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