MasterControl Congratulates Customers Recognized as 2023’s Leading CDMOs

Earlier this year, Outsourced Pharma Magazine, Life Science Leader Magazine, and Industry Standard Research (ISR)¹, collaborated to celebrate the CDMO Leadership Awards. In its 12th year, the awards focus on core competencies such as capabilities, compatibility, expertise, quality, reliability, and service to distinguish organizations that are leading the industry.

Notably, contract development and manufacturing organizations (CDMOs) have become critical to the delivery of new therapies. According to an article from EY-Parthenon, CDMOs have increasingly become leaders of innovation and are covering more areas of the pharmaceutical business, not only manufacturing, but also adding additional revenue streams. Additionally, they are setting a clear course toward technology leadership, and thus are expected to become even more important over the next decade.²

For pharma organizations, the process for selecting outsourcing partners is time consuming and complex. To support the process, Life Science Leader and Outsourced Pharma developed the CDMO Leadership Awards in 2011, which are awarded based on customer feedback. ISR conducts market research and selects leading CDMOs based on feedback from companies that utilize outsourcing services.

Congratulations to the MasterControl customers that were honored in 2023: Samsung Biologics, FUJIFILM Diosynth, WuXi Biologics, Almac Group, Thermo Fisher Scientific, Corden Pharma, Cambrex, Catalent, Evonik, and Rentschler Biopharma.

Technology Driving Innovation

CDMOs that want to get ahead in their industry and garner more business opportunities can look to digitization in manufacturing to help drive them toward that goal. Life sciences manufacturers face a host of challenges when it comes to managing all the necessary process requirements, and this is amplified when paper is part of the equation. Paper-based processes are prone to error, which can impact several areas such as time to market, quality control, and maintaining compliance. CDMOs are constantly managing changing product lines and supply chain constraints while maintaining compliance with strict regulations. Paper-based processes that can slow manufacturing and quality reviews aren’t compatible with a high-performance operation.

Contract Manufacturing Software and Quality Control

Delivering products of the highest quality is paramount for a CDMO. With manufacturing software, managers can be assured that every data entry point is captured and within specification. For example, an electronic batch record will prohibit operators from moving to a new step before the previous step is completed. It will also alert operators if data is missing during production. Additionally, when building a production record, parameters can be set for fields within the record. For example, if a temperature or humidity reading must be within a certain range, any data entered outside that range will alert the operator to an out-of-spec entry, which can be corrected or managed as needed in real time. This software functionality assists the operator in achieving right-first-time production. CMDOs can be confident that processes are followed and quality standards are being met.

Contract Manufacturing Software and Compliance

Whether it’s for a regulatory audit, customer audit, or internal audit, CDMOs must maintain complete records. One of the issues cited most often during an audit is data integrity, and implementing software solutions can reduce data integrity errors significantly. MasterControl customers have reported mitigating data integrity errors by 90% or more when using the Manufacturing Excellence software solution. Additionally, if a line operator whose training has lapsed attempts to work on a digital production record, the system will alert them that training is out of date and prohibit them from completing the task. Even better, the operator can launch training from the tablet, complete it, and proceed with production.

Contract Manufacturing Software and Speed

When searching for manufacturing efficiencies, shaving time is always an area of focus. CDMOs must balance time considerations with quality, ensuring safe and effective products are delivered to market. Review by exception is a valuable feature in electronic production records to help manufacturers maintain that balance. When it comes time for quality review before releasing a product, quality managers will have a list of all deviations or quality events that occurred during production and can quickly reference how each was managed. Additionally, quality managers will feel confident that all training was current and standard operating procedures (SOPs) and work instructions were followed. Instead of working through page by page, line by line, quality managers can release product much faster, sometimes in just a few hours, instead of a few days or weeks. Over several product lines with varying batches, this can quickly accumulate into massive time savings.

Conclusion

Digitization in manufacturing is also an important component of Pharma 4.0 initiatives. It is the technology that will connect systems and provide greater transparency, agility, and adaptability to the shop floor. It is through this level of digital and automation maturity that CDMOs will be able to make faster decisions and gain more control over operations, quality, and compliance. Connected systems also provide access to manufacturing data, which unlocks new opportunities for analysis, modeling, and data-based decision-making. This level of business intelligence will propel CDMOs and solidify their role as a critical partner in developing breakthrough therapies.

References:

1. Industry Standard Research (ISR), Outsourced Pharma, and Life Science Leader are all companies nested under the Life Science Connect Umbrella.
2. "How CDMOs are leading innovation for pharmaceutical partners,” Isabelle Heiber, Strategy by EY-Parthenon, July 14, 2022.