These days there has been lots of talk about injectables – especially when it comes to COVID-19 vaccines. But aside from vaccines, drug are produced in injectable form to treat a variety of conditions. The benefits of injectable drugs are that they provide rapid delivery of a drug or vaccine , and can often be targeted to a specific location, such as the cornea to treat eye disease (ophthalmic). Unlike drugs delivered in pill form, injectables don’t have to travel through the body before they reach their ultimate destination – it’s more of a straight shot. Yet, injectables aren’t always needed, or helpful for many chronic conditions when pills are more convenient and just as effective. Yet, when they are needed, injection of drugs can be delivered as intradermal (between the layers of the skin), as subcutaneous injection (in the fat layer) and intramuscular (in the muscle) injections.
Regardless of the way injectable drugs are delivered, the fact that they directly enter the bloodstream makes their safety and sterility of critical importance. The dangers of not heeding extreme care for sterility was all too evident in 2017 quite tragically at the New England Compounding Center. Tainted steroid injections caused hundreds of people across the country to become infected with meningitis.
Because of their potential to cause harm or death if not manufactured properly, the Active Pharmaceutical Ingredients (APIs) that are delivered via injection in finished drug products must follow rigorous quality controls standards to ensure the sterility of the drug and the elimination of residual toxins. For this reason, only the most qualified and experienced Contract Development & Manufacturing Organizations (CDMOs) should be considered to produce them.
Below are five best practices and Standard Operating Procedures (SOPs) that we at Seqens CDMO NA follow when it comes to manufacturing injectables:
Manufacturing for injectables can be a specialized expertise and we’re fortunate to have the skill-set and GMP facilities here in Newburyport to support it. Our capacity, however, is for smaller batches, yet being part of a global CDMO, enables us to provide our sponsors with the ability to scale up production for very large quantities from our sister plant in Finland, which specializes in them.
Critical drug ingredients that directly enter a patient’s bloodstream can be a lifesaver, yet proper precautions must be taken with injectables to ensure their safety though effective clean room procedures and sterile conditions. It’s an exact science that leaves no room for errors.
For more insights, check out: Whose Manufacturing Your Prized API?, How to Stem the Flow of Tainted Generic Drugs, or Coming Clean on Cleanroom Operations in GMP Manufacturing. Please consider singing up for our newsletter here.