SAFC – Carlsbad Facility

cGMP Viral Product Development and Manufacturing

Carlsbad Manufacturing – California

SAFC'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 12 years experience, SAFC works closely with customers to develop and manufacture exciting new treatments for cancer, cardiovascular and central nervous system diseases.

>> Carlsbad Facility (315 Kb PDF)

	Biosafety Level 2 cGMP Facility
	cGMP Viral Bulk Drug Substance Manufacturing
	cGMP Cell and Viral Banking
	Process Development
	Sterile Fill / Finish
	Secure cGMP Biostorage

>> Capabilities Overview
>> Current Product List
>> cGMP Cell and Viral Banking
>> Quality Control and Process Development
>> Sterile Fill/Finish
>> Secure cGMP Biostorage

Capabilities Overview
	Separate facility for scale-up, process validation, Phase 3 trials and commercial launch
	Unidirectional personnel and materials flow layout
	Eight client-dedicated Class 10,000 (ISO 7) Clean Room suites
	Single-pass air exhausted directly from clean rooms
	Aseptic manipulations performed in Class 100 (ISO 5) Biosafety cabinets
	Two dedicated Class 1,000 (ISO 6) Fill Suites
	Highly-qualified process development teams focused on early-stage process optimization and scale up
	Successful history of technology transfers for complex processes
	Extensive QC and QA programs to support early-stage through commercial manufacturing

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 specific experience in:
	Multiple cell culture systems for adherent or suspension cells
	Stainless steel bioreactors up to 100 L
	Multiple Wave™ bioreactors
	Cell factories
	Shake flasks
	Cell cubes
	Column chromatography
	Tangential flow filtration
	Membrane absorption
	Gradient centrifugation
	Formulation

cGMP Cell and Viral Banking
	Screening for clonal derivatives early in the development process
	Viral seed stock characterization to determine the optimal processing parameters for manufacturing
	Process development (including clonal selection)
	Access to PER.C6™ cell line
	Master and working cell banks in any SAFC cell culture system
	Master and working viral banks manufactured in dedicated viral suites

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.
	Process optimization
	Scaled up manufacturing for pharmacologic/toxicity studies
	Stability and formulation studies
	Transfer of client-based processes for reproducibility assessment (prior to cGMP production)
	Transfer, qualification and validation of product specific assays (HPLC, PCR, immuno assays and cell based assays)
	PCR assay development
	Process validation

Sterile Fill/Finish
	Filtering, filling and finishing services
	Highly trained operators
	CGMP EU and FDA compliant
	Dedicated class 100 (ISO 4) filling suites
	Semi-automated and automated systems
	Capacity from 2,000 to 10,000 vials a day
	Glass vials, cryovials and glass syringes available
	Use of disposable tubing, containers and needles for all surfaces in contact with products

Secure cGMP Biostorage
	Controlled temperature freezers of -80 °C and -20 °C
	on-site liquid nitrogen dewars for final product storage
	Continuous monitoring via a networked system of data loggers
	Alarm notification system
	Restricted key-card access
	Complete freezer inventories
	Full documentation
	Diesel-powered emergency generator
	Additional local alarms tied to building management system