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SAFC Pharma™ – Carlsbad Facility
cGMP Viral Product Development and Manufacturing
 Carlsbad Manufacturing – California
SAFC Pharma’s Carlsbad, California (USA) operations specialize in the clinical manufacturing of intermediates and final products used in viral vaccines and gene therapies.
Leading the field with over eleven years experience, SAFC Pharma works closely with customers to develop and manufacture exciting new treatments for cancer, cardiovascular and central nervous system diseases.
>> Carlsbad Facility (pdf)
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Biosafety Level 2 cGMP Facility |
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cGMP Viral Bulk Drug Substance Manufacturing |
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cGMP Cell and Viral Banking |
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Process Development |
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Sterile Fill / Finish |
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Secure cGMP Biostorage |
| Capabilities Overview |
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Unidirectional personnel and materials flow layout |
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Six client-dedicated Class 10,000 (ISO 7) Clean Room suites |
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Single-pass air exhausted directly from clean rooms |
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Aseptic manipulations performed in Class 100 (ISO 5) Biosafety cabinets |
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Two dedicated Class 1,000 (ISO 6) Fill Suites |
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Highly-qualified process development teams focused on early-stage process optimization and
scale up |
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Successful history of technology transfers for complex processes |
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Extensive QC and QA programs to support early-stage through commercial manufacturing |
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Current Product List
Over 400 lots of viral substance production, (including Adenovirus, Retrovirus, Lentivirus, AAV, Alphavirus and Reovirus), - bioreactor systems and purification technologies along with a comprehensive compliance program spacific experience in:
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Multiple cell culture systems for adherent or suspension cells |
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Stainless steel bioreactors up to 130 L |
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Multiple Wave™ bioreactors |
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Cell factories |
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Shake flasks |
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Cell cubes |
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Column chromatography |
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Tangential flow filtration |
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Membrane absorption |
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Gradient centrifugation |
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Formulation |
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cGMP Cell and Viral Banking
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Screening for clonal derivatives early in the development process |
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Viral seed stock characterization to determine the optimal processing parameters for manufacturing |
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Process development (including clonal selection) |
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Access to fully-characterized 293-clonal cell line (AC2) and PER.C6™ cell lines |
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Master and working cell banks in any SAFC cell culture system |
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Master and working viral banks manufactured in dedicated viral suites |
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Quality Control and Process Development
Our extensive list of tests and characterization studies help us identify manufacturing issues early-on and determine the likely productivity parameters for cGMP manufacturing.
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Process optimization |
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Scaled up manufacturing for pharmacologic/ toxicity studies |
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Stability and formulation studies |
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Transfer of client-based processes for reproducibility assessment
(prior to cGMP production)
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Transfer, qualification and validation of product specific assays (HPLC, PCR, immuno assays
and cell based assays) |
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PCR assay development |
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Process validation |
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| Sterile Fill/Finish |
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Filtering, filling and finishing services |
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Highly trained operators |
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CGMP EU and FDA compliant |
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Dedicated class 100 (ISO 4) filling suites |
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Semi-automated and automated systems |
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Capacity from 2,000 to 10,000 vials a day |
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Glass vials, cryovials and glass syringes available |
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Use of disposable tubing, containers and needles for all surfaces in contact with products |
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Controlled temperature freezers of -80 °C
and -20 °C |
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on-site liquid nitrogen dewars for final product storage |
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Continuous monitoring via a networked system of data loggers |
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Alarm notification system |
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Restricted key-card access |
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Complete freezer inventories |
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Full documentation |
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Diesel-powered emergency generator |
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Additional local alarms tied to building management system |
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