Maintaining Quality in the Fast-Paced Contract Manufacturing Industry

Contract manufacturing and contract development manufacturing organizations (CMOs and CDMOs) remain in the spotlight for helping to make it possible to produce COVID-19 vaccines, which are needed around the world. As of mid-May, about 9.7% of the world’s population has been vaccinated against COVID-19, which equates to 1.48 billion doses.¹ With all eyes on the contract manufacturing industry, increased scrutiny brings the issue of maintaining quality to the forefront.

It’s a significant challenge to manufacture a product at the quick pace demanded by customers while maintaining impeccable quality. Managing multiple, changing product lines increases complexity and the difficulty of maintaining speed as well as quality. With a modern manufacturing solution, CMOs and CDMOs can prioritize both.

Costs of Compromising Quality

Emergent BioSolutions was rushing to manufacture vaccines for Johnson & Johnson and AstraZeneca at their plant based in Maryland, and a production error led the CDMO to scrap the materials for up to 15 million Johnson & Johnson vaccine doses.² In April 2020, the U.S. Food and Drug Administration (FDA) issued a Form 483, which noted several quality control issues at Emergent’s manufacturing site that led to the cross contamination of materials including a lack of written procedures and inadequate operator training.³

Now the FDA is questioning whether or not the equivalent of 70 million doses from the same plant can be distributed, and executives from Emergent BioSolutions will testify before the House Select Subcommittee on the Coronavirus.^4,5

No CMO or CDMO wants to find themselves in a similar position. In the race to keep up with demand, losing sight of quality can jeopardize compliance. More importantly, it can result in in longer wait times for people who need life-saving products.

Improve Quality with Digitization

The likelihood of encountering problems like those experienced by Emergent BioSolutions (i.e., lack of written procedures and inadequate training), can be greatly reduced with a fully integrated, digital platform where standard operating procedures (SOPs), training documents, and production records can be managed from a central location. By operating from a connected system, it is possible to embed quality into every stage of production.

The National Institute of Standards and Technology reported that investing in advanced technology delivers benefits such as:

• Increased operational efficiency and agility.
• Reduced downtime.
• Improved ability to predict and adjust to facility and supply changes.⁶

Customers who digitized with MasterControl’s platform solution can attest to the significant quality improvements that are possible through digitization:

• A contract manufacturer reduced shop floor data input errors and data integrity issues by 90%.
• The improvements made by the contract manufacturer mentioned above helped shorten the quality review period from 10-15 days after production completes to a mere three days – a 75%-80% reduction.
• A contract packager reduced total deviations related to data integrity issues by 25%-30%.
• A contract development and 503B facility is working toward eliminating 90%-100% of data entry errors, and they plan to accelerate incident resolution by moving from a paper to digital solution.

Digitization streamlines quality and compliance, and the results are tangible. By putting off digital transformation, organizations are doing so at the cost of quality.

The Time to Digitize is Now

For CMOs and CDMOs, quality is a competitive differentiator, and it’s important to stay ahead so you don’t risk falling behind – the time to digitize is now.

Emeritus Professor for the London School of Economics, Leslie Willcocks conducted research on digital transformation and found that once a company falls behind, there may not be a way to recover.

“Our evidence, consistent with other studies, shows that being slow to adopt digital technologies may reduce risk in the short term, in terms of cost, talent, and time, but it builds growing business risk and diminished competitiveness in the long term. This trend will be repeated and magnified by the growing adoption of emerging technologies, such as automation and AI over the next five years. Put bluntly, the competitive advantage of ‘leader’ firms could become irreversible,” she reported.⁷

For as ominous as that sounds, this presents an opportunity to digitize today and gain a considerable edge over competitors, but the timing is critical. No CMO or CDMO can afford to be playing catch up, especially when it could be a losing battle and a focus on quality is a winning strategy.

References

1. More Than 1.48 Billion Shots Given: Covid-19 Tracker, Bloomberg, May 18, 2021.
2. Emergent’s Baltimore plant flagged for quality control concerns last April, FDA report reveals, Fraiser Kansteiner, Fierce Pharma, April 9, 2021.
3. Form 483 for Emergent Manufacturing Operations Baltimore, LLC, Food and Drug Administration, April 2021.
4. Baltimore Vaccine Plant’s Troubles Ripple Across 3 Continents, Chris Hamby, Sharon LaFraniere, and Sheryl Gay Stolberg, The New York Times, May 12, 2021.
5. Emergent BioSolutions CEO, founder head for the Hill as Congress probes production contracts, errors, Fraier Kansteiner, Fierce Pharma, May, 12, 2021.
6. 7 Manufacturing Digitization Challenges – and How to Overcome Them, Celia Paulson, National Institute of Standards and Technology, June 25, 2020.
7. How to Succeed At Digital Transformation, Leslie Willcocks, Forbes, January 29, 2021.