Application of machine learning methods to pathogen safety evaluation in biological manufacturing processes
The production of recombinant therapeutic proteins from animal or human cell lines entails
the risk of endogenous viral contamination from cell substrates and adventitious agents from …
the risk of endogenous viral contamination from cell substrates and adventitious agents from …
The current state of Bayesian methods in nonclinical pharmaceutical statistics: Survey results and recommendations from the DIA/ASA‐BIOP Nonclinical Bayesian …
The use of Bayesian methods to support pharmaceutical product development has grown in
recent years. In clinical statistics, the drive to provide faster access for patients to medical …
recent years. In clinical statistics, the drive to provide faster access for patients to medical …
Twenty plus years of data demonstrating virus filtration as an effective and robust step for large virus removal
B Stanley, V Holmes, R Manzari… - PDA Journal of …, 2022 - journal.pda.org
Virus filtration has been demonstrated to be an effective and robust dedicated viral
clearance step that is used in biopharmaceutical manufacturing processes. Here we present …
clearance step that is used in biopharmaceutical manufacturing processes. Here we present …
Proceedings of the 2019 Viral Clearance Symposium, Session 4: Viral Clearance Strategy and Process Understanding
D Roush, J Blümel - PDA Journal of Pharmaceutical Science and …, 2022 - journal.pda.org
This article describes a summary of discussions and outcomes from the 2019 Viral
Clearance Symposium Session 4 on the utilization of knowledge, both from within and …
Clearance Symposium Session 4 on the utilization of knowledge, both from within and …