■ Outline
Yokohama
Name
Yokohama Biopharmaceutical Research and Development Center
Location
Yokohama Bio Industry Center 2F, 1-6 Suehiro-cho, Tsurumi-ku,
Yokohama, Kanagawa 230-0045, Japan
Floor Space
GMP-controlled Facility
745㎡
Manufacturing Technology Research Laboratory
130㎡
Office
Research and
51㎡
Total
Construction fund
Biopharmaceutical
926㎡
Development Center
Subsidy from Ministry of Economy, Trade and Industry;
Loan from City of Yokohama, etc.
Organizer
Kihara Memorial Yokohama Foundation
for the Advancement of Life Sciences
Support
Economic Affairs Bureau, City of Yokohama
Designer/builder
Chiyoda Corporation
Inauguration
April, 2011
YBIRD
■ Kihara Memorial Yokohama Foundation
for the Advancement of Life Sciences
Office
1-6 Suehiro-cho, Tsurumi-ku, Yokohama, Kanagawa 230-0045, Japan
Establishment
March 12, 1985
(authorized as Public Interest Incorporated Foundation on
April 1, 2013)
Stated capital
About ￥800 million
(incl. ￥500 million donated by City of Yokohama)
Representative
Makoto Umeda, Chairperson of the Board of Trustees
Principal line of business Life science advancement and application to activate industry in
Kanagawa prefecture, by organizing co-researches of industry and
academia in life sciences to act organically coordinating, and by
encouraging academic exchanges and science promotion to appeal
broadly in society of life science researches importance
欧文ロゴ
JR Keihin-Tohoku Line
■ For contact /inquiry
JR Tsurumi Sta.
To Yokohama
To Kawasaki
Keihinkyuko Line
Keihin No.1 highway
Kokudo Sta.
Metro.
Expressway
Yoko-hane Line
Namamugi IC
Keikyu-Tsurumi Sta.
Aboard buses of
Kawasaki-Turumi
Rinko Bus
Tsurumi-ono Sta.
Shioiri IC
Tsurumi River
Riken/City
Univ.
Fure-yu
To Haneda
Airport
JR Tsurumi Line
Riken/Shidai-Daigakuin-mae
Bus stop
Yokohama Biopharmaceutical R&D Center
（Yokohama Bio Industry Center 2F）
Yokohama Bio Industry Center, 1-6 Suehiro-cho, Tsurumi-ku,
Yokohama, Kanagawa 230-0045, Japan
Phone: +81-(0)45-502-4810 Fax: +81-(0)45-502-9810
E-Mail: [email protected] URL: http://www.kihara.or.jp
● At No.7 stop of Tsurumi Sta. Bus Terminal(*), take Tsuru-08
route bus (Kawasaki-Tsurumi Rinko Bus) bound for Fure-yu . In
about 12 min. get off at Riken/Shidai-daigakuin-mae .
* In front of east exit of Tsurumi Sta. on JR Keihin Tohoku Line
or Keikyu- Tsurumi Sta. on Keihinkyuko Line
● 15 min. on foot from Tsurumi-ono Sta. on JR Tsurumi Line
P06-0020
この印刷物は、E3PA のゴールドプラス基準に適合した
地球環境にやさしい印刷方法で作成されています
E3PA ：環境保護印刷推進協議会
http://www.e3p a.com
2013.10
Kihara Memorial Yokohama Foundation
for the Advancement of Life Sciences
YBIRD is a core GMP facility
for supporting the development of protein drugs and
manufacturing technologies.
Functions as a Core GMP Facility
１ Collaborative R&D for protein drug seeds
on the preparation of the samples and for
manufacturing process technologies
２ Process development, scale-ups, and GMP
preparation of investigational new drug
(protein APIs)
３ Personnel training for protein manufacturing
skills and GMP regulations
Process Lab.
