BME 695L Lecture 15: GMP and Issues of Quality Control Manufacture of Nanodelivery Systems

See references below for related reading.15.1      Overview15.1.1    What does cGMP mean?15.1.2    Why GMP? Controlling processes means more predictable outcomes…15.1.3    Enforcement15.1.4    What can be learned from the semi-conductor industry clean-room and manufacturing?15.1.5    What doesn’t fit this paradigm?15.2      cGMP-level manufacturing15.2.1    Predictable methods lead to predictable products15.2.2    The CFR (Code of Federal Regulations) sections on GMPs15.2.3    What is covered under cGMP?15.3      Bionanomanufacturing15.3.1    So what is special about biomanufacturing?15.3.2    Nano-clean water necessary for nano-pharmaceuticals15.3.3    Contaminants at the nano-level15.3.4    Can you scale up the process?15.4      Some quality control issues – how to test15.4.1    Correctness of size – size matters!15.4.2    Composition – atomic level analyses15.4.3    Monodispersity versus agglomeration15.4.4    Order and correctness of layers215.4.5    Correctness of zeta potentials15.4.6    Does the nanomedical system contain the correct payload?15.4.7    Targeting (and mis-targeting) specificity and sensitivity