Search results for " viral clearance" in Articles / App Notes
Article
Updating Viral Clearance for New Biologic Modalities
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has become increasingly challenging based upon the increasing range of product classes emerging. Because virus…
Article
Selecting the Right Viral Clearance Technology
The success of viral clearance depends on the selection of appropriate methods that ensure the removal or destruction of any viruses without affecting the target protein. Several factors must be consi…
Article
Viral Clearance Challenges in Bioprocessing
Even with guidance, however, demonstrating an appropriate level of viral clearance can be challenging for biologics manufacturers.
Upstream viral clearance
Using media with a low level of viral …
Article
Putting Viral Clearance Capabilities to the Test
The model viruses used, and the number of steps investigated for viral clearance capacity, should be related to the risk assessment and product-specific regulatory guidance, says Horst Ruppach, direct…
Article
Viral Clearance: 7 Chromatography Column Considerations
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 conside…
Article
Fundamentals of Viral Clearance Studies with a Focus on Chromatography
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
Application of Quality by Design to Viral Safety
…viruses as well as the assurance that the manufacturing process can provide effective and consistent viral clearance.
Figure 1: A quality-by-design approach to a product involves an understanding…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Product safety and quality by design (QbD)
Traditionally, product safety has relied on the incorporation of three key measures into the manufacturing process: selection, testing, and viral clearan…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
The biotechnology industry utilizes this technology to ensure viral clearance in downstream processing. Currently, optimized filters are considered for the filtration of thermo-sensitive raw materials…
Article
Development of Purification for Challenging Fc-Fusion Proteins
As tested on three Fc-fusion proteins, this process demonstrates high process yield, improved clearance of HMWs and LMWs, and efficient reduction of host cell proteins (HCP) and DNA as well as robust …