The Stages behind Developing a New Drug in Industry … Part 5

In this final installment of the series on Drug Development, we examine stage 4 and the effort involved in Drug Manufacturing and Process. The 4th stage begins with a large scale production of the new drug, followed by formulation studies and then ending with regulatory reviews of the entire process before the drug can be marketed and sold.

The new drug is batched produced through a scale-up synthesis of the active drug component. At this point, new impurities may surface and thus warrant further investigations into its toxicity effects. Each impurity must be identified, elucidated, re-synthesized and re-tested to ensure all safety precautions were taken.

On the formulation side, further studies are done to ensure that the active drug ingredient and its impurities are combined with an excipient that is compatible and that the dosage upon intake is consistent. In addition, stress tests are performed on the mixture to check for any harmful degradation products that may occur during storage. These studies tend to overlap with the Drug Trials set in stage 3.

For good measures, all the analyses and tests are scrutinized by a team of internal and external experts. They verify that all the correct procedures were applied and the data is consistent with what is intended to be sold.

The Stages behind Developing a New Drug in Industry … Part 5

In this final installment of the series on Drug Development, we examine stage 4 and the effort involved in Drug Manufacturing and Process. The 4th stage begins with a large scale production of the new drug, followed by formulation studies and then ending with regulatory reviews of the entire process before the drug can be marketed and sold.

The new drug is batched produced through a scale-up synthesis of the active drug component. At this point, new impurities may surface and thus warrant further investigations into its toxicity effects. Each impurity must be identified, elucidated, re-synthesized and re-tested to ensure all safety precautions were taken.

On the formulation side, further studies are done to ensure that the active drug ingredient and its impurities are combined with an excipient that is compatible and that the dosage upon intake is consistent. In addition, stress tests are performed on the mixture to check for any harmful degradation products that may occur during storage. These studies tend to overlap with the Drug Trials set in stage 3.

For good measures, all the analyses and tests are scrutinized by a team of internal and external experts. They verify that all the correct procedures were applied and the data is consistent with what is intended to be sold.

The Stages behind Developing a New Drug in Industry … Part 3

The main focus surrounding the Drug Design stage (see diagram in Part 1) is to optimize the hit compound(s) and produce analogues that will increase the activity at the target site. Lead optimization is accomplished through minor modifications of the hit compound.

In Drug Design, medicinal chemists aim to build a diverse library of compounds using the hit compound(s) as a blue print for synthesis. On the flip side, an increase in the compound’s toxicity can have it rejected from the library. For this purpose, many pharmaceutical companies apply at this stage an early ADME/Tox (Absorption, Distribution, Metabolism, Elimination/Excretion and Toxicity) screening.

The Stages behind Developing a New Drug in Industry … Part 3

The main focus surrounding the Drug Design stage (see diagram in Part 1) is to optimize the hit compound(s) and produce analogues that will increase the activity at the target site. Lead optimization is accomplished through minor modifications of the hit compound.

In Drug Design, medicinal chemists aim to build a diverse library of compounds using the hit compound(s) as a blue print for synthesis. On the flip side, an increase in the compound’s toxicity can have it rejected from the library. For this purpose, many pharmaceutical companies apply at this stage an early ADME/Tox (Absorption, Distribution, Metabolism, Elimination/Excretion and Toxicity) screening.

The Stages behind Developing a New Drug in Industry

Many new medicinal drugs produced by pharmaceutical companies follow a very similar pathway starting from the inception of the project idea and ending at the shelves of a pharmacy. Each stage in the development of the drug involves various types of chemists, each lending their expertise at synthesizing, extracting, analyzing and testing the new drug.

The following diagram presents a simplified summary in the development of a medicinal drug. The general stages are 1. Drug Discovery, 2. Drug Design, 3. Drug Trials and 4. Drug Manufacturing/Process.

 

 Please note that this overview may not apply to all cases.

The Stages behind Developing a New Drug in Industry

Many new medicinal drugs produced by pharmaceutical companies follow a very similar pathway starting from the inception of the project idea and ending at the shelves of a pharmacy. Each stage in the development of the drug involves various types of chemists, each lending their expertise at synthesizing, extracting, analyzing and testing the new drug.

The following diagram presents a simplified summary in the development of a medicinal drug. The general stages are 1. Drug Discovery, 2. Drug Design, 3. Drug Trials and 4. Drug Manufacturing/Process.

 

 Please note that this overview may not apply to all cases.