Evaluating how much a process step contributes to viral clearance is an essential part of process validation in order to be sure you are manufacturing safe drugs. Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
Understand the several disadvantages of traditional methods of conducting bulk fill operations and learn how an automated and integrated single-use system for final bulk filtration can help you overcome those obstacles.
Early collaboration and open communication between upstream and downstream are crucial to ensure a consistent end-to-end bioprocess.
Intensifying or simplifying your bioprocess can mean more product, shorter manufacturing times, or lower costs –understanding what matters most is key to making the right decisions.
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
This video introduces Singota Solutions, a CDMO focused on getting products to patients faster by being agile, accountable and transparent. A team of industry experts help virtual to large pharma clients reach preclinical and clinical milestones faster with shorter lead times and agile onsite operations. Services in formulation development, finishing and supply chain support Singota’s flagship aseptic filling operations. A gloveless robotic isolator provides highly repeatable and precise filling for high value drug products.
Hear how an adaptive and evolving platform of proven and novel technologies enables biomanufacturers to successfully accomplish their bioprocessing goals through either intensified, connected or continuous bioprocessing.
As the industry is looking to increase speed to market, reduce manufacturing resources and increase product safety, there has been a push to implement single-use technologies. Combining both SPTFF and single-use technology can be a powerful tool for the efficient manufacture of biologics.
Where sterility will be claimed, regulatory agencies worldwide require that the integrity of sterilizing-grade filter(s) is verified before and after use to ensure filter performance. This webinar highlights best practices and key considerations for performing filter integrity tests to give you a better understanding of how to design a robust integrity test operation in your own facility.
Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.
Is your protein unable to bind efficiently to your resin? If you are performing flow-through (FT) purification, monomer recovery could be poor in the flow-through fraction due to nonoptimal conditions, a nonideal resin, or both.
Are mild pH conditions not eluting your antibody from your resin? Are harsh pH conditions causing dimers and aggregates to form and co-elute with monomers? These issues could be leading to low monomer purity and recovery.
Nuvia aPrime 4A Hydrophobic Anion Exchange Resin possesses the optimal balance of ion exchange and hydrophobic interactions to deliver simultaneous purity and yield of therapeutic proteins and monoclonal antibodies that are difficult to purify.