Biologics and biosimilars: the regulatory environment is a challenging area. To examine this, Tim Sandle has written a review of the current status for the journal Clean Air and Containment Review.
"The manufacture of biosimilars is complex and the processes raise quality and regulatory concerns. Of interest to readers of this journal, most biologics are prepared within cleanrooms and, due to their heat-sensitive nature, most types are aseptically filled within ISO 14644 class 5 environments", writes Dr. Sandle. "Furthermore, due to the risks associated with genetically modified microorganisms, many require special containment systems. This article considers some of the recent international regulatory issues."
To read more, see the 17th edition of Clean Air and Containment Review. Details can be found here.
Sandle, T. (2014). Biologics and biosimilars: the regulatory environment, Clean Air and Containment Review, Issue 17, pp20-21.
Posted by Tim Sandle
"The manufacture of biosimilars is complex and the processes raise quality and regulatory concerns. Of interest to readers of this journal, most biologics are prepared within cleanrooms and, due to their heat-sensitive nature, most types are aseptically filled within ISO 14644 class 5 environments", writes Dr. Sandle. "Furthermore, due to the risks associated with genetically modified microorganisms, many require special containment systems. This article considers some of the recent international regulatory issues."
To read more, see the 17th edition of Clean Air and Containment Review. Details can be found here.
Sandle, T. (2014). Biologics and biosimilars: the regulatory environment, Clean Air and Containment Review, Issue 17, pp20-21.
Posted by Tim Sandle
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