Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging. Here are seven things to consider while performing your next chromatography viral clearance study.
HIV has been one of the largest public health challenges facing the world in the past few decades. Approximately 36.7 million people were infected with HIV, as reported by the World Health Organization, at the end of 2015. Despite the public attention and large population impacted by this virus, developing a cure for HIV has been particularly difficult. To successfully cure an infected individual the virus would need to be fully eradicated from their body, which is difficult because HIV is extraordinarily good at hiding in a person’s cells. In fact, part of the virus’ replication cycle is to insert itself into the host’s DNA. Once there, HIV appears to be undetectable and it can stay in the cells for the lifetime of the cell. In this state, the virus is termed “latent.”
Accurate flow is important for your chromatography step to provide reproducible results at different scales. For ÄKTA pilot 600 chromatography system, flow and gradient formation is controlled by the UNICORN™ system control software. In this work, flow accuracy was investigated at a combination of different backpressures, flow rates, temperatures, and liquid viscosities.
The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this study, the predefined sanitization method developed for ÄKTA pilot 600 was assessed.
When scaling, you can make better use of existing chromatography columns while avoiding overcapacity. Try this alternative approach to achieve a constant residence time.
Single-use technologies (SUTs) are here to stay. But where we see full single-use upstream processes, downstream is often a hybrid solution. Here’s why SUTs will not completely replace reuse systems in the near future.
Introduced to the pharmaceutical industry decades ago, lipid-based drug delivery systems are the most well-studied and widely utilized technology among all available bioavailability enhancement technologies. Lipid-based drug delivery systems have delivered more than 60 unique drug molecules to market – and counting. Watch this webinar to learn more about the importance of and recent developments in lipid-based drug delivery systems, novel lipid excipients, models, and screening tools for early phase development of lipid-based drug delivery systems, and using mechanistic studies and modeling to predict the impact of lipids on oral absorption.
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.
A comprehensive capsule filter brochure that highlights media options (0.04 μm to 99 μm), including PVDF (SteriLUX® and Steridyne®), PES (STyLUX® and EverLUX®), PP (Chemdyne®), PTFE (Ultradyne®), borosilicate glass microfiber
(Protec®), PP microfiber (ALpHA® and Vangard®), and PP depth (DeltaMax® and DeltaDepth®.)
Nitto Avecia Pharma Services, Inc. corporate vision is “Creating Wonders,” and we take that to heart with each service we provide, priding ourselves in being fast and flexible and knowing full well that our clients require a partner to move in sync. As speed to clinic is crucial to our clients’ success, we offer a seamless package of CMC analytical development and testing as well as manufacturing services from early phase through commercialization.
Catalent Biologics is your one integrated partner with expertise to get your biologic to market faster. We have the passion to help you accelerate, simplify and de-risk your next biologic from development and manufacturing, to fill/finish, clinical supply and commercial launch.