In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Podcasts|January 21, 2022
Key Considerations in Aseptic Fill Finish CMO Facilities
Author(s)Samsung Biologics
Fill finish (sterile filtration) operations are critical and often the only means to produce sterile liquid biopharmaceuticals as other means of sterilization will degrade the product(s). This complex packaging process has become more regulated and controlled in an effort to reduce the risks of contamination (with the greatest risk potential coming from cleanroom operators). This episode reviews current market trends and provides some characteristics expected of a top notch Fill Finish CMO, like Samsung Biologics in Incheon, South Korea.
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