Biologics, mRNA therapies, antibody drug conjugates (ADCs) as anticancer drugs, and other novel pharmaceuticals are highly effective—but equally sensitive. Reliably protecting them requires more than just suitable primary packaging. At Schreiner MediPharm, Corinna Endres, Product Manager Drug Protection, oversees tailored label solutions with protective functions such as light protection and gas barriers or that are suitable for deep-freeze applications. In an interview, she provides insights into current challenges and innovations in the field of drug protection.

Corinna, what challenges do modern active ingredients (APIs) such as biologics or mRNA drugs entail for packaging?

Many of these APIs react extremely sensitively to external influences such as light, oxygen, or temperature. That makes packaging them a complex matter. Especially in the case of transparent containers, or COC syringes, which offer many advantages but have a lower barrier effect against oxygen, additional protection is required. The objective is to ensure the stability and effectiveness of a drug—without limiting the functionality or visual inspection of the container. Especially with highly sensitive drugs, that’s often a balancing act.

One of the focal topics is light protection. What solutions do you offer for that?

Our light protection solutions are based on a modular concept—depending on the sensitivity of the API. There are three protection levels: from UV protection with a transparent inspection window to full light protection with a resealable inspection window. These protection levels can be integrated into various label types. The Light-Protect-Label, for instance, offers customized UV and light protection for vials or syringes. The Syringe- Closure-Wrap Label wraps around the syringe barrel and cap and is equipped with a first-opening indication feature. For light protection of larger syringes, we’ve developed the Cap-Lock Label that envelops the barrel and cap combined with a sealing function.

What about temperature stability—in the case of mRNA drugs, for instance?

Deep-freezing plays an increasingly important role. Many mRNA or cell and gene based drugs are stored at -80 °C or even lower temperatures. For those requirements, we’ve developed the Freeze-Light-Protect Label. It reliably adheres to the container even at extreme sub-zero temperatures and can be combined with various light protection levels and other functions such as graduations or documentation labels.

And how can protection against oxygen be enhanced?

That’s where our labels with an integrated gas barrier come into play. They significantly reduce oxygen diffusion—an important issue especially with COC syringes. We offer variants that either cover a large area of the syringe barrel or, in the form of Syringe-Closure-Wrap, enclose the cap as well. The latter variant additionally includes an irreversible first-opening indication for tamper evidence.

Detailed information can be found on our Drug Protection product page: www.drug-protect-label.com