The advent of biological drug productions is creating a shift in drug delivery. Instead of formulating small-molecule pharmaceuticals, biological drug production relies on engineering complex macromolecules – a process that changes regulatory practices, packaging systems, and drug administration. These changes ensure contaminants don’t interfere with final formulas, with the ultimate goal of creating safe self-administered drugs for patients to use in their own homes.
A new trend is seeing self-administered drugs in home settings in the form of prefilled syringes and autoinjectors. They offer more convenient options for users who may not wish to visit hospitals for financial or health-related reasons. Biologics used for chronic diseases are especially seeing a spike in home drug administration. Prefilled syringes are convenient for accurate drug delivery. Experts claim patients are more compliant when administering biopharmaceuticals themselves in the comfort of their own homes.
This trend continues to grow with the rise of a home healthcare market, and aging populations in established countries are using self-administered drugs to avoid costly and unpleasant trips to doctor’ offices.
Self-injection, though, still isn’t a pleasant experience, and patients prefer fewer injections of higher doses. This process questions how highly concentrated drugs can effectively be formulated, packaged, and safely administered. Expert chemists and scientists in the field agree on a handful of procedures aimed at preserving drug purity and safe self-administration.
Two compartments safely carry biopharmaceuticals to patients and doctors – the packaging material that houses all devices and the devices themselves. It’s essential all packaging materials are safe, secure, and clean.
Glass, in particular, has been scrutinized for its easily breakable nature and incompatibility with drug-related products. Appropriate alternatives are polymer-based systems, which don’t see many of the issues associated with glass. They also offer more flexibility with dose sizes and injection time, encouraging patient efficacy.
It’s also crucial all packages are clean and at low risk of contamination. Biologics are sensitive and cannot be exposed to elements that will decrease their purity. For this reason, manufacturers and regulators demand all packaging systems are meticulously inspected and assembled.
Devices Should Be Designed Diligently
Devices that administer drugs need to be expertly constructed to create a safe user experience. The emergence of highly concentrated biologics is changing the way this is done. Highly concentrated biologics pose especially complicated design questions, as their heightened potential for aggregation and viscosity makes administering drugs more difficult. The use of appropriate excipients, like silicone, are used to help mitigate viscosity, ultimately improving efficiency.
The careful construction of each compartment of the device is an essential part of this process, ultimately preventing contamination and possible health-related problems. Pre-filled syringes are effective because they can be used by the patient and provide precise single-unit dosing. They’ve been proven to be used consistently by patients who find their application straightforward. Little did they know a considerable amount of time went into engineering and testing these devices.
Every part of the device that comes into contact with the biologic must be meticulously studied to ensure contamination doesn’t occur at any time during packaging or administration. The use of silicone, for example, is used to coat the inner walls of the glass barrel of the syringe. This allows the plunger to move smoothly in the barrel, but too much silicone can contaminate the drug that rests inside the barrel. Biologic molecules are sensitive to metal ions and silicone oils, and it’s necessary to conduct complex chemical testing to ensure contamination doesn’t occur.
Careful design of all devices ensures drug effectiveness and safety. With more individuals administering highly concentrated drugs themselves, this becomes especially important, and quality analytical testing should be one of the first steps in successfully delivering biopharmaceuticals.
Early Testing for Extractables and Leachables is Necessary
As previously mentioned, a close study of a device’s interacting elements is important when preventing contamination. Extractables and leachables can migrate from interacting device components (like packaging and device compartments), lower biopharmaceutical effectiveness, and introduce unwanted leachables and contaminants into drug products. To prevent unwanted contamination, conduct early chemical testing.
All materials that come into contact with the drug must be documented and studied during the entire process of the drug’s development. Once testing is complete, scientists have a greater understanding of compatibility between drug products and their packaging. Analytical tests will vary and accommodate each unique drug and the specific type of compound.
A thorough examination of the interactions of all materials and elements ensures safety and success. Quality pharmaceutical analytical testing by a team of experts, careful device design, and smart packaging systems are some of the most important factors in effectively delivering biopharmaceuticals.