病毒过滤器

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• Article: Synthetic Depth Filters as a Platform Approach for Virus Filtration

  This article explores using a synthetic depth filter as a prefilter for the Viresolve^® Pro Device, enabling rapid process development and enhanced filter capacity in recombinant protein and mAb purification.

• Data Sheet: Viresolve^® Pro

  Proven viral safety solution designed to provide the highest levels of retention assurance and productivity.

• Product Guide: Viresolve^® Pro Solution Prefilter Selection Guide

  Membrane filtration is essential in biologic production, but impurities can hinder filter efficiency. Prefilters improve filter capacity and consistency by removing aggregates, especially in monoclonal antibody processes. The guide offers criteria for selecting prefilters to optimize Viresolve® Pro Device performance.

• Poster: Quality by Design (QbD) Approach to Virus Filtration Operations

  Quality by Design (QbD) formalizes product quality by identifying critical process parameters (CPP) that influence key quality attributes (CQA), such as virus retention in filters. By understanding and controlling these parameters, QbD ensures consistent virus reduction performance in biomanufacturing.

• Brochure: Viral Safety Assurance: Prevent, Detect, Remove

  Viral safety in biomanufacturing follows the "Prevent, Detect, Remove" approach. It includes selecting and treating raw materials to prevent viral contamination, testing for virus presence, and using purification and filtration methods downstream to eliminate viruses.

• App Note: How Baseline Studies Can Ensure Successful Virus Filtration Spiking Studies

  Demonstrating the viral clearance capabilities of specific unit operations in downstream processing is a key component of regulatory submissions for biopharmaceuticals. While most virus filters provide robust viral clearance across a broad range of conditions, there are numerous artifacts that can limit throughput on filters such as the Viresolve^® Pro Device

• Tech Note: Considerations for Use of the Viresolve^® Pro Micro 40 Scaling Tool

  The Viresolve^® Pro Micro 40 Device, designed for small-scale virus filtration and viral clearance studies, offers robust parvovirus retention comparable to larger devices. Replacing the older Micro Device, the new kit (Catalogue Number VPMKVALNB9) includes 9 devices across 3 lots, suitable for process development and optimization.

• Application Note: Virus Retention Performance of Viresolve^® Pro Devices under a Range of Processing Conditions

  This document outlines virus filtration retention using Viresolve^® Pro devices, adhering to the Quality by Design (QbD) terminology for improved process understanding. It consolidates virus retention results from Viresolve^® Pro devices and aims to help biologics manufacturers understand the factors affecting device performance.

• Application Note: Multi-tier Approach to Assuring Virus Retention and Integrity of Viresolve^® Pro Devices

  Biopharmaceutical manufacturers must characterize key process steps for their ability to clear viruses. The entire manufacturing process is qualified to achieve a cumulative virus reduction factor, essential for documenting virus safety. A virus retentive filter is commonly used in these processes to ensure a robust and effective virus clearance step.

• Application Note: Scalability of the Viresolve^® Pro Solution Using the Micro 40 Scaling Tool

  The Viresolve^® Pro Solution includes devices for virus filtration that scale linearly from process development to production. The Viresolve^® Pro Micro 40, designed for smaller-scale evaluations, mirrors the construction of larger devices. This report highlights the consistent scalability and performance of the Viresolve^® Pro devices across various scales.

• Article: Virus Filtration Process Development Optimization

  The Key to a more efficient and cost-effective step.

• Flyer: Viresolve^® Pro Solution: Robust Productive, Proven

  The Viresolve^® Pro Solution is tailored to meet specific needs, offering robust, productive, and proven virus filtration performance. It leads the market with exceptional retention assurance and productivity. Key features include high flux and capacity, consistently high virus retention, easy scalability, usage, and integrity testing. Additionally, it provides multilevel quality assurance and enhances process economics.