5 Ways Outsourcing can help your Business in 2024

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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.

In the article below, Dr. Jörg Ohl, Sr. BD Director at AGC Biologics, provides insights into the 5 ways outsourcing can benefit your business in 2024 - it is more than just manufacturing capacity!

It is Better for your Business?

CDMOs offer several benefits to large pharmaceutical and small biotech companies. A key advantage is their ability to address the limitation of in-house capacity. Instead of investing significant capital and time into building or expanding your site, a CDMO gives you easy access to manufacturing facilities leveraging the latest technology, with the size of reactors you need to scale your product at any stage.

But there are other ways they can contribute to a healthier business environment during economic uncertainty. For example, a global CDMO, like AGC Biologics, can also ease the burden on your bottom line by giving you access to a vast and dependable supply chain of reliable resources cheaper than what you could purchase for in-house production.

Get Access to Scientific Expertise without Hiring Extra Employees

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 including mammalian perfusion, plasmid DNA (pDNA) production, and cell & gene therapy - this makes CDMOs highly desirable partners.

At our site in Heidelberg Germany, for example, we have been producing biologics for 40 years. That means the expertise in processes, scale-up and manufacturing has been developed, perfected, and passed down over four decades. It has allowed us to build a service offering focused on microbial fermentation strain development through commercial production. This expertise also allowed us to build a plasmid DNA and messenger RNA service line at the site, using the principles of fermentation that have been developed there since it began operating.

Accelerate Your Timeline to the Clinic

Companies also seek partnerships with CDMOs for their ability to execute projects in a timely manner, mitigate risks through secondary sourcing, and improve slower timelines typically associated with large pharmaceutical companies that require more rigorous evaluations and collaborations. So, whether you are a smaller biotech who doesn’t have the resources in-house or a larger pharmaceutical company that requires an outsourcing partner that understands the rigorous processes associated with clinical development – CDMOs can help you speed up your timeline to IND filing.

Implement the Latest Technologies into Your Process Development

CDMOs, are leading the way by using new technologies and methods to improve microbial process development.

For example, at AGC Biologics we have been focused on multi-parallel bioreactor systems like Ambr(R) and DASGIP(R) that 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 and is something that any great outsourcing partner should be using to support your project.

Get Insights from True CMC Experts

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.

Further, CDMOs have scientists with experience in navigating the different regulatory hurdles required at each stage, to ensure CMC guidelines and controls are accounted for and that data is tracked and documented to meet guidelines of top global regulatory agencies.

By adhering to these guidelines and helping developers understand them, good CDMO partners can ensure that the manufacturing processes developed at every phase meet the highest quality standards and regulatory requirements.

Veröffentlicht: 27.03.2024