Close to three years ago, when we announced our capabilities for controlled substance development and manufacturing, we had no idea just how great demand would become for Contract Development & Manufacturing Organization (CDMO) services in this space.
By putting in place the infrastructure, processes and expertise to manufacture controlled substances and becoming registered with the Drug Enforcement Administration (DEA), we’re meeting the growing demand for new molecules that make use of the medical value of controlled substances. We now have three cGMP suites equipped to produce them.
While the manufacture of all new chemical entities (NCEs) and Active Pharmaceutical Ingredients (APIs) takes stringent requirements and follow all of the same steps, manufacturing controlled substances takes some of those requirements to a whole new level of quality control, in order to comply with state and federal regulations.
What actually makes a substance a controlled one? According to the U.S. FDA, it needs to have an accepted medical use for treatment in the United States, along with a likelihood of causing dependence when abused. Most prescriptions for chronic conditions, such as high blood pressure or high cholesterol, asthma or diabetes, are non-controlled. In contrast to them, controlled substances are medications that can cause physical and mental dependence, and the manufacturing, possession and use of these medications is regulated by law. Some examples of controlled substances include opioid pain medications like Vicodin, or ADHD medications such as Adderall.
Put into law in 1970 by Congress, the Controlled Substances Act (CSA) has been used by U.S. law enforcement to decrease drug abuse and dependence among Americans by regulating the production, sale, purchase and use of many drugs. This act gives authority to the DEA to monitor and control the use of substances, both legal and illegal. Because of the many differences between the various categories of controlled substances, consider the following: Schedule 1 drugs have no medical value and high potential for abuse, while schedule 2 through 5 substances all have some medical value but differ in ranking depending on their potential for abuse.
European countries also follow similar guidelines regarding the designation of controlled substances and their classification. These guidelines were based on United Nations Conventions of 1961, 1971 and 1988, controlling and supervising the legitimate scientific or medical use of controlled substances, while taking into account the particular risks to public or individual health.
Seqens CDMO N.A. has approval to develop products that fall in the Schedule 2 through 5 range in the U.S. To put that into context, Schedule I substances, include drugs such as heroin, while Schedule 2 includes methadone or oxycodone; and schedule 5 includes cough preparations, such as Robitussin.
As mentioned above, manufacturing controlled substances is similar to manufacturing other chemicals, but requires extra diligence in in two key areas:
Pharmaceutical companies that look to outsource the development and manufacture of DEA controlled substances need a partner that is equipped to perform cGMP processes, as well as more specific requirements to ensure proper management of risk throughout the manufacturing process. So how do you know you’re selecting a CDMO equipped to handle your controlled substance project? It involves asking the following five questions:
Despite the increasing attention that controlled substances get when it comes to their abuse and mistreatment, they also provide effective treatment for a variety of conditions when used correctly according to their intended purpose. It pays to do your homework when choosing a CDMO so that you can select a partner that can help you bring these critical drugs to market safely and effectively.