BME 695N Lecture 20: GMP and issues of quality control manufacture of nanodelivery systems

Outline:Overview What does cGMP mean? Why GMP? Controlling processes means more predictable outcomes… Enforcement What can be learned from the semi-conductor industry clean-room and manufacturing? What doesn’t fit this paradigm?cGMP-level manufacturing Predictable methods lead to predictable products The CFR (Code of Federal Regulations) sections on GMPs What is covered under cGMP?Bionanomanufacturing So what is special about biomanufacturing? Nano-clean water necessary for nano-pharmaceuticals Contaminants at the nano-level Can you scale up the process?Some quality control issues – how to test Correctness of size – size matters! Composition – atomic level analyses Monodispersity versus agglomeration Order and correctness of layers Correctness of zeta potentials Does the nanomedical system contain the correct payload? Targeting (and mis-targeting) specificity and sensitivity