lyophilization - home | pharmaceutical outsourcing
Post on 09-Feb-2022
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Patheon offers fully integrated lyophilized
product development services and
commercial manufacturing for a wide
range of molecule types, large or small.
Development Services
Patheon’s highly skilled development scientists
have the experience and expertise to develop your
molecule in a lyophilized form. The lyophilization
development team has participated in over 100
client development projects, with over 30 for
biopharmaceuticals, including proteins, peptides
and monoclonal antibodies (MAbs), since 2004.
Specialized Lyophilization Development Capabilities Include:
• preformulation and formulation development
• full analytical development
• lyophilization cycle development
• cycle-time optimization
• Clinical Trial Materials (CTM) manufacturing
• registration/validation batches
• scale-up
• technical transfers
Lyophilization
full phase development services and commercial manufacturing
Lyophilization Sites
DEV
ELOPM
ENT &
CO
MM
ERCIA
L SERVIC
ES
Ferentino, Italy
late phase clinical and commercial manufacturingMonza, Italy
late phase clinical and commercial manufacturing – cephalosporins onlySwindon, UK
For more information, email us at doingbusiness@patheon.com
Development Scale Lyophilizers• 0.2 m2 Martin Christ Epsilon 2-6D (with “Sample Thief” system)
• 0.4 m2 Edwards Lyoflex 04
• 7 m2 BOC Edwards (cGMP)
Modifications have been made to both the 0.2 m2 and 0.4 m2 development scale lyophilization units so they
match the performance of the larger scale production units, thereby making scale-up easier and more efficient.
Process Optimization
Our “Sample Thief” equipped lyophilization unit allows residual moisture analyses during lyophilization
development cycles enabling scientists to optimize the length of the production cycle by directly monitoring the
correct length of the drying process for each project.
Commercial CapacityOur manufacturing areas were constructed using specialized building
materials and incorporate robust environmental control systems. “Clean in place” (CIP) and “steam in place” (SIP) functions ensure
consistent sterilization of the chambers and the processing equipment.
Patheon offers state-of-the-art lyophilization capacity at its Ferentino and Monza, Italy facilities. Our five first-in-class manufacturing suites
house nine modern lyophilization units ranging in size from 10 m2 to 42 m2, with a combined capacity of 3,068 ft2 (285 m2).
Patheon’s Swindon Operations opened an advanced manufacturing facility in 2007, dedicated to the manufacture of lyophilized
cephalosporins. This facility houses four 55 m2 lyophilization chambers and also incorporates temperature control during
the manufacturing process for compounding and filling.
Exceptional Quality
Patheon’s sterile manufacturing facilities meet the highest quality standards of Europe and abroad. In addition to holding European regulatory
approval, these three facilities have been successfully inspected by the U.S. FDA on numerous occasions, proof of our exceptional quality record.
Lyophilization DEVELOPMENT & COMMERCIAL SERVICES
Published 4/12 PATH0147R3
US Headquarters
Patheon Inc.4721 Emperor Blvd, Suite 200Durham, NC 27703-8580USAP: +1 919 226 3200F: +1 919 474 2269www.patheon.com
European Headquarters
Patheon UK Ltd.Kingfisher DriveCovingham, SwindonWiltshire SN3 5BZUKP: +44 1793 524411F: +44 1793 487053www.patheon.com
For more information on our Lyophilization services, contact your Patheon representative or email us at doingbusiness@patheon.com
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