Modern medicines such as mRNA-based vaccines or biologics place new demands on pharmaceutical packaging. In addition to extreme sub-zero temperatures, light and oxygen are potential risk factors for the stability of the active ingredients contained. Functional labelling solutions can offer effective protection.
The pharmaceutical industry is undergoing fundamental change. In addition to traditional active ingredients, novel forms of therapy and drugs such as mRNA technology, cell and gene therapies as well as biologics and biosimilars are becoming increasingly important. mRNA technology became known worldwide in particular through COVID-19 vaccines. However, its potential extends far beyond the pandemic: mRNA-based medications are also being researched for cancer, autoimmune diseases and heart failure. Equally revolutionary are biologics, genetically engineered drugs that are usually based on complex protein structures. Like the biosimilars based on them, they are primarily used in the treatment of serious diseases such as rheumatism, Crohn's disease or tumours.
Functional labels for critical challenges
As promising as these active ingredients are: They are characterised by their high sensitivity to external influences. Many modern drugs, especially mRNA or cell therapeutics, have to be transported and stored on dry ice. In addition, many of these active ingredients are sensitive to light. Transparent glass or plastic containers do not offer sufficient protection: They must therefore be additionally shielded against UV and light rays. Another critical factor is oxygen: biologics and biosimilars in particular are susceptible to oxidation. Contact with oxygen can trigger chemical reactions that impair the active ingredient.
These challenges cannot be solved by primary packaging alone. Functional labels that are customised to the medicine, the primary container and the application are becoming increasingly important here. In addition to classic product labelling, such labels can offer UV and light protection as well as a gas barrier function to prevent oxygen diffusion.
„The decisive factor here is customisation to the respective active ingredient, the vessel and the process. In-depth knowledge of materials, laboratory-based development work, extensive testing and close cooperation with the respective pharmaceutical customer result in solutions that not only protect, but also optimise processes and support patient safety.“
Corinna Endres, Product Manager Drug Protection at Schreiner MediPharm
Light protection solutions for various applications
The safe use of light-sensitive active ingredients places high demands on the primary packaging. Transparent glass or plastic offer hardly any protection against UV or light rays. These factors can lead to molecular degradation, particularly in the case of sensitive substances. Schreiner MediPharm has therefore developed multi-stage light protection solutions that are customised to the active ingredient and primary packaging.
These functional labels are available in different levels of protection. Level 1, for example, combines protection against UV rays with a transparent viewing window that enables visual inspection of the medication. Level 2 extends this protection to the visible blue light range: a wavelength that can also cause relevant reactions in the active ingredient. A resealable, semi-transparent inspection window allows the contents of the container to be viewed. Level 3 offers comprehensive protection for active pharmaceutical ingredients (APIs) that are sensitive to the entire visible light spectrum. The container is almost completely enclosed by an opaque label, which is also equipped with a resealable inspection window.
An illustrative example is the active ingredient micafungin, which is filled into vials as a freeze-dried powder. The challenge: the active ingredient is light-sensitive. Vials made of amber glass are often used, but these do not allow the contents to be checked in their original colour. In contrast, Schreiner MediPharm's labelling solution is especially suitable for vials made of transparent glass and offers complete light protection as well as a resealable inspection window. This enables healthcare professionals to reliably visually inspect the contents, thereby increasing patient safety.
Clinical studies and blinding
Clinical trials play a central role in drug development. Here it is essential that light-sensitive investigational medicinal products are not only protected from light, but also reliably blinded. This ensures that placebo and verum are reliably neutralised.
A real-life example from practice is the use of a specially developed label from Schreiner MediPharm for a clinical trial with an antibody drug conjugate (ADC) for WuXi XDC, a leading contract research, development and manufacturing organisation (CRDMO) headquartered in China. The conjugate was filled into vials and had to be protected from UV and visible light as well as completely blinded. An opaque functional label with an integrated light protection function was used. At the same time, a resealable viewing window was integrated into the label design to enable reliable visual inspection of the vial contents.
Combined solutions for syringe applications
Multi-level light protection labels enable pharmaceutical companies to efficiently equip their prefilled syringes with customised UV and light protection. The new functional labels from Schreiner MediPharm are suitable for all common syringe types and sizes, whether with a needle or Luer lock adapter: They are individually adapted to the respective glass or COC (cyclo-olefin copolymer) syringe and can be processed without heat. This means they can also be used for syringes with temperature-sensitive contents.
Many innovative active ingredients, particularly in the field of mRNA and cell therapy, require Storage at extremely low temperatures. This poses particular challenges for labelling. Labels must adhere reliably at temperatures as low as -196 °C, remain legible and retain their function even after thawing.
The company has developed the Freeze-Light-Protect syringe label precisely for such applications. The label was realised in coordination with partner Schott Pharma specifically for its Toppac freeze-COC syringe, which is suitable for temperatures down to -100 °C. The label adheres reliably even at these sub-zero temperatures. It adheres reliably even at these sub-zero temperatures and also offers multi-level protection against UV and light rays, inspection windows and the option of integrating additional functions such as graduations for precise injection dosing and removable documentation parts.
Barrier against oxygen
A critical aspect in the packaging of biotechnological drugs is protection against oxygen diffusion. Especially with polymer-based COC syringes, which are characterised by their low weight and break resistance, the barrier to gases is lower compared to glass. This can be a challenge for sensitive active ingredients such as biologics, which can become chemically unstable even with small amounts of oxygen.
In order to safely protect these active ingredients Label with gas barrier developed. These consist of specially selected and qualified materials that significantly reduce oxygen diffusion. Different variants are available: For example, a solution that covers the syringe body over a large area, as well as a more comprehensive solution: the Syringe Closure Wrap also encloses the entire cap and is sealed at the upper end. It also contains an irreversible first-opening indicator to increase tamper protection.
packaging journal 3/2025
