Transcript
regenerative medicine research
Regenerative Medicine
Procedure for GMP Manufacturing Facility Use
GMP Equipment and Quality System
Location
the development of advanced therapy medicinal
products in regenerative healthcare fields
· Verified safety and efficacy of products at GLP facilities
· Completed the GMP manufacturing process and
analytical methods
nine (9) months
finishing manufacturing of products
· Ripple Effect of Regenerative Medicine
Fees of Service Minimum price to reduce the cost burden of users
http://nih.go.kr/ncsr
Cheongju-si, Chungcheongbuk-do, 28160, Korea
TEL . +82-43-249-2533
FAX . +82-43-249-2548
And Regenerative Medicine
Division of Intractable Disease Research
e-mail [email protected]
Phone +82-43-249-2533
researcher's investigation cell therapy drug for clinical
phase 1 or phase 1/2a
National Institute of Health Republic of Korea
National Institute of Health Republic of Korea
GMP Quality System
Standard Operating Procedure
Review of Utilization Plan(Draft)
Registration and Evaluation of Utilization Plan (by 10 Review Board Members)
Contract signing and provision of GMP Services (Post-monitoring of service goals)
Step Process
Registration of Human Embryonic Stem Cell Lines
GMP Manufacturing Service
Ecosystem Construction for
Research, Development, and
Manufacturing of Stem
Cell·Regenerative Medicine
2. National Stem Banking Service
3. Clinical GMP Manufacturing Service
Requirements for hESC line researchers Mission · Repository of hPSCs
· hPSC Banking, Quality Control and Distribution
· Global Standardization Research for Stem Cell
and Regenerative Medicine
hiPCS Cell lines
Therapy Product
Product
· GMP Quality Test of Clinical Cell Therapy Product
· MCB/WCB Banking of Clinical Cell Therapy Product
· GMP Training
· GMP Consulting
(BIOETHICS AND SAFETY ACT, Article 33)
A person who establishes or imports hESC
lines shall register such hESC lines before using
them.
When a person who has established an hESC
line intends to provide it to a third person,
he/she shall undergo examination by the
competent institutional committee and submit
the provision record of the year to KDCA.
Floors Facility
5 AHUs
2 Cell Bank, R&D Lab., Office
1 Meeting room, BMS room
B1 Mechanical, Electrical
GMP Manufacturing Facilities
· GMP area : 1,620m²(3rd floor)
Collection of Pluripotent Stem Cells ( '21.05)
Type Number Note
hESC 19
hiPSC 50
* KNIH-developed line 26 * HLA-homozygote line 23 * Disease specific line 5 (Eye disease 2, CMT 3) * GFP-tagged line 4 * Parthenogenic line 3
National Center for Stem Cell and Regenerative Medicine
Stem cell bank GMP Facility Cooperation network
Proprietary technology
technology
and related materials
Develop proprietary
Clinical Researchers (Medical institution)
Provide research- use stem
(, )
Stem cell bank GMP Facility Cooperation network
Proprietary technology
technology
and related materials
Develop proprietary
Clinical Researchers (Medical institution)
Provide research- use stem
Stem cell bank GMP Facility Cooperation network
Proprietary technology
technology
and related materials
Develop proprietary
Clinical Researchers (Medical institution)
Provide research- use stem
Stem cell bank GMP Facility Cooperation network
Proprietary technology
technology
and related materials
Develop proprietary
Clinical Researchers (Medical institution)
Provide research- use stem
Localization of related materials
· ·
Outside review board meeting
GMP Area Layout
· One-way pathway to maintain aseptic conditions
in aseptic process room
Suite 2
A person who intends to use hESC lines
shall submit the relevant research plan to
be examined by the competent institutional
committee and approval thereof from the head
of the relevant institution and then report
relevant facts to KDCA.
