Speed Isn’t the Only Advantage of Contract Manufacturing Software

According to Sarah Stinton, manufacturing chemist for Almac Sciences, speed is the biggest advantage of modern contract manufacturing software, and it has made all the difference. But speed isn’t the only advantage.

Almac Sciences is a leading provider of personalized medicines, but that was not always the case. This elite contract development and manufacturing organization (CDMO) that specializes in pharmaceuticals has a longstanding reputation for delivering high quality products according to very difficult specifications. However, when the emerging market of peptides for use in precision and personalized medicines caught their attention several years ago, they realized their paper-based manufacturing operations management would prevent them from competing in that space.

Peptides are midsized molecules that are ideal for use in personalized medicines and cancer vaccines. However, traditional manufacturing operations that have characterized the industry for decades, including legacy manufacturing execution systems (MES), are not ideal for working with peptides. The production cycles for these novel products have to be reduced from months to weeks, according to Alistair Hay, VP for peptides at Almac Sciences.

Implementing Electronic Batch Records Was the Right Step

How did they do it? Adopting a modern and flexible manufacturing execution system solution, MasterControl’s innovative Manufacturing Excellence, was a major step, but not necessarily the first or the last. Almac Sciences was able to adequately prepare key personnel because the software was easy to implement and use. After implementation, they were able to use the electronic batch records (EBRs) built into MasterControl’s contract manufacturing software to develop innovative processes necessary to quickly deliver personalized medicines in a time-sensitive clinical manufacturing market. This digital transformation in manufacturing has paid off, with electronic batch records now enabling the company to manufacture products 80-100 times faster than they could using conventional manufacturing tools, according to Hay.

“It’s not apparent until you adopt an electronic system that you’ve been constrained by paper systems,” Hay concludes. “Just through the act of adopting the [electronic] system, you see new ways of working, new opportunities that can improve compliance and effectiveness and save you time and resources.”

In-Line Quality is a Key Advantage of Connected Contract Manufacturing Software 

Successful rapid-release manufacturing for precision products requires coordination with quality teams in order to have quick and agile cycle times and still keep standards high. Integrating quality assurance roles and tasks throughout the quick product life cycle is one of the key advantages of Manufacturing Excellence that makes it possible for Almac Sciences to deliver the complex products they are known for. Customers and regulators alike have been pleased with their on-spec and on-time products.

Because of its success with Manufacturing Excellence, the company has immediate plans to expand its operations and envisions long-term commercialization to reach its overarching goal of advancing human health. Read this new case study from MasterControl to find out more about Almac Sciences’ digital transformation in manufacturing and how they continue making quality a competitive advantage in manufacturing.