David Schoneker

home / authors / david-schoneker

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

Articles

Beige cosmetic or make up powder isolated on white. | Image Credit:©triocean – stock.adobe.com

Understanding Excipient Characteristics to Ensure Robust Continuous Manufacturing

Krizia M. Karry;Brian Carlin;Nigel Langley;R. Christian Moreton;David Schoneker;Katherine L. Ulman;Joseph Zeleznik
June 13th 2024

Key information is needed for excipients and their potential impact on continuous manufacturing processes.

Mitigating the Risk from Excipient Variability

Mitigating the Risk from Excipient Variability

Brian Carlin;George Collins;R. Christian Moreton;David Schoneker;Jennifer Putnam;Joseph Zeleznik;Katherine Ulman;Stacey Bremer
August 3rd 2022

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Understanding Concomitant Components in Pharmaceutical Excipients. Image: monsitj - stock.adobe.com

Understanding Concomitant Components in Pharmaceutical Excipients

Jennifer Putnam;Katherine L. Ullman;Priscilla Zawislak;David Schoneker;George Collins;Douglas G. Muse;Brian Carlin;Joseph Zeleznik;R. Christian Moreton
February 3rd 2021

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.

Latest Updated Articles

Buy, Sell, Hold: Cell and Gene Therapy
Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com
Published: September 10th 2024 | Updated: September 18th 2024
CPHI Milan Announces 2024 CPHI Pharma Award Finalists
Published: October 28th 2024 | Updated: November 22nd 2024
Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development
Operator work on infusion pharmaceutical industry | Image Credit: © xmagics - © xmagics - stock.adobe.com
Published: November 6th 2024 | Updated: November 22nd 2024
Automate Aseptic Filling: Closing the System at Full Modularity
Two scientists wearing lab coats and safety glasses analyzing data displayed on a computer screen in a laboratory setting | Image Credit: © NCST Studio - © NCST Studio - stock.adobe.com
Published: November 5th 2024 | Updated: November 22nd 2024
Untethered Data: Unifying and Contextualizing Drug Discovery Data
Medium shot of female process supervisor in lab coat pointing at equipment controlling production quality with African American male manufacturing technician, working in protective suit at factory | Image Credit: © Seventyfour - © Seventyfour - stock.adobe.com
Published: November 8th 2024 | Updated: November 22nd 2024
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification