CDMOs 5.0: digitalization for agile and flexible manufacturing
The digital era is booming, and the chemical and pharmaceutical sectors must keep up.
By Nina Mikadze, Manager of Systems and Process Control at AGC Pharma Chemicals Europe, Spain
The need for digital processes and methodologies across the industry is becoming increasingly evident. To maintain the security, integrity and traceability of data generated at all stages of production, speed and flexibility are required in the manufacturing of materials and products.
In addition, sustainable digitalization through tools that make it possible to increase production efficiency while minimizing the impact on the environment are fundamental to a successful, ecological future.
The key to digitalization in CDMOs
Contract Development and Manufacturing Organizations (CDMOs), which develop and manufacture GMP active ingredients and intermediates, need to transform digitally with tools that offer flexibility and agility both in R&D and production plants.
The key to digital transformation is a core business strategy that encompasses the organization, involving the entire product manufacturing process and those necessary to offer a one-stop-shop service.
For this reason, we at AGC Pharma Chemicals are implementing a digital transformation process towards a CDMO 5.0. This includes an interconnected plant for an agile and flexible production ranging from grams in R&D to tons in the production plants, ensuring the highest product quality.
Pioneers in Spain digitalizing the production batch record
Within our digital transformation roadmap, one of the main digitalization projects has been the implementation of Electronic Batch Record (EBR), fully integrated with the Distributed Control System (DCS). We overcame the batch record common digitization by automatically extracting process data and synchronizing it with the manufacturing guide, a real digitalization.
It provides real-time production information, with continuous monitoring and alerts for critical parameters. At the same time, it ensures compliance requirements and data integrity by applying the “review by exception” concept, which involves reviewing only the alerts generated during manufacturing.
AGC Pharma Chemicals is leading the way in digitizing operations in the development and manufacturing of active pharmaceutical ingredients and intermediates. We are achieving more agile, flexible, efficient, and reliable operations, while facilitating regulatory compliance and increasing safety. Ultimately, these improvements result in higher product quality and greater customer satisfaction.