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

Digital solutions are key for enhanced inventory management and patient safety in hospital environments. At the same time, product integrity has to be ensured until the point of use. Schreiner MediPharm’s Cap-Lock Label with RFID functionality enables digital tracking of prefilled syringes on unit level as well as enhanced efficiencies along the supply chain.

The new Cap-Lock plus RFID is based on the proven principle of Schreiner MediPharm’s Cap-Lock Label and is combined with SCHOTT Pharma’s SCHOTT TOPPAC^® infuse COC syringes. Thanks to a special cap design that has the same diameter as the syringe barrel, the Cap-Lock Label wraps around the syringe and cap. A label-integrated irreversible first-opening indication is activated as soon as the cap is opened. The solution safeguards the integrity of the prefilled syringe until final use, thus replacing the usual blister pack by a sustainable alternative enabling considerable CO₂ reductions and cost savings. Additionally, due to optimized packaging and distribution processes as well as reduced space requirements during transportation and storage, it helps enhance efficiencies along the entire supply chain.

The special innovation of Schreiner MediPharm’s Cap-Lock plus RFID is its integrated RFID functionality. In addition to the analog first-opening indication, the chip embedded in the label offers a digital first-opening indication. In hospital settings, this enables automated tracking of the integrity of each individual prefilled syringe—up until the medication is administered. Consequently, there is no need to manually check if the syringe has previously been opened, resulting in optimized and reliable processes for healthcare staff. At the same time, clear identification on unit level is supported, which makes seamless tracking in the supply chain possible and facilitates automated inventory management in daily hospital settings. Expired drugs are automatically detected and unused prefilled syringes can be returned to inventory in a reliable process. Potential diversions and medication misuse can be monitored digitally.

Like all RFID solutions from MediPharm, the new Cap-Lock plus RFID features a particularly robust design. A special label construction reliably protects the integrated chip against mechanical stress and functional failure—even on the high-speed dispensing systems in pharmaceutical manufacturing. Thus, the readability and functional reliability of the label-integrated RFID chip is guaranteed from production to final use. As a result, pharmaceutical companies are provided with a reliable solution avoiding additional costs due to production downtimes and waste rates. At the same time, product and patient safety is enhanced.

Light-sensitive substances such as biologics or biosimilars react sensitively to UV and light rays—which may impair their efficacy and shelf life. Schreiner MediPharm meets this challenge with innovative light protection labels that not only protect the sensitive substances but also enhance safety and efficiency when using prefilled syringes.

Prefilled syringes have become an integral part of everyday medical practice due to their ease and speed of use by healthcare staff and patients. However, the transparency of glass or COC poses a risk to light-sensitive drugs: UV and light rays can impair the active ingredients. That’s why Schreiner MediPharm offers customized light protection solutions that are suitable for all commonly used types and sizes of syringes—whether with needles or Luer-lock adapters.

The new functional labels from Schreiner MediPharm are available in three light protection levels covering various requirements. While Level 1 offers UV protection as well as allowing transparency thanks to an integrated inspection window, Level 2 additionally protects against blue light–but still allows to see the fill level due to a semi-transparent window. For maximum safety, Level 3 offers full light protection. If necessary, resealable inspection windows may be integrated to check the syringe content in its original color.

The light protection can be integrated in three different types of labels meeting the individual requirements of pharmaceutical companies with a variety of functions. The Light-Protect-Label covers the syringe barrel while the Syringe-Closure-Wrap Label wraps around the syringe barrel and cap, which increases the light protection and has a first-opening indication feature as well. The Cap-Lock Label has been designed specifically for the SCHOTT TOPPAC^® infuse syringe and also combines increased light protection with first-opening indication. Additional features such as graduations and documentation labels may be integrated too. Thus, the new light protection labels combine protection, functionality, and efficiency—for more safety and reliability when using light-sensitive substances.

Schreiner MediPharm together with SCHOTT Pharma and Körber Pharma has developed an innovative packaging concept for prefilled syringes requiring no blister packaging. The new solution offers numerous benefits in terms of sustainability, security, and cost efficiency and met with strong interest at this year’s Pharmapack in Paris. The three partners are thus emphasizing their pioneering role in the field of pharmaceutical packaging.

