WOBURN, Mass.--()--Aphios® Corporation, developer of CFI pathogen inactivation technology, today announced that it now offers virology testing services to facilitate and support scaled down viral clearance and inactivation validation studies.
These services will be provided by a highly experienced and qualified team of investigators and scientists using quality systems in Aphios’ Biohazard Safety Level-2 (BSL-2) and BSL-3 suites. According to Dr. Trevor P. Castor, President and CEO, “Aphios has performed viral inactivation studies with over 20 animal and human viruses from polio and Hepatitis A to HIV and MuLV for well over 18 years, and is experienced in working with human and animal viruses known to be associated with viral contamination of medical products, as well as model viruses.”
Viral clearance and inactivation will be performed in BSL-3 facilities following the latest ICH guidelines. Our virology and microbiology laboratories contain automatic liquid handlers, plate readers, PCR readers, pass-through autoclaves, ultra high-speed centrifuges, and are supported by analytical chemistry laboratories with UV/VIS, HPLC-UV-PDA, ELSD and LC-MS-MS equipment. We have extensive downstream process experience. Personnel include an experienced virologist on staff to provide expert consultation, experienced drug development, biologics and regulatory affairs specialists, and well-trained support staff. We follow well-established procedures to perform testing and have the ability to perform GLP and non-GLP studies to suit customer needs and budgets.
Aphios has developed and will make available its proprietary CFI pathogen inactivation and viral clearance technology for enveloped and non-enveloped viruses in human plasma products and biologics with demonstrable experience in design and manufacture of viral inactivation equipment.
Dr. Bruce Jon Compton, Vice President, Drug Development, says, “With expertise in virology, microbiology, chemical engineering, analytical chemistry, biotechnology and drug development, we will work with you to test and validate the efficacy of your manufacturing procedures to demonstrate viral clearance and/or inactivation in conformance with all applicable regulatory guidelines. We will also work with you to meet the compliance requirements of any other country, as required.”
Aphios® Corporation (www.aphios.com), Woburn, MA is a clinical stage biotechnology company developing green, enabling technology platforms for drug discovery and manufacturing, nanotechnology drug delivery and pathogenic drug safety. Aphios is developing enhanced therapeutic products for health maintenance, disease prevention and the treatment of certain cancers, infectious diseases and central nervous system disorders, such as Alzheimer’s disease.