Our fully loaded analytical/quality control lab features the following:
- Performs all product release testings except NMR (31PNMR, 13CNMR and 1HNMR done in CAS center)
- A new NMR will be installed in new facility M2 in 2013
- Analytical method research and development
- Method validation and transfer
- Stability studies including accelerated stability studies for all in-house products and the custom synthesis products
- Typical analytical instruments are HPLC for product ID, purity and assay; LC/MS for molecular mass; GC for residual solvents; UV for purity; KF for moisture content; AA for heavy metal analysis; Turbidimeter for solution clarity; bacterial endotoxin analysis, etc.
- Impurity isolation, synthesis and structure elucidation
- Provides formal CoA for each lot of product manufactured
State of the Art
Hongene has its own IP of enzymatic bioconversion technologies for more than 60% of its in-house products or processes. Below is a comparison of our process versus a more traditional method.
Chemical Synthesis using traditional nucleoside chemistry:
Enzymatic Bioconversion (aka. green chemistry):
Our system for quality includes quality assurance, quality control and regulatoryIP services.
Of our two manufacturing facilities the first (M1) is ISO 9001 certified. The second (M2) was built per GMP standard and will be GMP certified by the SFDA in 2014.
We offer a fully loaded Analytical/QC lab and a conprehensive documention system.
Audits and Customer Satisfaction
Each year we undergo multiple quality audits and vendor qualification audits from companies in US and Europe as well as our own periodic, internal quality audit programs.
We've received the best customer satisfactory survey results from several internationally well-known companies (98/100 perfect score on quality, delivery time, documentation, and services).