Regardless of a company’s size, recognizing the importance of packaging development and prioritizing its role in drug development early on can help you proactively identify events that could delay your timelines and prepare you to develop strategies to overcome the risks.
Review dynamics in bringing an injectable biologic to market and the top challenges that emerging companies face. Gain solutions on how to set up your company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.
To meet regulatory expectations, the mindset around E/L testing must change from “How quickly can we get extractable and leachables testing done?” to “Is it too soon to start?” Learn what you need to know about planning for your E/L testing programs to mitigate delays to your drug development timelines.
A growing biopharma company outsourced its fill finish operations to a CMO that made all decisions regarding component selection for container closure systems. The company discovered the lyophilization stopper was contributing to several operational inefficiencies, and they were willing to do the requalification work required to make a change in the stopper selection.
Learn more about a biotechnology company with a recently approved gene therapy product that partnered with West to select a packaging solution that would allow them to meet their needs for storage at low temperatures and still get to market quickly.
This study was conducted in four separate experiments to explore the influences of capping force, cooling rate, dimensional changes, and long-term storage at -80°C on the vial-stopper-seal combination’s ability to maintain closure integrity.