Use of MMV as a single worst-case model virus in viral filter validation studies

E Gefroh, H Dehghani, M McClure… - PDA journal of …, 2014 - journal.pda.org
Typical platform processes for biopharmaceutical products derived from animal cell lines
include a parvovirus filtration unit operation to provide viral safety assurance of the drug …

Nanofiltration as a robust method contributing to viral safety of plasma‐derived therapeutics: 20 yearsʼ experience of the plasma protein manufacturers

NJ Roth, HO Dichtelmüller, F Fabbrizzi, E Flechsig… - …, 2020 - Wiley Online Library
Background Nanofiltration entails the filtering of protein solutions through membranes with
pores of nanometric sizes that have the capability to effectively retain a wide range of …

The effects of flux on the clearance of minute virus of mice during constant flux virus filtration

R Fan, F Namila, D Sansongko… - Biotechnology and …, 2021 - Wiley Online Library
Constant flux virus filtration experiments were conducted to evaluate minute virus of mice
retention behavior of four commercial virus filters for continuous bioprocessing applications …

A novel approach to achieving modular retrovirus clearance for a parvovirus filter

J Stuckey, D Strauss, A Venkiteshwaran… - Biotechnology …, 2014 - Wiley Online Library
Viral filtration is routinely incorporated into the downstream purification processes for the
production of biologics produced in mammalian cell cultures (MCC) to remove potential viral …

Virus elimination during the purification of monoclonal antibodies by column chromatography and additional steps

PL Roberts - Biotechnology progress, 2014 - Wiley Online Library
The theoretical potential for virus transmission by monoclonal antibody based therapeutic
products has led to the inclusion of appropriate virus reduction steps. In this study, virus …

Serial virus filtration: A case study evaluating the product‐dependent impact of control strategies on process efficiency

J Kozaili, A Shah, D Robbins, N Brinkman… - Biotechnology …, 2023 - Wiley Online Library
The production of biopharmaceutical products carries an inherent risk of contamination by
adventitious viruses. Historically, these manufacturing processes have incorporated a …

Suitability of a generic virus safety evaluation for monoclonal antibody investigational new drug applications

P Sipple, T Nguyen, K Patel, N Jaffe… - Biotechnology …, 2019 - Wiley Online Library
Biologics produced from CHO cell lines with endogenous virus DNA can produce retrovirus‐
like particles in cell culture at high titers, and other adventitious viruses can find their way …

Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP Unit Operations—Virus Filtration/Inactivation

TR Kreil, D Roush - PDA Journal of Pharmaceutical Science and …, 2018 - journal.pda.org
The manufacturing processes of biological medicinal products are expected to be capable of
removing and/or inactivating viruses, to primarily provide for adequate safety margins to …

Proceedings of the 2019 Viral Clearance Symposium, Session 6: Virus-Retentive Filtration

S O'Donnell, G Bolton - PDA Journal of Pharmaceutical Science …, 2022 - journal.pda.org
Manufactures of therapeutic biological products are required to incorporate downstream unit
operations that can inactivate or remove potential viral contaminants from the manufacturing …

Virus filtration using small pore virus filter in downstream processing of biotherapeutic products: The effect of operating pressure

N Liu, T Xu - Biologicals, 2023 - Elsevier
Virus filtration is a robust and effective method to remove potential virus contaminants.
Planova 20 N, a virus filter form Asahi Kasei Bioprocess, has been widely used in the …