BME 695N Lecture 20: GMP and issues of quality control manufacture of nanodelivery systems
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Abstract
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
References
- CFR (Code of Federal Regulations) sections on GMPs.
http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200421
Go into the "Browse Parts" column and select Parts 200-299. The GMP sections are 210 and 211.
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Time
Location
Biomedical Engineering Building, Rm 1083