The blister-free concept is based on the combination of a SCHOTT TOPPAC^® infuse COC syringe with an innovative specialty cap and the novel Cap-Lock Label from Schreiner MediPharm. Due to the new cap design, which has the same diameter as the syringe barrel, the Cap-Lock Label can be applied to the syringe barrel and cap in a reliable process, enabling tamper-evident first-opening indication. Opening the cap irreversibly damages the label so that users immediately see if the syringe has been opened before. “With this solution, we ensure maximum product safety and integrity—from manufacturing to final use,” explains Dr. Nadine Lampka, Senior Product Manager Pharma-Security at Schreiner MediPharm.

Moreover, the Cap-Lock Label performs other protective functions of the conventional blister and transfers them to the primary container. For instance, it can include a gas barrier and multi-level UV and light protection ensuring the stability of the active ingredients. In addition, the extended label area provides ample space for individual product markings and color codes. The integration of an RFID chip for automated tracking on unit level and for digital first-opening indication are possible as well. The combination of a COC syringe with a special cap and functional label with a seal function enables the utilization of a volume-optimized top-load cardboard box from Körber Pharma consisting of 100 percent mono-material. That optimizes packaging and distribution processes in pharmaceutical manufacturing and clearly reduces the space required for transportation and storage.

The new concept offers considerable economic benefits for pharmaceutical manufacturers—while clearly enhancing sustainability. The space-saving packaging reduces material consumption and enables more efficient logistics. “Due to eliminating the need for blister packaging, we can reduce plastics and plastics waste by up to 80 percent and significantly increase transportation capacity at the same time,” emphasizes Christoph Zauner, Head of Global Product Management for Polymer Solutions at SCHOTT Pharma. A sample calculation shows that the number of containers for one shipment of ten million 5 ml SCHOTT TOPPAC^® infuse syringes from Hamburg to New York can be reduced by 16 while avoiding around 87,400 kilograms of CO₂ emissions.

At Pharmapack, the three partner firms presented the solution as part of the Alliance to Zero Workshop “How to Build Sustainable Value Chains Together”. Lidia Smith, Sustainability and Product Manager at Körber Pharma, emphasizes, “The great response at the trade fair shows that sustainable packaging concepts are urgently needed. Our collaboration with Schreiner MediPharm and SCHOTT Pharma is an important step toward an eco-friendlier pharma supply chain.” Schreiner MediPharm underscores its commitment to innovative, sustainable solutions with further functional labels for pre-filled syringes including Needle-Trap Secu and Syringe-Closure-Wrap, both of which enable secure, blister-free packaging as well.

In a current clinical trial for a novel antibody drug conjugate (ADC), a specialty Light-Protect-Label from Schreiner MediPharm is used. It reliably protects not only the light-sensitive active ingredient but also enables an inspection of the vial content in the original color. In addition, it neutralizes the investigational drugs within the clinical trial.

Antibody drug conjugates are an important innovation in cancer therapy. Through targeted delivery of drugs into specific tumor cells they enable gentler and more effective treatment compared to conventional chemotherapies. This technology acts directly on the cancer cell, thus largely sparing healthy cells and minimizing side effects.

WuXi XDC is a leading contract research, development, and manufacturing organization (CRDMO) headquartered in China with a focus on the global ADC and bioconjugate market. To support a biotech company in a clinical trial for an ADC drug, WuXi XDC required a reliable label solution. Because the light-sensitive active ingredient is filled into vials as a lyophilized powder, effective protection against external influences was necessary. WuXi XDC found the most suitable solution through the cooperation with Schreiner MediPharm by implementing a Light-Protect-Label that perfectly met the specific customer requirements.

Schreiner MediPharm developed a solution with integrated UV and light protection that is suitable for transparent vials. The opaque label completely wraps around the container and offers optimal protection while a resealable inspection window enables an unadulterated view of the content. That is crucial for inspecting the condition and color of the reconstituted lyophilisate before it is administered and to thus ensure the efficacy of the medication. At the same time, the label from Schreiner MediPharm supports a dependable and safe conduct of the clinical trial by reliably blinding the investigational drugs. Hence WuXi XDC benefits from an efficient, multi-functional solution combining the protection of the light-sensitive active ingredient with reliable blinding during the clinical trial. This optimizes processes, accelerates trial workflow, and supports product and patient safety.

Novel therapies and vaccines based on mRNA substances as well as cell and gene therapies are becoming increasingly important , but these active pharmaceutical ingredients (APIs) are particularly sensitive. They are stored and transported on dry ice at temperatures of down to -100 °C. In addition, many APIs must be protected against light. For these applications, Schreiner MediPharm has developed the novel Freeze-Light-Protect syringe label.

