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.
Due to the complexity of its structure, and since it is also very delicate, it is practically impossible to extract a pharmaceutical drug containing only the native and pure protein. The process would prove futile due to inefficiencies from the denatured and degraded protein forms. The very process would prove to be too expensive resource wise.
Maintaining the integrity of this protein would be difficult, even with the extraction of pure strands. The shelf life would be drastically reduced and the instability of the same heightened. The processes of handling and transportation and delivery would need to be done with extreme caution. However, the strand would have the advantage of having neither chemical nor physical change.
Chemists and researchers have come to the realization that it is practically impossible to keep any protein sample pure and stable. This is caused by their complex structures, which are predominantly three dimensional. Therefore, medical research and further formulations development is carried out with the mindset that the change in chemical composition is inevitable.
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.
Various methodical studies need to be carried out to ensure full compliance with regulatory requirements for registration. However, the challenge is that it takes a year or two to collect the results. For efficiency purposes, the commercial formulation should continue in the process of development while preclinical studies and clinical trials are underway.
Commercial formulation should be introduced before the commencement of clinical trials because clinical experience is the most effective way to confirm the safety and efficacy aspects of formulation. In addition, formulations change after this point may introduce formidable challenges to the clinical program and to obtaining regulatory approval.
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.
Due to the complexity of its structure, and since it is also very delicate, it is practically impossible to extract a pharmaceutical drug containing only the native and pure protein. The process would prove futile due to inefficiencies from the denatured and degraded protein forms. The very process would prove to be too expensive resource wise.
Maintaining the integrity of this protein would be difficult, even with the extraction of pure strands. The shelf life would be drastically reduced and the instability of the same heightened. The processes of handling and transportation and delivery would need to be done with extreme caution. However, the strand would have the advantage of having neither chemical nor physical change.
Chemists and researchers have come to the realization that it is practically impossible to keep any protein sample pure and stable. This is caused by their complex structures, which are predominantly three dimensional. Therefore, medical research and further formulations development is carried out with the mindset that the change in chemical composition is inevitable.
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.
Various methodical studies need to be carried out to ensure full compliance with regulatory requirements for registration. However, the challenge is that it takes a year or two to collect the results. For efficiency purposes, the commercial formulation should continue in the process of development while preclinical studies and clinical trials are underway.
Commercial formulation should be introduced before the commencement of clinical trials because clinical experience is the most effective way to confirm the safety and efficacy aspects of formulation. In addition, formulations change after this point may introduce formidable challenges to the clinical program and to obtaining regulatory approval.
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