Blogs

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.

John Rech

March 31, 2026

In the rapidly evolving landscape of drug delivery, on-body delivery systems (OBDS) continue to stand out as a sophisticated integration of medical devices and pharmaceuticals, collectively referred to as "combination products." These devices provide unique benefits that allow patients to administer large volumes of medicine in the comfort of their home. The additional benefit of a pre-programed OBDS allows for drug administration at predetermined times and dosages with minimal user intervention, thereby supporting patient adherence and, by extension, supporting clinical outcomes.

Di Wu and Cate Vora

March 25, 2026

Contamination control is the cornerstone of sterile drug product manufacturing. As therapies become more complex and patient safety expectations rise, regulators and standards-setting bodies are sharpening their focus on holistic contamination control strategies. When the European Union, World Health Organization (WHO) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised the GMP Annex 1 guidelines for sterile medicinal products, it raised the bar on expectations of manufacturers and their sterile product suppliers, by extension. Since the publication date, several other global jurisdictions have adopted these guidelines into their national law or developed complementary requirements.

Lauren Orme

March 11, 2026

In the complex world of pharmaceutical development, drug developers have a lot to think about. From formulation and testing to containment and delivery, every decision carries risk, cost, and long-term implications. Making these decisions can be overwhelming in and of itself — but when you consider that the timing of each choice can influence the overall drug timeline, the challenge intensifies. These complexities call for a forward-thinking approach — one that considers not just today’s choices, but the ripple effects they create across the entire drug product lifecycle.
That’s why it’s critical not just to make the right decisions for the moment, but the smart ones that enable a successful launch — and, more importantly, ensure the long-term success and sustainability of your drug product.

Haley Johnson

March 03, 2026