CDMOs (contract and development manufacturing organizations) are a significant resource for biotech and pharmaceutical product development.

A crucial aspect for the success of CDMOs, LIMS (lab information management systems) enables their transition to Industry 4.0 during the R&D phase and synergies that facilitate manufacturing.

CDMOs are gaining traction along with the growth of outsourcing. This approach has aided the development and profitability of many life sciences organizations. Experts estimate CDMO 2022 revenues attained $159 billion, projecting an 8% CAGR (compound annual growth rate) through 2030.

The surge of CDMOs was driven by their role in making it possible to swiftly manufacture great quantities of COVID-19 therapeutics and vaccines in an unprecedented manner. In addition, R&D and manufacturing of other pharmaceutical products also expanded. As a result, publicly traded CDMOs reported profits ranging from 10% to 20% at the end of June 2021. Unfortunately, economic data for 2022 is not as promising as economists predict a recession. Thus, CDMOs must be highly efficient to remain profitable by supporting data-driven research, which is an aspect of Industry 4.0.

Importance of Data-Driven R&D

Digital informatics allows organizations to have deeper insights, greater knowledge of operations, and improved control. Real-time reports include certificates of analysis, condition evaluation, regular analysis, and trends. Thus, companies have the information required to improve operations and the quality of products. Moreover, greater data access enables research that leads to novel perspectives.

Theoretically, data kept within a LIMS should not be stored in inaccessible silos or limited to only one database. In contrast, LIMS data, which includes experiment results, inventories, issues, and reports, should be immediately accessible system-wide.

Product development can move forward quickly if concerned parties are working from a single source of information. Thus, reports can be generated from the master data stored by a LIMS. This results in speeding the transfer of knowledge and hastens the process of therapeutic development.

Part 2 will discuss Digitization Benefits, Instrument Integration, Improved Efficiency, and Greater Accuracy.

Alpha Engineering LIMS Implementation

Alpha Engineering Associates, Inc. has been involved with the implementation of over 50 LIMS systems ranging in size from small, “off-the-shelf” software systems to very large, highly customized, multi-functional systems, including STARLIMS, for both governmental agencies and private enterprises. For affordable client-focused network consulting services and solutions, please call Alpha Engineering Associates today at (410) 295-9500.