Quality Alchemist (品質煉金術師): CUBIC Life Science Group Tea Gathering

2016年4月18日星期一

CUBIC Life Science Group Tea Gathering – Pharmaceutical & Nutraceutical Industry

I was invited by Dr. Victor Lau (Technology Transfer Officer, KTO, CityU) to join CityU Business & Industrial Club (CUBIC) Happy Hour Tea Gathering from Life Science Group on 18 April 2016. I would like to summarize the talk as follows.

Dr. Herman C. Lam (CEO, Powder Pharma Coating Inc.) was the guest speaker and his topic entitled “From Rainforest to Desert: Commercialization of the revolutionary electrostatic dry powder coating technology for pharmaceutical and nutraceutical industries”. Dr. Lam said Powder Pharma Coating would be the next generation of coating technology for pharmaceutical R&D and manufacturing to replace traditional aqueous and solvent coating processes.

Firstly, Dr. Lam briefed why tablets, capsules, beads and pellets need coating. Because it could improve appearance, compliance, physical and chemical stability, ease of packaging and to swallow, etc. However, the existing technique using liquid coating had the following disadvantages:

- Microbial contaminations in aqueous coating processes

- High energy cost and expensive air handling systems

- Water sensitive products

- Batch-to-batch variations for functional coatings

- Product stability issues

- Long processing time, etc.

The comparison of cost between Powder and Solvent coating was shown in the following table.

Then Dr. Lam briefed the timeline of their product development. They would establish the product development and GMP manufacturing facility in Toronto, Canada.

The technology trend from sugar coating to solvent coating to aqueous coating and finally to powder coating was discussed.

Finally, Dr. Lam mentioned the cGMP and FDA title 21 CFR Part 11 – Electronic Records and Electronic Signatures. He said Validation was most important and Reliable Results were based on Method Validation, Calibrated Instrument and Training. He also introduced his two CVG books for further reference.