining potential degradation pathway, assessing the significance of each and optimizing variables to reduce degradation products which are clinically significant.
Commercially viable and market competitive formulations have some common features. Most of all, the formulation should maintain the safety and efficacy profile of the protein drug during all the handling and uses specified on the label. Since commercial distribution channels are not always equipped for frozen products, shipping and storage at refrigerated temperature or higher are required.
There exists certain regulations on the testing and safety of personnel as well the samples. These guidelines also outline the necessary steps in collection and storage. They also extend to pre-clinical tests which should always be conducted before the formulation development process.
With these levels of advancement in the process of protein formulations development, regulatory framework limitations, as well as the challenges facing the medics and the process entirely, it is not easy to propagate such experiences to the real world to produce drugs for every need. There must be more research and development towards eliminating such barriers.
