Custom Formulation and Fill / Finish

Complex Technologies

SAFC Pharma® provides fill/finish services for biologic drug products as well as small-molecule APIs up to 10,000 vials per lot.

Our highly trained teams have a service record of more than 500,000 vials and syringes filled for over 300 lots without a single sterility failure.

Semi-Automated and Fully-Automated Fills
	Capacity: up to 10,000 vials/lot
	0.15-23 mL fill volumes
	0.3-30 mL vial size
	Typical turnaround of 10 weeks (plus testing) - expansion possibilities based on customer demand
	Glass vials, cryovials, syringes and bags available
	Final product, diluents, placebo
	Labeling options for fully-blinded studies
	Automated labeling equipment

Key Features of the Filling Operations
	Strict accordance to cGMP standards, with robust quality systems that ensure every fill is performed according to specification
	Highly-experienced personnel
	Optimized documentation systems for efficient project turn-around
	On-site storage
	IATA certified shipping

Facility suited for FDA and EU-regulated clinical trials and features
	BSL2 (BioSafety Level 2) enhanced containment
	Class 1,000 (ISO 6) suites and Class 100 (ISO 5) Biosafety cabinets
	100% single-pass HEPA filtered air

Quality Management
	Dedicated quality assurance (QA) teams
	Highly experienced specialists
	Clinical product successfully filled for trials in US, EU and Asia
	On-site storage
	Rigorous compliance program

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