Meridian Biologics Regulatory and Quality Assurance

Quality is our primary focus, with all management, administrative, and production personnel involved in the process. This is re-enforced through procedures, training, and supervision. Viral Antigen's quality policies and procedures are intended to assure that our products meet or exceed customer expectations. Quality improvement is continuous and subjects all policies and procedures to periodic review.

Standard tests include:

•	Purity Testing by Western Blot and Silver Stain
•	HPLC profiling
•	ELISA assay, direct or capture
•	Bioburden
•	Endotoxin testing
•	Qualified cGMP laboratories used for: _ Identity testing      (N-Terminal Analysis, AAA, etc.) _ Adventitious agents

Our technical experience includes using plaque assay and end point dilution for determination of viral titer. New assays can be developed to fulfill any requirement.

Meridian Biologics has a strong commitment to quality and regulatory compliance. We are also flexible and know that clients may have additional requirements to be integrated into Viral Antigens' existing documentation.