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Maintaining Quality As a Scaling Contract Manufacturer

It’s an uphill task for Contract Development and Manufacturer Organizations (CDMOs) to ensure product quality at the rapid pace demanded by customers, especially when they must deal with safety, control, and regulatory regimes in fields such as pharmaceuticals, biotech, and other areas of the life sciences.

This task requires checking the quality of multiple changing product lines while managing the sourcing of materials and logistics to minimize the risks of supply shortages in a challenging geopolitical environment. And in the end, these businesses still need to meet the customer’s time and quantity requirements.

Contract Manufacturing - ERP Built for the Life Sciences Industry | Download the PDF

By maintaining production quality and speeding up time to market, a CDMO can capitalize on the growth of the life sciences industry driven by the COVID-19 pandemic. Valuates Reports has projected that the size of global CDMO market sizewill reach US$159.5 billion by 2027, up from $8 billion in 2020—a compound annual growth rate of roughly 10 percent.

 

Accelerate Digitization from the Shop Floor to the Boardroom

In order to make production lines flexible and maintain quality, a CDMO needs to connect all production process digitally, from the shop floor to the dashboard for decision-makers. This can be achieved by the deployment of a modern enterprise resource planning (ERP) system. 

An ERP integrates data and increases visibility for everyone in the company. ERP integrates with the Internet of Things (IoT) and artificial intelligence, which help to monitor, detect, notice, and predict any incident and error in business processes.

With real-time data, you can tackle problems in business processes before products are available and distributed in the market. That’s crucial, because in the life sciences field, poor product quality or contamination of ingredients can lead to medical side effects or loss of life. 

Production errors can be reduced with a fully integrated digital platform where standard operating procedures, 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 cost of contamination is exemplified by a crisis that occurred at Emergent BioSolutions’ plant in Baltimore in April, 2021. As the New York Times reported, a production error at the facility in confused components of Johnson & Johnson and AstraZeneca’s COVID-19 vaccines, both of which were being made at the plant. 15 million vaccine doses were spoiled, and the case led to lawsuits from shareholders, as well as other reputational losses for Emergent.

In the race to keep up with demand, losing quality control visibility can threaten and violate compliance. Just as important, by keeping products off the market, these problems prolong waiting times for patients who need life-saving products. Digitization streamlines quality and compliance, and the outcome is measurable. By putting off digital transformation, CDMOs will earn in the short term at the cost of quality. 

 

Adaptability is Critical for Future Growth

Advanced technologies and modern machinery provide CDMOs the flexibility to support existing and potential customers. Cloud-based ERP with modular features enable business to scale up to meet business growth in every step of business evolution and cover different geographic regions with different laws, tax and financial systems, and currencies.

SAP Business ByDesign is designed for use across the globe, and we offer a preconfigured industry solution version of Business ByDesign that support the specific needs of CDMOs. This can ensure the success of deployments, minimize potential for project failure, reduce the need for modification, and make it easier to comply with regulations in multiple countries. Pre-validated ERP software can dramatically cut down on the cost of configuration and verification.

For instance, the Center for Breakthrough Medicines (CBM), a CDMO focused on manufacturing advanced therapies, drove rapid growth by deploying an ERP system to support its continued expansion and providing the highest level of responsive service to customers.

“With a validated and scalable ERP system, the company is advancing its vision to build the world’s largest cell and gene therapy manufacturing and testing facility and enable the rapid development and delivery of groundbreaking treatments for patients,” said Peter Carbone, chief operating of CBM

 

Quality is a Differentiator

Investing in technology delivers increased operational efficiency and agility, and can reduce downtime. An ERP platform can improve your ability to predict and adjust to facility and supply changes, reduce shop floor data input errors and data integrity issues, shorten the quality review period after production is complete, reduce total deviations related to data integrity issues, and accelerate incident resolution.

For CDMOs, quality is a competitive differentiator, and it’s important to stay ahead. Otherwise, you could be fighting a losing battle in volatile situation. Prioritizing quality is a winning strategy. What if you face quality issues during the manufacturing process? You won’t just fall behind your rivals; you could face a damaged reputation well as lawsuits from customers and regulators, and that’s not even considering the potential loss of life.

Learn more about how Navigator can help CDMOs roll out ERP for their business.

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