Ever since the coronavirus pandemic mRNA substances not only have been on everyone’s lips but the exacting requirements to be met in transportation and storage have also become common knowledge. The Freeze-Light-Protect label from Schreiner MediPharm addresses exactly these challenges. The marking label reliably adheres to the syringe even at low sub-zero temperatures. In addition, the label can be equipped with a variety of UV and light protection levels: from pure UV protection to protection against UV rays and blue light to complete light protection—depending on the customer’s requirement.

The innovative label from Schreiner MediPharm was developed in coordination with its partner SCHOTT Pharma that introduced the matching syringe on the market: SCHOTT TOPPAC® freeze. The 1 m long COC syringe is designed for drugs at temperatures as low as -100 °C with a focus on retaining reliable syringe functionality as well as syringe closure integrity and thus ensure drug stability. Freeze-Light-Protect was tested specifically for the SCHOTT TOPPAC® freeze syringe to document the reliability of the label-integrated protective functions and to underscore product and patient safety.

Moreover, additional functionalities can be integrated in the label from Schreiner MediPharm: detachable documentation labels for vaccination certificates or patients’ medical records, inspection windows for checking the syringe content in true color, and a graduation for correct dosing when performing the injection. With the combination of Freeze-Light-Protect and SCHOTT TOPPAC® freeze, pharmaceutical companies are provided with a prequalified solution that can be customized according to their specific application—thanks to the concentrated expertise of Schreiner MediPharm and SCHOTT Pharma.

Specialty glass manufacturer SCHOTT AG and pharma label expert Schreiner MediPharm have been engaged in an intensive partnership for several years. Its objective is the development of solution concepts enabling a wider use of polymer syringes in the pharmaceutical sector. Based on extensive tests, a large number of functional label designs have been developed that can compensate the specific properties of polymer against glass. The continuation of this collaboration is now focused on market trends such as connectivity using RFID or cryogenic applications that are relevant especially in the context of COVID-19 and mRNA vaccines.

The pharmaceutical industry is increasingly using polymer syringes made of COC/COP (cyclo-olefin copolymers/cyclo-olefin polymers) materials. Their advantages over glass containers include break resistance, lower weight, less protein adsorption, and design flexibility. However, they also have certain disadvantages: their barrier properties are reduced and they have no UV and light protection, which may be critical in the case of sensitive substances such as biologics/biosimilars, cell and gene therapies, or mRNA-based vaccines and medications.

Currently, mRNA vaccines against COVID-19 are filled in multi-dose vials. However, when the coronavirus pandemic becomes endemic it may be more advantageous to package the vaccine in prefilled single-dose syringes. They can be stored for clearly longer periods of time than multi-dose vials whose contents must be used shortly after opening. In addition, single-dose syringes generally offer more efficient handling compared to a multi-stage process when a substance has to be removed from a multi-dose container. Due to the high sensitivity of mRNA vaccines, they have to be transported and stored at cryogenic temperatures. Consequently, reliable adhesion of the functional marking label to the syringe is particularly important.

The two specialized companies demonstrated in extensive tests that functional labels can optimally complement polymer syringes. For instance, a multi-layered label can decisively reduce the oxygen diffusion of the syringe, multi-stage label concepts for UV and light protection can help protect sensitive substances against harmful rays, and low-migration labels can mitigate the risk of migration in the case of plastic containers.

“The solution concepts jointly developed by Schreiner MediPharm und SCHOTT for COC/COP syringes are ideally suited for sensitive substances and adapted precisely to the respective requirement. They are focused on product and patient safety, and easy integration into the pharmaceutical production process,” says Tom Van Ginneken, Head of Global Product Management for SCHOTT TOPPAC®.

UV light lifts our spirit, enhances our immune response, and helps us produce vitamin D—a totally positive effect for the human body. However, UV radiation may have a damaging impact on some active pharmaceutical ingredients (APIs) because they may lose their efficacy due to light irradiation. Micafungin is a case in point. For this highly light-sensitive medication, Schreiner MediPharm developed a special light protection solution—with integrated UV protection and a clever inspection feature.

Micafungin is an antimycotic agent, a medication that is used to treat and prevent invasive fungal infections. The API is filled into vials as a lyophilized powder and serves as a concentrate for infusion solutions. However, transparent glass containers pose special challenges to pharmaceutical manufacturers: they offer no light protection and the medication might be damaged by exposure to light.

