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 improvements that can increase yield
qualified disinfectant cleaning procedures.
In addition to our state-of-the-art PLR facility
Quality Management
we offer:
• Independent Quality Assurance (QA) unit
• Phase-specific analytical development
• Highly experienced staff
• Characterization, certification and control
• Clinical product successfully manufactured
of all incoming raw materials
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
information and production timelines.
• Characterization studies (determine MOI)
• Media development (through respected
sister company, SAFC Biosciences™)

*PER.C6 cells are manufactured COMMERCIALIZATION

under license to Crucell, N.V.
Commercial clients must have PRE-CLINICAL
a separate research and/or
PHASE 2 PHASE 3
commercial license from Crucell, PHASE 1
N.V. PER.C6 cells are available
for academic and governmental
clients through payment of project- SAFC Pharma can support viral vaccines and therapeutic requirements
specific access fees. 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