H Aranha-Creado

  • Citations Per Year
Learn More
Infectivity-based assays are the assays of choice for the detection of pathogenic mammalian viruses. While it is intuitively appropriate to conduct testing and validation studies with the known viral burden or a closely related mammalian species, logistic considerations often dictate otherwise. Consequently, bacteriophages have served as suitable surrogates(More)
Retention of bacteriophages (phi 6, PR772, T1, and PP7) and mammalian viruses (poliovirus and influenza A virus) by a hydrophilic triple layer PVDF microporous membrane, the Ultipor VF grade DV50 membrane, was evaluated. Challenges of membrane discs or pleated filter cartridges were performed at concentrations of 10(6)-10(8) PFU/mL in one or more of the(More)
Continuous cell lines (used in the manufacture of monoclonal antibodies and other therapeutic proteins) may harbour retroviral particles; nevertheless, they are deemed acceptable if the production system is validated for clearance of these contaminants. As part of a campaign to evaluate and validate appropriate virus removal methodologies for monoclonal(More)
Advances in membrane technology have allowed the expansion of the size-exclusion removal principle to viruses of concern in the processing of pharmaceutical drug products derived from biological fluids and cell-culture techniques. Direct flow- and cross-flow filters are complementary techniques for virus removal and may be used either independently or as an(More)
Incorporation of adequate clearance methodologies for viral safety assurance constitutes an integral part of the manufacturing process for plasma-derived biologicals. Filtration, being non-invasive, non-destructive and a <<robust>> mechanism for virus removal is often the method of choice. This paper discusses the virus filter performance characteristics(More)
Breathing circuit filters (BCFs) are used in respiratory and critical-care settings for humidification of air and to limit transmission of respiratory pathogens. Three types of BCFs (Pall BB 25A, BB 100, and HME 15-22) were evaluated (in triplicate) for removal of Mycobacterium species. Filters were challenged with aerosolized Mycobacterium bovis (a(More)
The efficiency of sequential incorporation of two approaches to virus removal, i.e., tangential flow ultrafiltration using the Omega 300K VR Maximate System, and, direct flow microfiltration using the Ultipor VF grade DV50 virus removal filter, was evaluated using bacteriophage phi 6 in Dulbecco's modified Eagle medium (MEM) as the carrier fluid. A combined(More)
  • 1