Seeds
(drug candidates,
manufacturing
technologies)
Experimental
evaluation,
Clinical trial
・Process Development
・Development of
manufacturing
technologies
Preparation of
Recombinant proteins
GMP-controlled Facility
Preparation of
API of investigational
drugs in compliance
with GMP regulations
API of investigational drugs, Samples for GLP tox., etc.
D ev elo pm en t Cen ter
YBIRD
Area
Main Equipments
Culture
Animal cell
・CO2 incubators
・Bioreactors 0.1 25L, 50 100L, 250 500L
(electrically driven bioreactors, single-use bag type)
・Membrane separation system
Culture
Microbial
・Shaking incubators
・Fermentor : 300L (actual liquid volume : approx.200L)
・Microbial cell disruption equipment : high pressure homogenizer
・Microbial cell separator : continuous centrifuge
Purification
Animal cell
Microbial
・Chromatography chamber (cold room) ・Purification equipment (AKTA Pilot), etc.
・Purification columns ・Virus filter
Filling
Common area
・Clean bench
・Water and steam : water-for-injection equipment, pure steam equipment
・Ventilation : HEPA filter, controlled temperature and humidity,
intra-room differential air pressure and air cleanness quality control.
・Analytical instruments for quality control
Concept
Development stages ‥‥‥‥‥From nonclinical to early phase Ⅱ clinical
Hosts for protein expression ‥‥Microbial (E.coli and yeast) and
R esea r ch a n d
Process
Others
studies
B i o ph a rm a ceu tica l
Main Equipments in GMP-Controlled Areas
YBIRD
Academia Biotechs
Yo ko h a m a
Air-conditioner and
water equipment for preparation
Floor Plan in GMP-Controlled Areas
Controlled area
Gas cylinder WH
Table lifter
animal cells (floating cells such as CHO cells)
Complying GMP standards ‥‥‥c GMP and J-GMP
Animal cell area
Biosafety level ‥‥‥‥‥‥‥‥BSL-1 and GILSP1
Specialty
Contents
1. Simultaneous
operationability for both
microbial and animal cell
lines
・Microbial area and animal cell area are arranged to
keep independence and thoroughly separated by a
hallway.
・None of the devices for culture or purification
processes are shared between the two areas.
2. Reduced burden in
cleaning validation
・Single-use systems are employed.
(animal cell culture bioreactors, receptacles for
culture medium, fractions / drainage in purification
steps, etc.)
・Automated operating system to eliminate human
errors
3. Highly aseptic equipments
by eliminating human
・Highly aseptic assurance in culture systems
errors
・Reduced bioburden in process devices
・Water-for-injection is used for manufacturing.
Tertiary
dress RM
DS
Purification RM
PB
Machinery RM-1
PB
P/R
P/R-4
PB
WH
Purification RM
Common
Men s
anteroom-1
initial
Women s
dress
initial dress
RM
RM
Machinery
RM-2
Pre-culture
RM
P/R-1
A/L-2
Weighing/
preparation
RM
Waste WH
A/L
Secondary
dress RM
WH-2
PB
P/R-2
WH-3
Note
A/L-1
Class 100,000 Controlled area
Mat. trans. hallway
A/L
Filling RM
Culture RM
Wash RM
P/R-4
DS
Dress RM
Clean
equipments
Dry area
storage
Quality control RM
A/L
CNC hallway
P/R-3
Clean hallway
Boiler chamber
Clean
equipments
storage
Wash RM
Clean hallway
PB
Culture RM
Dry
area
Tertiary
dress RM
DS
CNC(Controlled Not Classified)
P/R-2
P/S
P/R-3
Microbial area
Hallway
Pre-culture
RM
WH-1
Weighing
/preparation
RM
Dress RM
CNC hallway
A/L-1
Secondary
dress Common
A/L-2 RM
anteroom-2
P/R-1
Gen. air-conditioned area
Ventilation only area
Acronyms
A/L：Airlock
P/R：Passroom
P B：Passbox
D S：Ductspace
office
RM：Room
WH : Warehouse