Safc Pharma - Viral Vaccines & Therapeutics

SAFC Pipeline Partners ®

Complex technologies

Development and cGMP Manufacturing

Viral Vaccines & Therapeutics With over a decade of experience in manufacturing viral vectors and vaccines, SAFC Pharma™ has industry-leading expertise in this complex emerging technology. From process development to cGMP manufacturing of clinical drug products and final fill/finish, the company provides development and manufacturing services that support the industry’s demand for cutting-edge complex viral vectors and vaccine drug development. SAFC Pharma combines over 10 years experience with highly trained personnel and state-of-the-art facilities including recently expanded analytical and manufacturing capabilities to support customers from pre-clinical to commercial-scale quantities. Vaccines Development & Manufacturing Vaccines have undergone a renaissance in the past decade as new manufacturing techniques and new indications have spurred investment into next-generation candidates. SAFC Pharma has experience working with small and large biotechs for such indications as influenza, pandemic flu, AIDS, malaria and other therapeutic vaccines. Therapeutics Development & Manufacturing SAFC Pharma has supported gene therapy clients for over 10 years. While SAFC Pharma has manufactured GMP products for all major viral vector systems and many clinical trials, most indications now revolve around oncology, cardiac and CNS diseases. Examples of our Service Offering: • cGMP Viral Bulk Drug Substance manufacturing • cGMP Cell and Viral Banking • Sterile Fill and Finish • Secure Biostorage • Access to fully characterized 293-clonal cell line (AC2) • Access to PER.C6™ cell line*

www.safcpharma.com

SAFC Pipeline Partners ®

Complex technologies

Development and cGMP Manufacturing Viral Vaccines and Therapeutics QC and Analytical Services

Traditional or Disposable Bioreactor Selection

SAFC Pharma provides customers with

• Wave

complete support, including the development

• Single Use Bioreactor (SUB)

of specifications, risk assessment,

• Upstream and downstream process

implementation of process controls and qualified disinfectant cleaning procedures. In addition to our state-of-the-art PLR facility we offer: • Phase-specific analytical development • Characterization, certification and control of all incoming raw materials

improvements that can increase yield Quality Management • Independent Quality Assurance (QA) unit • Highly experienced staff • Clinical product successfully manufactured for trials in US, EU and Asia

• QC testing of in-process materials

• Rigorous compliance program

• Release testing as requested • Stability studies

Project Management

With extensive experience in process

SAFC’s project managers lead multi-functional

development, our chemists prepare bench-

teams in support of custom cGMP projects.

scale processes for development to Phase I

Our Project Managers serve as a single point

production using capabilities in:

of contact for customers, and help facilitate the timely communication of important technical

• Vector construction • Characterization studies (determine MOI)

information and production timelines.

• Media development (through respected sister company, SAFC Biosciences™)

*PER.C6 cells are manufactured under license to Crucell, N.V. Commercial clients must have a separate research and/or commercial license from Crucell, N.V. PER.C6 cells are available for academic and governmental clients through payment of projectspecific access fees.

COMMERCIALIZATION

PRE-CLINICAL PHASE 1

PHASE 2

PHASE 3

SAFC Pharma can support viral vaccines and therapeutic requirements from pre-clinical to commercialization phases.

Sigma-Aldrich® and SAFC® are registered trademarks and SAFC Pharma™and SAFC Biosciences™ are trademarks of Sigma-Aldrich Biotechnology L.P. and Sigma-Aldrich Co. PER.C6™ is a trademark of Crucell, N.V. © 2008 SAFC All rights reserved.

04516-506486 KQA 0088

www.safcpharma.com