Lyophilization - Home | Pharmaceutical Outsourcing

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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 DEVELOPMENT & COMMERCIAL SERVICES Ferentino, Italy late phase clinical and commercial manufacturing Monza, Italy late phase clinical and commercial manufacturing – cephalosporins only Swindon, UK For more information, email us at [email protected]
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Transcript of Lyophilization - Home | Pharmaceutical Outsourcing

product development services and
range of molecule types, large or small.
Development Services
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
Specialized Lyophilization Development Capabilities Include:
• preformulation and formulation development
• registration/validation batches
Lyophilization Sites
D EV
ELO PM
EN T &
C O
M M
ERC IA
late phase clinical and commercial manufacturing – cephalosporins onlySwindon, UK
For more information, email us at [email protected]
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 Capacity Our 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
US Headquarters
Patheon Inc. 4721 Emperor Blvd, Suite 200 Durham, NC 27703-8580 USA P: +1 919 226 3200 F: +1 919 474 2269 www.patheon.com
European Headquarters
Patheon UK Ltd. Kingfisher Drive Covingham, Swindon Wiltshire SN3 5BZ UK P: +44 1793 524411 F: +44 1793 487053 www.patheon.com