The Central Role For Contract Manufacturers In Developing Control Strategy For Gene Therapy Products
- October 2018
- Cell and Gene
Tunnell’s Julia O’Neill discusses statistics, chemical engineering and the curse of dimensionality.
Published Articles
Tunnell’s subject matter experts have written a number of informative pieces. Here are a sampling of articles that have been published in leading industry publications.
Data Integrity Deviations and Shop Floor Quality
- June 2018
- Pharmaceutical Online
Kip Wolf explains why there is no “quick fix” for quality – it remains a journey of continuous improvement.
PAI Readiness – A Journey, Not an Event
- June 2018
- Contract Pharma
Walter Matzmorr discusses the cross functional process of planning for a Pre-Approval Inspection.
Using Lean Strategy to Improve Efficiency in Pharmaceutical QC Labs
- March 2018
- Bioprocess Online
Tunnell Consultants Greg Anthos and Scott Myers explain how a company reduced its 15-day throughput time by 30% within 3 months.
Where EDMS Fails: Data Integrity Pitfalls to Avoid in Metadata for Life Sciences Products
- March 2018
- Pharmaceutical Online
Tunnell’s Kip Wolf explains how firms that create and manage electronic documents can improve compliance.
Losing Sight of the Intended Purpose of Specifications Has Consequences for the CMO-Sponsor Relationship
- March 2018
- Life Science Leader
Mar. 2018 – Julia O’Neill discusses current practices for specification-setting in the pharmaceutical industry.
Why You Should Engage With Regulatory Early in Product Development
- March 2018
- Bioprocess Online
Tunnell Principal, Kati Abraham, explains the importance of early regulatory engagement.
Cheating In The Lab: 3 Data Integrity Pitfalls to Avoid in Laboratory Operations
- January 2018
- Bioprocess Online
Tunnell Managing Consultant, Kip Wolf, discusses observations of CGMP violations involving data integrity.
Information Management Strategies to Improve Data Integrity During M&As
- November 2017
- Life Science Leader
Tunnell Managing Consultant, Kip Wolf, discusses the challenges to M&A integration and maintaining business continuity, transferring appropriate knowledge, and transferring information assets.
In Defense of the Anti-Generic
- June 2017
- Pharma Manufacturing
This article in Pharmaceutical Manufacturing quotes Tunnell’s Scott Myers on the role of authorized generics in today’s competitive generics marketplace.
Quality Culture: Getting it Right the First Time
- June 2017
- Innovation Excellence
“Minimum viable product” may work well for software, but pharma needs to get it right the first time, and develop a culture of quality,
Integrating Technology Transfer and Facilities Startup for Biologics
- April 2016
- BioPharm International
The key to successful technology transfer and facility startup is in strong project management, and it may make all the difference.