Tangene Group LLC

Principal:

KC Low

20 years of biologics, therapeutics protein, pharmaceutical and medical device industries experience in Quality Assurance, Quality Control, Regulatory Affairs, GLP, Clinical Trial,  ISO 9001 and 21 CFR 111 Certifications.

Successful implemented 21 CFR 820, 21 CFR 210/211,  21 CFR 111 and ISO 13485 for clients.

Awarded 10 patents and have 29 patents pending both in US and EU on biopolymer, biomaterials, protein, polyamino acid and polypeptides.

Winner of the 1996 President Green Chemistry Award.  Published 6 papers and one review chapter on protein, polyamino acids and their derivatives.

Published 6 papers and one review chapter on protein, polyamino acids and their derivatives.

Well-versed with Water, Agilent, Hitachi HPLC, RP-HPLC, IEX-HPLC, SEC-HPLC, SDS-PAGE, ELISA, LC/MS/MS, Sciex API III, API 3000, API 4000.

Method Development, validation and transfer, Data Evaluation and Validation. Bioequivalence and clinical studies of generic drugs, DPMK, Cmax, 

Successfully managed several Medical Device Products Transfer to Foreign Subsidiary or CMO.

Successfully remediated several 483 and warning letters for clients.

 

Languages:     English, Mandarin Chinese, Cantonese, Malay, Japanese (OK).

Education:  

B.Sc in Mathematics,  B.Sc  in Biology, M.Sc in Biochemistry, MBA in Management and Finance

Inventions and Patents:

US# 5,116,513: Polyaspartic Acid As A Calcium Sulfate And A Barium Sulfate Inhibitor

US# 5,152,902: Polyaspartic Acid As A Calcium Carbonate and Calcium Phosphate Inhibitor

US# 5,221,733: Manufacture of Polyaspartic Acid.

US# 5,284,512: Polyaspartic Acid and Its Salt for Dispensing Suspended Solids.

US#5,315,010: Polyaspartic Acid Having More than 50% b-form and Less than 50%  a-form

US#5,391,764: Polyaspartic Acid Manufacture

US#5,552,516: Soluble, Crosslinked Polyaspartates

US#5,612,384: Superabsorbing Polymeric Networks

US#5,847,013: Superabsorbing Polymeric Networks

EP#530,358: Polyaspartic acid As A Calcium Carbonate and Calcium Phosphate Inhibitor

EP#530,359: Polyaspartic Acid As A Calcium Sulfate And A Barium Sulfate Inhibitor

AWARDS AND HONORS:

1996    President Green Chemistry Award