Orthogonal Technologies for Viral Safety
Many biopharmaceutical therapies, such as mAbs and blood plasma factors, are produced using biological materials. This carries the risk that microorganisms may be unintentionally introduced into the manufacturing process and contaminate the product; these include (amongst others) bacteria, mycobacteria, transmissible spongiform encephalopathy (TSE) agents and viruses, called adventitious agents. In addition to extensive testing during the manufacturing process, in order to demonstrate the absence of adventitious agents, it has to be proven that the manufacturing process is capable of removing them.
Introduction of multiple complementary and validated viral clearance steps in the manufacturing process, which inactivate and/or remove potential viral contaminants, are of paramount importance in developing new processes for biopharmaceutical drug manufacturing.
An orthogonal approach to viral safety in bioprocessing involves different but complementary techniques, which work together to reduce the risk of virus contamination reaching the final drug product. This may include retentive processes such as virus filtration, adsorptive processes such as chromatography, and inactivation processes under certain conditions such as low pH; that destroy the virus particles. Regulatory bodies like the European Medicines Agency (EMA) and Food and Drug Administration (FDA) require that a minimum of two orthogonal steps for viral clearance need to be employed in the manufacture of therapeutic proteins derived from biological materials. Pall can provide technology for three orthogonal step options in either batch or continuous processing mode.
Pall Integrated Solutions
With over 20 years of experience in providing automated systems for viral clearance, Pall can provide the knowhow and engineering excellence for an automated system for a single orthogonal viral clearance step, an optimized downstream processing train, or a complete end-to-end solution. Whether it would be a traditional stainless-steel approach, a single-use approach, continuous or hybrid, our integrated solutions can help you find the best choice for viral clearance in your bioprocessing journey.