Blogs

Our team will share their expertise and introduce several new and innovative pharmaceutical containment and closure offerings during the Paris Pharmapack trade show.

The FDA recognizes that compounded drugs serve an important role for patients whose medical needs cannot be met by FDA-approved drugs. However, compounded drugs are not approved by the FDA and therefore, have not been evaluated for safety or efficacy. Poor compounding practices or unsuitable manufacturing conditions can lead to serious adverse effects, or even patient death. Over the past few years, the FDA has taken significant steps to modernize and clarify policies related to the quality of compounding in an effort to ensure continued access to compounded drugs, while also protecting patients from the risks of contaminated or otherwise harmful products¹. FDA Draft Guidances^{2, 3} help to clarify applicable regulatory requirements and specifically address the use and handling of container closure systems.

Gene and cell therapies require cryo storage – approximately -80^oC for genes, and approximately -180^oC (i.e., vapor of liquid nitrogen) for cells. This requirement places a very high demand on the packaging to provide both good container closure integrity (CCI) and preservation of drug product viability.

The global injectable drug market sees an ever-increasing adoption of high-value biologic drug products. More than half of today’s 20 top selling injectables are biologics, and many of them are delivered in a prefilled syringe. Even though glass syringes are predominantly used for primary containment of parenterals, the (bio)pharmaceutical industry continues to cope with certain limitations associated with glass prefilled systems.

As global healthcare systems become more heavily reliant on radiopharmaceuticals for diagnostics and treatment, ensuring that the radioactive drug is safely contained for the duration of its shelf life has never been more vital.

Daikyo Crystal Zenith® container systems may be your solution!

Bisphosphonates are a class of drugs used to help prevent loss of bone density in diseases such as osteoporosis. This class inhibits increased loss of calcium from bones (bone resorption) by promoting apoptosis (elimination of cells absent release of harmful substances into surrounding area) of osteoclasts. Osteoclasts function to break down bone to assist with bone maintenance and to help balance blood calcium levels; however, in the case of patients with osteoporosis, there is an increased level of bone resorption that results in a need to manage and decrease the presence of the osteoclasts.