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Tips to Build the Best Strategy for Microbial Fermentation Outsourcing in 2024

Tips to Build the Best Strategy for Microbial Fermentation Outsourcing in 2024

Insights from our Microbial Subject Matter Expert, Dr. Jörg Ohl!

The role of Contract Development and Manufacturing Organizations (CDMOs) in microbial manufacturing processes is undergoing significant change. With years of experience in production and in-house scientific expertise, CDMOs have seen an increased use of standard microbial hosts such as E. coli and P. pastoris, and have developed extensive knowledge of various production host systems. 

CDMOs are embracing the latest trends and advancements in microbial manufacturing, marking a significant shift in industry dynamics. A well-trained and educated team ensures seamless interaction with developers, enhancing communication and understanding of client requirements. The ability to manufacture using state-of-the-art technology, combined with a dependable supply chain, guarantees on-time delivery to the developer’s production pipelines. Lowering development and production costs, while also increasing process robustness, has become increasingly important in the pharmaceutical industry. 

In the article below, I am giving tips on the evolving role of CDMOs in the industry and the benefits we can offer here at AGC Biologics. I will highlight changes in the industry, including the increased use of standard microbial hosts, the adoption of advanced technology, and the importance of efficient processes and regulatory compliance.  

The Impact on your Business is the Bottom Line: 

CDMOs offer several benefits to pharmaceutical and biotech companies. One of the main advantages is their ability to address the limitation of in-house capacity, which often necessitates seeking external partnerships. Another reason companies choose to partner with CDMOs is the challenge they face when recruiting new talent within tight timelines, which further underscores the need for these collaborations.  

AGC Biologics brings valuable expertise and knowledge that is not readily available in-house, particularly for originators embarking on their first microbial project. We are leaders in cost reduction and project management, with experience in specialized fields includes mammalian perfusion, pDNA production, and cell & gene therapy makes them highly desirable partners. 

Companies also seek CDMOs for their ability to execute projects in a timely manner, mitigate risks through second sourcing, and navigate the slower timelines typically associated with large pharmaceutical companies. These factors contribute to the growing demand for CDMOs in the industry. 

CDMOs are Experts in Process Development: 

CDMOs, like AGC Biologics, are leading the way by using new technologies and methods to improve microbial process development. Multi-parallel bioreactor systems like Ambr(R) and DASGIP(R) provide fast, reliable, and qualitative read-outs for process development. These small-scale parallel bioreactors offer a plethora of process information, facilitating efficient culture comparison and the simultaneous execution of multiple experiments. Additionally, the use of Design of Experiments (DoE) further enhances the precision and efficiency of microbial process development. 

CDMOs are CMC Experts: 

In order to maintain a competitive edge in microbial manufacturing and ensure regulatory compliance, AGC Biologics employs proactive strategies. These strategies encompass various crucial aspects, one of which is staying up-to-date with current Good Manufacturing Practice (cGMP) production guidelines. By adhering to these guidelines, CDMOs can ensure that their manufacturing processes meet the highest quality standards and regulatory requirements.