Digitization: The Competitive Edge for Leading Life Sciences Contract Manufacturing Organizations

In the dynamic world of life sciences, contract development and manufacturing organizations (CDMOs) have become pivotal in delivering innovative therapies. Recent industry awards have highlighted the excellence of several CDMOs, many of whom are leveraging advanced contract manufacturing software to stay ahead in this competitive field.

MasterControl Customers Recognized as Leading CDMOs

 Earlier this year, Outsourced Pharma Magazine, Life Science Leader Magazine, and Industry Standard Research (ISR) collaborated to celebrate the CDMO Leadership Awards.[i] 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.

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

 To learn more about overcoming challenges in life science contract manufacturing, download our industry brief "Overcoming 3 Key Challenges Facing Life Science Contract Manufacturers."

The Evolving Landscape of Life Sciences Contract Manufacturing

 According to an article from EY-Parthenon, CDMOs have increasingly become leaders of innovation, covering more areas of the pharmaceutical business beyond manufacturing and adding additional revenue streams. They are setting a clear course toward technology leadership and are expected to become even more important over the next decade.

Digitization in Manufacturing: A Game-Changer for Life Sciences Contract Manufacturers

 As the life sciences contract manufacturing sector continues to grow, digitization in manufacturing has emerged as a crucial factor in driving innovation and efficiency. CDMOs that embrace digital solutions are better positioned to overcome challenges related to process management, quality control, and regulatory compliance.

Contract Manufacturing Software: Enhancing Quality Control in Life Sciences

 Quality control is paramount in life sciences contract manufacturing. Advanced contract manufacturing software offers robust features that ensure data integrity, enforce proper procedures, and facilitate real-time error detection and correction. These capabilities significantly contribute to achieving right-first-time production and meeting stringent quality standards.

For example, electronic batch records prohibit operators from moving to a new step before the previous step is completed and alert operators if data is missing during production. Parameters can be set for fields within the record, alerting operators to out-of-spec entries, which can be corrected or managed in real time.

Streamlining Life Sciences Regulatory Compliance With Digital Solutions 

Maintaining compliance in the highly regulated life sciences industry is a constant challenge for CDMOs. Contract manufacturing software plays a vital role in mitigating data integrity issues, managing employee training records, and ensuring adherence to standard operating procedures (SOPs). These digital tools provide a comprehensive audit trail, simplifying both internal and external audits.

MasterControl customers have reported mitigating data integrity errors by 90% or more when using the Manufacturing Excellence software solution. Additionally, the system can alert operators if their training has lapsed and prohibit them from completing tasks until training is updated. 

Want to learn more about addressing key challenges in life science contract manufacturing? Download our industry brief "Overcoming 3 Key Challenges Facing Life Science Contract Manufacturers."

Accelerating Time-to-Market Through Digital Efficiency 

In the fast-paced world of life sciences contract manufacturing, speed is crucial. Digital solutions offer features like review by exception, which allow quality managers to focus on critical issues and expedite product release. This efficiency can translate to significant time savings across multiple product lines and batches.

Quality managers can release products much faster, sometimes in just a few hours instead of days or weeks, by quickly referencing how deviations or quality events were managed during production.

The Future of Life Sciences Contract Manufacturing: Embracing Pharma 4.0

As the industry moves towards Pharma 4.0, digitization in manufacturing will play an increasingly important role. Connected systems and advanced contract manufacturing software will provide greater transparency, agility, and adaptability on the shop floor. This digital maturity will enable CDMOs to make faster, data-driven decisions and maintain tighter control over operations, quality, and compliance.

Conclusion: Digital Transformation as a Competitive Advantage

 The adoption of contract manufacturing software and the broader trend of digitization in manufacturing are becoming key differentiators in the life sciences contract manufacturing sector. CDMOs that leverage these technologies are better equipped to meet the evolving needs of their clients, maintain regulatory compliance, and drive innovation in the development of breakthrough therapies.

 To gain deeper insights into overcoming challenges in life science contract manufacturing, download our industry brief "Overcoming 3 Key Challenges Facing Life Science Contract Manufacturers."

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.