Arena W. Email and Phone Number

MST

1 Facility of Cell therapy designation and buil up2 Cell production, including ADSC, NK, CIK, CAR- etc3 processing and product design, ODM/OEM4 Biotech research

Responsibilities at R&D department 1 Clinical trial & IRB apply, CMC writing (2 cases ongoing; 2 cases mercy trial);2 GTP facility designation and setting up (layout, build monitoring,a and validation);3 Quality system and document writting, maintaining and improving (2 manuals, over 200 docs);4 ADSC isolation, cultivation and preservation (banking or therapy);5 Cell production processing improvement (master culture, package… Show more Responsibilities at R&D department 1 Clinical trial & IRB apply, CMC writing (2 cases ongoing; 2 cases mercy trial);2 GTP facility designation and setting up (layout, build monitoring,a and validation);3 Quality system and document writting, maintaining and improving (2 manuals, over 200 docs);4 ADSC isolation, cultivation and preservation (banking or therapy);5 Cell production processing improvement (master culture, package and storage); 6 Proposal and patent writing;7 Labratory and Program managing; 8 Health food ingredient development and manufacturing (2 commercial 2 pilot production). Show less

Responsibilities at R&D department 1 Set up ISO 17025 testing Lab of Medical Device Examination Lab.2 TAF accredited (testing lab#): Documented quality book, including procedure and SOPs writting.3 Major focus on sterility validation and bio-compatibility followed by ISO 11137 and ISO 10993. 4 Work on testing protocol followed by USP/EP/ANSI/JP etc. 5 Guide MD industry to follow ISO13485 and apply inspection as GMP factory.