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Viral vaccines and Gene Therapy |
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SAFC Pharma - Virus Manufacturing |
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SAFC Pharma Virus manufacturing capabilities are provided from our Carlsbad, California facility, which previously operated under the name of Molecular Medicine BioServices (MMB). MMB was acquired by SAFC in May, 2007 in order to provide clinical and commercial manufacturing services for this exciting and growing segment of the biopharma industry.
SAFC Carlsbad specializes in clinical manufacturing of intermediates and final products used in viral vaccines and gene therapies. Through the use of a state-of-the-art facility, SAFC Carlsbad utilizes a variety of bioreactors and purification processes to produce high titer, high purity product. Bulk drug can be filled in the company's ISO 6 (Class 1000) clean room and stored in its controlled GMP storage area.
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Technical Expertise
SAFC Carlsbad has been involved in the development and cGMP production of viral products since 1997. In early 2006, the company added significant Process Development and Quality Control capabilities when it moved into new labs.
More than one-fourth of the biologics in development are within SAFC Carlsbad capabilities, including treatments for Cancer, Cardiovascular Disease, and Alzheimer's Disease. The Carlsbad facility has produced clinical-grade drug products for each of these therapeutic indicators. The company's manufacturing methods and technical know-how are well suited for next generation vaccines for Influenza, Pandemic Flu, AIDS, West Nile Virus, and malaria. Nearly one-fifth of the CDC Category A-C Biodefense agents are viral in nature and SAFC Pharma is capable of producing counter agents to these deadly viruses.
Manufacturing Methods and Technology
Clients have asked SAFC Pharma to manufacture product using a variety of different systems. SAFC Pharma utilizes mammalian cell culture to grow cells in systems as diverse as cell factories, Wave™ bioreactors, and Stir Tank systems. SAFC Pharma can perform many functions at scale in their separate, Process Development labs.
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Technical Achievements
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>300 clinical lots produced |
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Adenovirus, Retrovirus, AAV, Lenti and others |
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Fully tested master and working banks |
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Adherent and suspension cells |
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Facility Overview
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BioSafety Level 2 |
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Single pass air directly exhausted out of clean rooms |
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6 client dedicated ISO7/class 10,000 clean room suites |
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1 ISO6/class 1,000 Fill Suite |
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All aseptic manipulations performed in ISO5/class 100 BSCs |
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Unidirectional flow of personnel and materials |
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Documentation and Filings
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Facility Type V DMF |
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Adenovirus Type II DMF |
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Over 800 Item Specs, SOPs, and Batch Records written in 2005 |
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Certificate of Compliance signed upon SAFC Review |
Client is responsible for final release of clinical product |
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Quality Assurance
Quality Assurance is fundamental to the satisfactory delivery of products and services to our customers. Each employee is responsible to perform every function to cGMP and SAFC requirements.
The Quality Assurance organization is responsible for establishing SAFC's quality policies and ensuring compliance with appropriate FDA regulations.
SAFC Pharma follows written procedures as defined within the Quality Systems group, including Change Control, Training, Validation, internal and external audits, and investigations/CAPA.
SAFC will certify that any product manufactured at the company meets compliance guidelines and certain specifications, including bioburden/sterility, mycoplasma, and endotoxin. The company has hosted over 80 client audits since 2001, including 40 since the company moved into its new manufacturing facility in Carlsbad, CA in 2005. Clients will be able to access SAFC’s Drug Master Files as appropriate and SAFC's QA staff will work closely with the Client to ensure that Batch records, sampling plans, and shipping are coordinated and appropriately controlled. |
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| Cell experience (*=GMP) |
| PER.C6* |
AC2* |
MG6* |
| HT1080 |
MRC5* |
ORF-6* |
| Other* |
A549 |
VERO |
Other viral vector systems
(*=client provided process) |
| PER.C6* |
AC2* |
MG6* |
| HT1080 |
MRC5* |
ORF-6* |
| Other* |
A549 |
VERO |
| Media and Product Fills |
Small Hand Fills |
Semi-Automated Closed System Fills (2000 vials) |
Automated Fills (available Q2 2007) |
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For more information, please visit the Molecular Medicine BioServices website at www.molecularmed.com. |
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