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While the drug development team is in the process of working on the last details to optimize the drug, that is where the work for the packaging engineers really starts. A cumbersome journey of scouting and evaluation of all possible packaging options out there, followed by extensive testing and complex interpretation of the results. This process can take many months without assurance of comprehensively addressing all factors. Especially in the space of prefilled syringes which are regulated as combination products, the requirements are expansive and often ambiguous. This presentation introduces a groundbreaking innovation: An advancement in the prefillable syringe market, uniquely integrating the syringe barrel, plunger, and needle shield/tip cap into a fully harmonized, verified system from a single supplier. It will demonstrate how this system enables especially emerging biotechnology companies to significantly save time and resources, accelerating the pathway to clinical fill.

In the world of medical devices, ensuring the safety and compatibility of equipment is fundamental to patient care. Among the most significant developments in this area is the replacement of ISO 594 by ISO 80369, a series of standards redefining how medical connectors are designed and validated.

In parenteral drug development, packaging is often discussed as a format decision based on containment in vials, prefillable syringes, or cartridges. In reality, packaging choices involve far more than the container itself. Packaging influences product stability, manufacturing complexity, patient experience, and long-term lifecycle performance.
For teams entering the parenteral packaging space, the goal should not be to simply identify a “best” option. However, the goal should be to select the format that best aligns with the drug product’s characteristics, the intended patient population, and the development strategy.

Continuing our commitment to strengthening the communities where we live and work, the Bangalore GTC team recently completed another successful technology donation drive, providing refurbished laptops and other devices to schools with limited access to technology. This initiative reflects our dedication to sustainable development and demonstrates how our people can use what they do best to make a meaningful difference in empowering future generations.

Controlling particulate matter in injectable drug products has long been a cornerstone of patient safety. While large visible particles often gain public attention through recalls, subvisible particulate contamination the particles you can’t see pose an equally serious risk. These particles can compromise product quality, trigger inflammation or immune reactions, and jeopardize the safety of sensitive patient populations.

Silicone oil is commonly applied to components involved in primary drug containment, primarily serving as a lubricant for elastomeric parts. For instance, silicone oil is commonly applied to rubber stoppers and plungers to facilitate machinability throughout the fill-finish process. Similarly, it is used on the inner surface of syringes to enable smooth and controlled movement of the piston during injection. However, silicone oil introduced into the primary container may migrate into the drug product, where it can appear as sub-visible particulate matter—an important critical quality attribute (CQA) of the final drug product.