レファレンス

GRAM
Grand River Aseptic Manufacturing
140 Front Avenue SW
Grand Rapids, MI 49504 / USA
www.grandriverasepticmfg.com

Video auf YouTube - Innovative Modular Technology at GRAM
Georgia
Georgia Bioscience Training Centre
320 Baxter Parkway
SOCIAL CIRCLE, GA 30025/USA
www.GeorgiaQuickStart.org

Video on YouTube - The Georgia Bioscience Training Center
Boehringer
Boehringer Ingelheim Fremont, Inc.
6701 Kaiser Drive
FREMONT, CA 94555/USA
www.boehringer-ingelheim.com

Link press article: pharmaceutical online
Selkirk
Selkirk Pharma
827 W First Avenue
Suite 401
Spokane, WA 99201 / USA
www.selkirkpharma.com

Link Interview: Contract Pharma
Evonik
Evonik Degussa Corporation
Birmingham Laboratories
750 Lakeshore Parkway
BIRMINGHAM, AL 35211 / USA
www.evonik.com

Evonik press release
Evonik White Paper – VarioSys® Aseptic Filling Line PDF
Evonik Case Study PDF
Argonaut
Argonaut Manufacturing Services
2841 Loker Ave E
Carlsbad, DA 92010
www.argonautms.com

Contract Manufacturer for Drug Product Vial Fill/Finish

 

VARIOSYS®レファレンス(抜粋)

 
Deliver to... Bausch+Ströbel
Equipment
SKAN
Isolator Equipment
GEA
Equipment
 Remarks
 Boehringer Ingelheim, CA / US  5 modules 3 PSI-L Isolators + SARA  --- FDA approved!
 GSK, Idol Ilac / TR  2 modules 2 PSI-L Isolators  ---  ---
 GSK, Idol Ilac / TR  2 modules 2 PSI-L Isolators  ---  ---
 Georgia BioScience, GA / US 1 module 1 PSI-L Isolator + SARA  ---  ---
 *** East Coast / US 4 modules 2 PSI-L Isolators  ---  ---
 Evonik, AL / US 3 modules + washer and tunnel 3 PSI-L Isolators + SARA  4,5 m² Lyo  toxic
 Teligent, NJ / US 2 modules + washer and tunnel 1 PSI-L Isolator --- ---
 Boehringer, Shanghai / CN 2 modules + washer and tunnel 2 PSI-L Isolators + SARA --- FDA approved!
 MSD Werthenstein BioPharma GmbH
Schachen / CH
2 modules 2 PSI-L Isolators + SARA --- ---
 **** Bagsvaerd / DK 2 modules 2 PSI-L Isolators --- ---
 Baxter Wien / AT 1 module 1 PSI-L Isolator + SARA --- ---
 **** West Coast / US 7 modules 4 PSI-L Isolators + SARA --- ---
 Thermo Fisher Scientific, MA / US 2 modules 2 PSI-L Isolators + SARA --- ---
 Bio Marin, CA / US 1 module 1 PSI-L Isolator + SARA --- ---
 McGuff, CA / US 2 modules + washer and tunnel 2 PSI-L Isolators --- ---
 Regeneron, NY / US 1 module 1 PSI-L Isolator + SARA --- ---
 Pfizer Meridian, MO / US 2 modules 5 PSI-L Isolators --- ---
 Bio Marin, CA / US 2 modules 2 PSI-L Isolators --- ---
 Argonaut Manufacturing Services, CA / US 2 modules + RABS capper 2 PSI-L Isolators + SARA --- FDA approved!
 Henogen SRL, Thermo Fisher Scientific, Gosselies / BE 2 modules + RABS capper 2 PSI-L Isolators + SARA --- ---
*** / DE 5 modules + washer and tunnel 4 PSI-L Isolators 4,5 m² Lyo ---
Thermo Fisher Scientific, MA / US 2 modules 2 PSI-L Isolators + SARA --- ---
Regeneron, NY / US 5 modules 4 PSI-L Isolators + SARA 4,5 m² Lyo ---
Takara Bio, Shiga / JP 1 module + washer and tunnel 1 PSI-L Isolator + SARA --- ---
Bluebird Bio, NC / US 2 modules 2 PSI-L Isolators + SARA --- ---
Thermo Fisher Scientific, MA / US 1 module 1 PSI-L Isolator + SARA --- ---
Exelead, IN / US 2 modules + RABS capper 3 PSI-L Isolators + SARA 4,5 m² Lyo ---
Patheon, Ferentino / IT 3 modules 4 PSI-L Isolators + SARA 4,5 m² Lyo ---
Selkirk Pharma, US 1 module + washer and tunnel 2 PSI-L Isolators + SARA --- ---
Novartis Gene Therapies, NC / US 2 modules 2 PSI-L Isolators + SARA --- ---
Gilead, CA / US 5 modules 4 PSI-L Isolators + SARA 11,3 m² Lyo ---
Bluebird Bio, NC / US 1 module 1 PSI-L Isolator + SARA --- ---
Audentes, CA / US 2 modules 2 PSI-L Isolators --- ---
Millipore Sigma, CA / US 1 module 1 PSI-L Isolator + SARA --- ---
*** West Coast / US 1 module 1 PSI-L Isolator + SARA --- toxic
Wuxi STA, Jiangsu Province / CN 5 modules 4 PSI-L Isolators 4,5 m² Lyo ---
Grand River Aseptic Manufacturing MI / US 4 modules + washer and tunnel + RABS Capper 2 PSI-L Isolators --- ---
Thermofisher Biopharma Services Pte Ltd, Singapore / SG 2 modules 2 PSI-L Isolators + SARA --- ---
Vibalogics, MA / US 2 modules 2 PSI-L Isolators + SARA --- ---
Lonza AG, Stein / CH 5 modules + washer and tunnel 5 PSI-L Isolators 2 x 4,5 m² Lyo toxic with ARM external washer
*** / TW 4 modules + washer and tunnel 2 PSI-L Isolators --- toxic
Ultragenyx Pharmaceutical Bedford, MA / US 2 modules 2 PSI-L Isolators + SARA --- ---
Resilience Allston, MA / US 4 modules 2 PSI-L Isolators + SARA --- ---
Novavax, MD / US 4 modules 2 PSI-L Isolators + SARA --- ---
Gilead, CA / US 1 module (liquid + powder filling) --- --- ---
Janssen, PA / US 3 modules 2 PSI-L Isolators + SARA --- ---
Curia, NM / US 3 modules 2 PSI-L Isolators + SARA --- New syringe filling module
Pfizer, MA / US 2 modules 2 PSI-L Isolators + SARA --- ---
Seagen, WA / US 3 modules 4 PSI-L Isolators + SARA FCM150 toxic OEB5 with ARM external washer
Pfizer, Puurs / BE 3 modules 3 PSI-L Isolators + SARA --- ---
Pfizer, NC / US 1 module 1 PSI-L Isolator + 2 SARA --- ---
Pfizer, NC / US 1 module 1 PSI-L Isolator + 2 SARA --- ---
Armata Pharmaceuticals, CA / US 2 modules 2 PSI-L Isolators --- ---
Millipore Sigma, CA / US 2 modules 2 PSI-L Isolators --- ---
AbbVie / IE 3 modules 3 PSI-L Isolators --- toxic
University of Delaware DE / US 3 modules 2 PSI-L Isolators --- ---