Viral Vaccines & Therapeutics

Complex Emerging Technologies

Development and cGMP Manufacturing of
Viral Vaccines & Therapeutics

SAFC Pharma provides over 10 years experience in manufacturing viral vectors and vaccines with highly trained personnel and state-of-the-art facilities. Recently announced, the expanded analytical and manufacturing capabilities now support customers from pre-clinical to commercial-scale quantities.

Our Offer
	Process development
	cGMP manufacturing of clinical drug and commercial products
	Final fill/finish
	Regulatory compliance services

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 vaccines.

Therapeutics Development & Manufacturing
	While most indications now revolve around oncology, SAFC Pharma has supported gene therapy clients for over 10 years and products for all major viral vector systems and many clinical trials.

Service Offering Examples
	cGMP Viral Bulk Drug Substance Manufacturing
	cGMP Cell and Viral Banking
	Sterile Fill and Finish
	Secure Biostorage
	Containment facility
	Access to fully characterized 293-clonal cell line (AC2)
	Access to PER.C6™ cell line*

QC and Analytical Services
SAFC Pharma provides customers with complete support, including the development of specifications, risk assessment, implementation of process controls and qualified disinfectant cleaning procedures. In addition to our state-of-the-art PCR facility we offer:
	Phase-specific analytical development
	Characterization, certification and control of all incoming raw materials
	QC testing of in-process materials
	Release testing as requested
	Stability studies

With extensive experience in process development, our chemists prepare bench-scale processes for development to Phase I production using capabilities in:
	Vector construction
	Characterization studies
	Media development (through respected sister company, SAFC Biosciences™)

Traditional or Disposable Bioreactor Selection
	Wave
	Single Use Bioreactor (SUB)
	Upstream and downstream process improvements that can increase yield
	Stir-Tank
	Shake Flasks

Quality Management
	Independent Quality Assurance (QA) unit
	Highly experienced staff
	Clinical product successfully manufactured for trials in US, EU and Asia
	Rigorous compliance program

Project Management
	SAFC's Project Managers lead multi-functional teams in support of custom cGMP projects and serve as single-point-of-contact for customers to facilitate timely communication of important technical information and production timelines.

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* 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 project specific access fees.