Open AccessProcess analytical technology ( PAT ) tools for the cultivation step in biopharmaceutical production
Author(s) -
Streefland Mathieu,
Martens Dirk E.,
Beuvery E. Coen,
Wijffels René H.
Publication year - 2013
Publication title -
engineering in life sciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.547
H-Index - 57
eISSN - 1618-2863
pISSN - 1618-0240
DOI - 10.1002/elsc.201200025
Subject(s) - biopharmaceutical , process analytical technology , quality by design , biochemical engineering , process (computing) , microbiology and biotechnology , engineering , quality (philosophy) , automation , computer science , manufacturing engineering , work in process , biology , operations management , mechanical engineering , downstream (manufacturing) , philosophy , epistemology , operating system
The process analytical technology ( PAT ) initiative is now 10 years old. This has resulted in the development of many tools and software packages dedicated to PAT application on pharmaceutical processes. However, most applications are restricted to small molecule drugs, mainly for the relatively simple process steps like drying or tableting where only a limited number of parameters need to be controlled. A big challenge for PAT still lies in applications for biopharmaceuticals and then especially in the cultivation process step, where the quality of a biopharmaceutical product is largely determined. This review gives an overview of the currently available tools for monitoring and controlling the biopharmaceutical cultivation step and of the main challenges for the most common cell platforms (i.e. Escherichia coli , yeast, and mammalian cells) used in biopharmaceutical manufacturing. The real challenge is to understand how intracellular mechanisms (from synthesis to excretion) influence the quality of biopharmaceuticals and how these mechanisms can be monitored and controlled to yield the desired end product quality. Modern “omics” tools and advanced process analyzers have opened up the way for PAT applications for the biopharmaceutical cultivation process step.