Hello
Could you kindly share how would you calculare MACO for biological products for product changeover cleaning in bioreactors?
Hello Mr Varma,
“Establishment of limit for biotech actives” is discussed in PDA tech report #49 (Points to Consider for Biotechnology Cleaning Validation) under section 4.1.
You can use toxicity data or 1/1000th of minimum therapeutic dose concept for limit setting. if you could demonstrate that your deactivation process can completely destruct your protein (or active ingredient in previous product), no need to set any limit and need to prove the absence of the residue in 3 runs, with best sensitive analytical techniques.