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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