http://nih.go.kr/ncsr
e-mail [email protected]
Phone +82-43-249-2531
Type Cell Name Note
DKH090i-A Eye disease (Leber congenital amaurosis)
Division of Intractable Disease Research
e-mail [email protected]
Phone +82-43-249-2518
Website http://nih.go.kr/ncsr
Regenerative Medicine
Procedure for GMP Manufacturing Facility Use
GMP Equipment and Quality System
Location
the development of advanced therapy medicinal
products in regenerative healthcare fields
· Verified safety and efficacy of products at GLP facilities
· Completed the GMP manufacturing process and
analytical methods
nine (9) months
finishing manufacturing of products
· Ripple Effect of Regenerative Medicine
Fees of Service Minimum price to reduce the cost burden of users
http://nih.go.kr/ncsr
Cheongju-si, Chungcheongbuk-do, 28160, Korea
TEL . +82-43-249-2533
FAX . +82-43-249-2548
And Regenerative Medicine
Division of Intractable Disease Research
e-mail [email protected]
Phone +82-43-249-2533
researcher's investigation cell therapy drug for clinical
phase 1 or phase 1/2a
National Institute of Health Republic of Korea
National Institute of Health Republic of Korea
GMP Quality System
Standard Operating Procedure
Review of Utilization Plan(Draft)
Registration and Evaluation of Utilization Plan (by 10 Review Board Members)
Contract signing and provision of GMP Services (Post-monitoring of service goals)
Step Process
Registration of Human Embryonic Stem Cell Lines
GMP Manufacturing Service
Ecosystem Construction for
Research, Development, and
Manufacturing of Stem
Cell·Regenerative Medicine
2. National Stem Banking Service
3. Clinical GMP Manufacturing Service
Requirements for hESC line researchers Mission · Repository of hPSCs
· hPSC Banking, Quality Control and Distribution
· Global Standardization Research for Stem Cell
and Regenerative Medicine
hiPCS Cell lines
Therapy Product
Product
· GMP Quality Test of Clinical Cell Therapy Product
· MCB/WCB Banking of Clinical Cell Therapy Product
· GMP Training
· GMP Consulting
(BIOETHICS AND SAFETY ACT, Article 33)
A person who establishes or imports hESC
lines shall register such hESC lines before using
them.
When a person who has established an hESC
line intends to provide it to a third person,
he/she shall undergo examination by the
competent institutional committee and submit
the provision record of the year to KDCA.
Floors Facility
5 AHUs
2 Cell Bank, R&D Lab., Office
1 Meeting room, BMS room
B1 Mechanical, Electrical
GMP Manufacturing Facilities
· GMP area : 1,620m²(3rd floor)
Collection of Pluripotent Stem Cells ( '21.05)
Type Number Note
hESC 19
hiPSC 50
* KNIH-developed line 26 * HLA-homozygote line 23 * Disease specific line 5 (Eye disease 2, CMT 3) * GFP-tagged line 4 * Parthenogenic line 3
National Center for Stem Cell and Regenerative Medicine
Stem cell bank GMP Facility Cooperation network
Proprietary technology
technology
and related materials
Develop proprietary
Clinical Researchers (Medical institution)
Provide research- use stem
(, )
Stem cell bank GMP Facility Cooperation network
Proprietary technology
technology
and related materials
Develop proprietary
Clinical Researchers (Medical institution)
Provide research- use stem
Stem cell bank GMP Facility Cooperation network
Proprietary technology
technology
and related materials
Develop proprietary
Clinical Researchers (Medical institution)
Provide research- use stem
Stem cell bank GMP Facility Cooperation network
Proprietary technology
technology
and related materials
Develop proprietary
Clinical Researchers (Medical institution)
Provide research- use stem
Localization of related materials
· ·
Outside review board meeting
GMP Area Layout
· One-way pathway to maintain aseptic conditions
in aseptic process room
Suite 2
A person who intends to use hESC lines
shall submit the relevant research plan to
be examined by the competent institutional
committee and approval thereof from the head
of the relevant institution and then report
relevant facts to KDCA.
http://nih.go.kr/ncsr
e-mail [email protected]
Phone +82-43-249-2531
Type Cell Name Note
DKH090i-A Eye disease (Leber congenital amaurosis)
Division of Intractable Disease Research
e-mail [email protected]
Phone +82-43-249-2518
Website http://nih.go.kr/ncsr
