The recent headlines on the millions of Covid-19 vaccine doses lost due to quality control issues may have surprised the media and consumers, but unfortunately, those working in the pharmaceutical industry know losing batches is not a rare occurrence. In a way, this should give us comfort that the quality processes worked, but it also brings attention to one of the core issues plaguing pharmaceutical manufacturing quality control. Quality control (QC) labs lack the automation and digitization of critical functions to keep pace with the demands of today’s modern pharmaceutical manufacturing.
As the CEO of a company that provides solutions to automate and accelerate critical elements of quality control in microbiology labs at global pharmaceutical manufacturers, I know how passionate quality professionals are about their work. They understand the impact they are having on saving lives by ensuring the finished products are free of contaminants. But thousands of these highly qualified professionals across the globe are conducting hundreds of millions of tests every year, testing the air, water, surfaces, personnel and end products, primarily capturing data manually, on a pen and paper! It should be easy for anyone to understand the errors that can occur with this type of process!
The fourth industrial revolution (Industry 4.0) across other industries has shown that automated systems transform assembly lines and workflows by reducing errors and cost while delivering quality improvements. However, for pharmaceuticals, the adoption of automated technologies that improve efficiency, reduce time to detect issues and ensure data integrity can be hindered by the desire to approve investments purely on the basis of traditional labor cost savings and production efficiency gains. Some of the softer, but arguably more important, factors like reduction of errors or investigations, data integrity, improving manufacturing capacity, saving batches of life-saving drugs and vaccines are often underrepresented in the business cases. In many cases, there is no standard “Cost of Quality” business case framework that puts business risk-reduction at the center of the decision process. Some forward-thinking, leading pharmaceutical companies are starting to invest more heavily in automating their QC labs to reduce operating risk and accelerate delivery of medications to patients, but broader adoption is needed to fully impact global supply chains of critical vaccines, therapies, and other medications.
Regulators also recognize automation as a potential area to improve data integrity and investigations. That is one reason why Growth Direct® System has gained strong traction with customers in the US, Europe, and other parts of the world.
Covid-19 vaccine production setbacks have highlighted the need to upgrade the global critical quality and manufacturing infrastructure in order to meet the scale and speed required to ensure these drugs can be made available to everyone around the globe in a timely and safe manner.
I hope the pharma manufacturers, regulators and solution providers rise to the occasion and provide the pharmaceutical manufacturing quality leaders and lab professionals with the support they need to bring lifesaving drugs to the market quickly and safely. Rapid Micro Biosystems is proud to play its role in pharmaceutical QC and stands fully committed to supporting this important industry transformation.
~Robert Spignesi, President and CEO