ValSource Valid Insights Quarterly Newsletter’s Q2 issue

An article titled, “Risk- And Science-Based Media and Buffer Mixing Validations,” written by ValSource Senior Consultants Igor Gorsky and Beth Fulton was published in the March/April 2024 issue of Pharmaceutical Engineering.

A recent article titled, “A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies,” written by ValSource Senior Consultants Darius Pillsbury and Tiffany Baker was published in Cell & Gene, Outsourced Pharma, and Bioprocess Online.

This is the first in a series of three articles that will be published.

The following article published in Cell & Gene by ValSource Senior Consultants Amanda McFarland ; Patrick Mains; and Consultant Theo Zacharatos; discusses the importance of having a robust cross contamination program.

In the recently published, “Process Validation in Manufacturing of Biopharmaceuticals, 4th Edition,” ValSource Senior Consultants Tiffany Baker and Patrick Mains co-authored a chapter titled, “Principles of Quality Risk Management for Validation.” The book was co-edited by ValSource COO Hal Baseman.

ValSource Business Unit Manager Kelly Waldron, PhD, was a lead author of the Quality Risk Management (QRM) Chapter in this publication.

By ValSource Business Unit Manager Kelly Waldron, PhD; and Senior Consultant Patrick Mains; and Consultant Beth Fulton.

This article highlights some best practices for the use of risk registers in pharmaceutical manufacturing.

By ValSource Senior Consultants Amanda McFarland and Ryan Murray

This article published in Outsourced Pharma discusses ICH Q9R1 Quality Risk Management regarding the topic of formality and the role of uncertainty in risk tool selection.

By Christine Craig, ValSource Consultant (co-author)

A recently published paper titled, “Assessing the risk of a clinically significant infection from a microneedle array patch (MAP) product,” co-authored by ValSource Consultant Christine Craig, identifies some of the key product and patient-specific factors that may contribute to the risk of infection from a MAP product and provides expert opinions in the context of guidance from regulatory authorities.

By ValSource Consultants Beth Fulton and Angelica Welch

A recent article by ValSource Consultants Beth Fulton and Angelica Welch published in the PDA Journal of Pharmaceutical Science and Technology outlines a risk-based approach for navigating remediation (non-routine sanitization) of contaminated affinity-based resins.