With Light Protection Labels specifically designed for the sensitive Micafungin drugs, Schreiner MediPharm offers marking solutions enabling enhanced API protection against UV radiation and light. Each label design is customized to suit the particular container and to meet the product’s specific light and light protection requirements. Examples of available options include a label using an opaque material that delivers full protection against light in the covered areas. The vial content can be checked through a resealable inspection window (see picture of Light Protection Level 3). Other design versions for visual inspection are label-integrated transparent or resealable, semi-transparent colored windows that can also offer enhanced protection against UV rays and blue light (see pictures of Light Protection Levels 1 and 2).

The development of reliable labels for vials containing light-sensitive active ingredients requires in-depth know-how of materials, adhesives, and printing technologies. As an expert in high-grade functional labels Schreiner Medi-Pharm can additionally draw on extensive tests of light protection properties to design customized and application-specific solutions.

Beauty is a subject that has always played a major role in the world’s diverse cultures over the centuries. Today, the question of personal beauty has greater relevance than ever before and is reinforced by the power of pictures and social media: In 2019, 25 million cosmetic procedures were performed worldwide — and the trend is rising. More than 4.3 million of them were wrinkle treatments with hyaluronic acid injections. Plastic syringes are increasingly used to administer them in cosmetic medicine. For ease of use, optimal marking, and reliable tamper protection, Schreiner MediPharm offers a wide variety of labels with value-adding functions for cosmeceuticals syringes.

Cosmetic surgery is a growth market. More and more people are trying to counteract the natural skin aging process by means of aesthetic injections. For facial wrinkle treatments, injections of so-called dermal fillers are used. They include hyaluronic acid, a gel with particularly high viscosity. The thinner the syringe used for the injection, the smaller the physical exertion required by the cosmetic surgeon. Polymer syringes have a number of advantages over glass syringes, such as higher break resistance, lower weight, and greater custom-design flexibility. However, prefilled COC syringes have limited migration properties. In addition, tamper protection poses a challenge.

For cosmeceuticals syringes, Schreiner MediPharm offers a wide variety of customized functional labels that simplify handling, enhance tamper protection, and compensate for material deficits. The label design, for instance, can incorporate precision graduations such as milliliter markings and dosing units for exact injection dosing. Tamper-evident and first-opening indication solutions such as the new Syringe-Closure-Wrap for sealing prefilled syringes protect the integrity of the syringe. For product and brand protection, overt, covert, and digital authentication features can be integrated into the label. They enable authentication along the supply chain—from laypersons to informed experts—depending on the security level.

In addition, Schreiner MediPharm offers suitable solutions such as the multi-layered Pharma-Comb ILSC label for attaching comprehensive product information to cosmeceuticals syringes with their narrow syringe radii. The label is wrapped tightly around the syringe, can be opened and closed again easily, and is additionally equipped with detachable documentation labels.

Low-migration labels can be adapted precisely to the respective application using pre-qualified materials, which clearly minimize the risk of migration that polymer syringes entail. Schreiner MediPharm can draw on comprehensive outcomes of studies involving low-migration adhesives, materials, and inks, and provide customer-specific advice.

The functional, customized syringe labels for cosmeceuticals provide manufacturers of cosmetic medicine products with solutions ensuring process reliability, flexibility, and smooth production processing, while supporting injection comfort and safety, and protecting patients.

Acute care encompasses all emergency medical services—from first aid, rescue ambulance services, admission to the emergency room and surgery, to treatment in intensive care units. In all of these settings, medications have to be administered as efficiently as possible without jeopardizing the patient’s safety due to potential medication errors. Equally important is a transparent and reliable hospital supply chain ensuring that the right medicine is available at the right time.

Several trends are emerging in this context: Prefilled syringes are increasingly being used instead of vials to enable fast injections. Modern, high-grade COC/COP syringes are progressively replacing disposable plastic syringes. More and more automated RFID-based inventory management systems are rolled out for simplified administration and reliable processes.

To enable pharmaceutical manufacturers to satisfy these acute care requirements, Schreiner MediPharm offers functional labels and marking solutions with analog and digital features specifically for emergency medicine uses.

All solutions are customized to suit the relevant acute care application—so that medications are administered fast and safely to emergency and intensive care patients.