Characterization of materials and processes used in the development and manufacture of biopharmaceuticals and in the evaluation of the safety of products are critical considerations to the biotechnology and pharmaceutical industries. Following FDA's "Points-To-Consider" guidelines, biologics manufacturers can implement testing programs for production and purification of biological products.

Advanced Biotechnologies Inc has expertise in four niche areas of virology that are critical to Bioprocess Validation: large-scale eukaryotic cell culture, virus production and purification, and electron microscopy services. These integrated technical capabilities provide a valuable resource to assist manufacturers with the following concerns of large-scale bioproduct manufacturing:

• High-titered virus preparations in sufficient volumes for spiking studies.
• Virus detection and quantitation by centrifugation.
• Virus detection and quantitation by electron microscopy.

ABI enjoys close-working relationships with the leading full-service bioprocess validation companies and can assist you with your specific needs. Please call Advanced Biotechnologies Inc to discuss your requirements.