When it comes to chemistry, people have pretty wacky associations with it. Some people will think of narcotics and meth labs, while others will think about relationships. It is a shame that there are only a few people who can show off chemistry in its rightful glory. One of the many things that chemistry brings us is the many medications that all of us use. If it were not for organic synthesis, there would not be a lot of cures to go around.
However, designing a cure is much more complicated than mixing a few things in a flask. There are many steps to this long, but very beautiful process of making a life-saving cure. This is a very delicate job that if not done right can result in making poison and not a cure. This is why it is important to do this right and make your product stand out from the rest of the potential pharmaceutical industry. With the help of a CDMO, it is possible to increase the competitiveness of your product.
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What Is A CDMO?
CDMO is short for Contract Development and Manufacturing Organization, which is why the acronym is very useful. The drug market discovery pipeline is, as stated over at https://www.renpharm.com/what-is-a-cdmo/, filled with many challenges, many would be an understatement. This is where partnering up with a CDMO makes the whole ordeal simpler. Not only is the whole process simpler, but a CDMO is there to lower the risk.
Every scientist experienced with pharmaceuticals knows that discovering a drug is one thing. However, what lies ahead is a sea of other tests, R&D, and your need to manufacture the drug. A CDMO is there to help out with every step along the way because this is not a one-man job. New drugs were brought into the market because big and multidisciplinary teams worked on such projects.
Science vs. logistics
As a scientist, whether a chemist or a biochemist, you know how to make a drug. You know how your drug will work, and you know the science behind the mechanism of action and synthesis. You made this drug with your colleagues using your incredible wit and brains. However, you are all experts when it comes to science, but you are not experts in logistics. You can not be a master of all trades, and you should not be one because you already have your duty.
Once you have synthesized a drug with proven pharmaceutical activity, that is only the start. You can not do the rest of the job with your scientific colleagues. You need to let the experts in this other field take over the process if you want your drug to hit the market. A CDMO can make your product more competitive because they take care of jobs you can not handle. With this coordination and a CDMO, you are making sure that everyone does their duty properly.
Once your drug gets past the in vitro and in vivo models, it is time for the clinical stages. Once these stages are clear, it is time for the FDA to review the drug. Even when the FDA gives the green light, the FDA will continue to monitor your drug on the market. This is not a job that is organized for you, it is a job that requires a lot of attention and a lot of paperwork. Even though there is still a scientific side left during testing, there is also an administrative side to it.
During testing, you will need medical experts to help you with different patients. Besides this physical job, you will need a team of legal experts to deal with the administrative side of clinical trials. A CDMO is there to provide you with both the medical experts and the experts on the legal matter. These are the things that people rarely think about when it comes to drug research, yet they are integral to the whole process.
Drug manufacturing is different from just synthesizing the drug in a lab. In a lab, you are working on a small scale and the manual labor is minimal. However, you can not keep that up, you need to make your drug on a much bigger scale. This process requires serious reactors and serious investment into the equipment, whether it is a pure organic synthesis or enzymatic synthesis. A CDMO is there to provide you with the necessary equipment for large-scale manufacture.
Besides the equipment, you will also need to optimize the entire process. Working on a larger scale requires different techniques compared to techniques available in the lab. The process also needs to be as efficient as possible, which means no half measures. This up-scaling requires a lot of work, and a CDMO can help out with that. With the additional manpower, you will be able to optimize this synthesis much faster than on your own.
All in all, having a bigger picture of everything in life, including drug development, is vital. Stick to a good command of the field, and you can thrive well if you wish to switch your career path.
This is a very tedious process that can not be explained in just a few sentences, and that is just theory. In practice, every drug development process is different from the other. This is why it is important to have a proper team of professionals to help you when the unexpected occurs.
This is why it is important to understand the entire process in order to understand the benefits of a CDMO. By understanding the process, you can understand the underlying beauty of solving such problems.