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.

VIEW OUR PUBLISHED ARTICLES BELOW
Quality Culture:  Getting it Right the First Time

June, 2017 – “Minimum viable product” may work well for software, but pharma needs to get it right the first time, and develop a culture of quality, tied to metrics, and encouraging change where the work actually takes place. This article in Innovation Excellence quotes Tunnell’s Al Riles and Bob Johnson on defining the four components of a quality culture.

Integrating Technology Transfer and Facilities Startup for Biologics

April, 2016 – The key to successful technology transfer and facility startup is in strong project management, and it may make all the difference between a successful launch and one plagued by delays. Careful planning can help avoid the pitfalls often found in transferring processes between facilities. This article in BioPharm International, by Tunnell’s Walter Matzmorr, discusses the complexities inherent in technology transfer, and details how to successfully shorten time-to-market and avoid costly mistakes.

Manufacturing’s True North: The Quality Compass

August, 2015 – Biopharma needs to combine a “culture of quality” with value-added process improvements in manufacturing. Here are key steps and strategies that can make a difference–and deliver bottom-line results.

Quality Agreements for Contract Manufacturers

September, 2014 – A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

State of Quality and Compliance in the Biopharmaceutical Industry

April, 2013 – Have FDA initiatives improved manufacturing quality and patient safety?

Operational Excellence: More Than Just Process Improvement

October, 2013 – By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.

Through the Lens of Lean

October, 2012 – Lean may have been designed for manufacturing, but it can also transform quality control labs.

Connecting QbD, Knowledge Management and Supplier Quality Management

November, 2012 – Understanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost.

Risk Based Decision Making

March, 2012 – Focusing on how risk affects the entire organization can improve the business bottom line.

Reduce Analytical Testing and Costs Without Compromising Compliance

July, 2012 – Unnecessary analytical testing can lead to unnecessary costs.

QbD:  The Case for Change

March, 2011 – Executive management leadership is essential in the effective implementation of QbD.

QbD:  The Case for Change (Part 2)

May, 2011 – A rigorous cost benefit assessment can help to chart a cost-effective path forward.

QbD:  Time to Market 

Dec., 2011 – Are you factoring in the potential cost of unexpected failure?

Supply Chain Transformation:  Strategic Necessity for the Life Sciences 

March, 2011 – New supply chain challenges, including counterfeits, are forcing companies to act in different ways to secure produce safety.

Impact of cGMP on Supply Chain 

July, 2011 – Incorporating regulatory requirements into the product life-cycle plan is crucial for supply chain security and patient safety.

Keys to a Successful Technology Transfer 

Feb, 2011 – Poor planning and misguided implementation when conducting technology transfer can lead to problems with budget, scheduling, compliance and supply.