See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.
Biomolecules are becoming more complex. Bio-Rad’s newest hydrophobic AEX chromatography resin, Nuvia aPrime 4A, is designed with distinctly balanced modes for better interactions to purify your toughest targets. Now you can triumph with even the most challenging biomolecules. Learn more about Nuvia aPrime today and experience a wider design space delivering high purity and yield.
The development of a new product or service is better done as a collaboration between the developer and the potential end user(s). Systems developed in isolation often end up answering questions no one has ever asked, or fail to develop a full solution. With that in mind, this article discusses the product development cycle of a system for bulk filtration of Active Pharmaceutical Ingredients (APIs), how this development progressed from generation one to two and the lessons learned along the way.
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
The viral vector market is highly active, and the interest in production technologies is driven by recent approvals in cell and gene therapy. Here, insights around the challenges in viral vector manufacturing are shared so that a scalable and cost-efficient process suitable for GMP manufacturing environments can be obtained.
A client was exploring the possibility of re-purposing an internal collection of antifungal CYP51A1 inhibitors for targeting cancers. GVK BIO was commissioned to enable the such project. Learn how a CYP51A1 inhibitor screening assay using the RapidFire HTMS method was deemed to be optimized, and screening of client compounds was enabled with an acceptable throughput and in a cost-effective manner. This project then went on to yield high potency compounds for the client which allowed them to further their drug discovery plans.
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.
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.”
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 offers a seamless package of CMC analytical development and testing as well as manufacturing services from early phase through commercialization.
Catalent Biologics is an integrated partner with expertise to get a biologic to market faster. The company has the passion to help its partners accelerate, simplify and de-risk their biologic therapies -- from development and manufacturing, to fill/finish, clinical supply and commercial launch.
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.
The new standard in automation and reliability for drug discovery and development.