Aseptic filling of unstable drug products

Sometimes the best therapies are hard to manufacture. When a drug product is unstable (e.g. light sensitive, shear-sensitive, temperature-sensitive), formulation and sterile filling become increasingly more complex.

In this webinar, we discuss what a typical fill finish process looks like, how this may affect your unstable drug product, and techniques to protect your product during formulation, filling, storage, and distribution. We review several common drug product sensitivities and outline solutions to protect your drug product.

00:00 - Intro
01:07 - A typical fill finish process
06:56 - Fill finish overview
08:13 - Drug product sensitivities
08:30 - Light sensitivity
12:10 - Temperature sensitivity
17:23 - Lyophilization
19:34 - Shear sensitivity
22:50 - Sensitive drug product overview
24:08 - Packaging, Labeling, & Distribution
30:11 - Transition Q&A
31:19 - Q&A
36:15 - Conclusion

[jamesmackenzie]

I'm not new in the Pharmaceutical industry having worked in OSD for almost 30 years, but I am new in parenterals. This Webinar was super helpful. Thank you.