SCHOTT Pharma Solutions

Low temperature storage of mRNA

The demanding low temperature storage and transport conditions of mRNA applications put additional strain on the primary packaging system container. Cold chain conditions and the freeze-thaw cycle can impact mechanical stability, performance, container closure integrity and particulate levels. All these potential risks must be understood to launch an mRNA drug with confidence.

Drug container interaction mitigation for Biotechs

For smaller biotech companies, the right selection of drug containers is especially challenging since in-house capabilities are focused primarily on R&D and not on the selection of the optimal drug container. However, it is crucial to evaluate different primary packaging solutions early in the drug development phase to avoid stability issues such as drug-container interaction in the commercialization phase.

Improved manufacturing processes for large batches

Continuous evaluation of your manufacturing processes is essential to achieve higher drug yields using less resources. At the same time, however, high-quality standards and flexibility must be maintained. Lower cost, better quality, and higher flexibility can be contradictory goals and require a fundamental rethinking of manufacturing processes.

Delamination control

There is no single factor that causes glass delamination in a pharmaceutical setting, and it can be a difficult problem to address because it typically doesn’t show up until the product has been stored in the container for several months. Nevertheless, there are concrete steps that pharma companies can take to minimize the risk of delamination.

Drug stability for low fill volume

An increasing number of innovative drugs are filled significantly below the nominal volume of the vial. In these low-fill scenarios, the so-called heel zone has a relatively higher impact. The heel zone is a near-bottom area which might potentially show a changed leaching behavior due to an inhomogeneity caused by the standard vial converting process.

Contamination risk mitigation

SCHOTT Pharma has developed an end-to-end solution to protect the sterile integrity of its RTU portfolio: Pharma companies can order products from the SCHOTT iQ® platform with an especially designed Tyvek® bag with improved robustness and an additional visual inspection feature for perfect sealing.

Track and trace for drug containers

The advance of traceability of raw materials, parts, and finished products has been shaped by highly regulated industry sectors whose compliance is legally required, such as the pharmaceutical, aerospace, and automotive sectors. Although traceability has always been a vital aspect of pharmaceuticals production, few drug container manufacturers have taken on the challenge of actually providing traceability along the supply chain. SCHOTT Pharma sets new standards.

Identification of weak spots in fill-and-finish operations

Whether it’s a major glass breakage event or failed quality inspection, identifying where exactly issues are occurring within the manufacturing process can be difficult and resource intensive. Misaligned guardrails, process transitions, and automated handling systems can all result in excess shocks and applied pressure that can lead to damage that increases the risk of a major event during production, failed quality inspections, and breakages during shipping and transportation.