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Seven critical things to consider before collaborating with a CDMO

Written by EirGenix Staff | Aug 13, 2024 6:17:20 PM

Working with Contract Development and Manufacturing Organizations (CDMOs) can be both rewarding and challenging. Pharmaceutical companies often collaborate with contract manufacturers for many reasons including cost reduction, access to expertise and technology, increased speed and efficiency, scalability and flexibility, and the ability to focus on core competencies rather than spread resources and capital. But there are challenges too that must be considered.

1.   Communication Across Platforms
Sponsors and CDMOs need to communicate across multiple platforms (email, video, phone, and project management tools), and coordinating across these different platforms can be challenging. Plus, there can be multiple people involved in these communications, so keeping track of these conversations can be very tricky. Ensuring seamless information flow and keeping track of these communications are crucial for a successful collaboration.

2.   Balancing Supply and Demand
Managing production capacity and demand fluctuations can be tricky. CDMOs have multiple clients and do not always have on-demand production capabilities due to these other clients. It is critical to ensure that you have adequate supply while avoiding excess inventory. This requires careful planning. We will delve into this topic more below.

3.   Quality Control and Compliance:
Different countries and regions have different regulatory and quality standards. It is a challenge to meet these high-quality standards and comply with regulatory requirements. Any deviations can impact product release and delay clinical trials or commercial supply. It is important to understand your CDMO’s current and future ability to meet these requirements and be immediately notified when an issue arises. You should also always consider contingency plans.

4.   Technology Transfer and Scale-Up
Transitioning from lab-scale to commercial-scale production, transferring from an internal resource to an external resource, or transferring between CDMOs involves a technology transfer. Ensuring consistency and efficiency during scale-up can be demanding. See our other article on technology transfer.

5.   Supply Chain Disruptions
As we learned during the COVID-19 global event, CDMOs rely on a complex supply chain for raw materials, equipment, and logistics. Disruptions due to these global events can impact production timelines and material availability. Planning in advance for contingencies is critical and just a smart business practice.

6.   Access to Data
Sponsors rely on timely access to data such as batch records and analytical results. Therefore, it is important to be mindful of data delays and data visibility issues. Delays in access to data can hinder critical decisions and slow project progress. Timely access to data is essential.

7.   Import and Export Rules
The rules regarding international regulations and trade restrictions can be complex and tricky. They dramatically affect the movement of materials and finished products to and from the sponsor and the CDMOs. It is important to understand these rules so both parties can navigate their complexities.

As mentioned above, balancing supply and demand is a critical task. Let’s take a closer look at the key pieces involved in this.

1.   Assess Your Material Needs:
    • This information helps the CDMO scope the project accurately.
    • Understand the scale needed (e.g., fermenter or bioreactor size) and downstream process equipment requirements (e.g., chromatography column volume).
    • Determine the quantity of material required for your project, considering clinical trial patients, dosing regimen, and overall yield.
2.  Define Your Timeline
    • Communicate your target dates for project initiation and final product delivery. Set upfront if these are absolute or if there is some date flexibility.
    • Be aware of critical factors affecting the timeline, such as batch record approval, raw material specifications, and QA release.
3.  Evaluate Process Development Capabilities
    • Unexpected issues can and do arise during scale-up. It is important to ensure the CDMO has a process development group to manage these issues and the communication flow to resolve these issues.
    • Understand and verify the CDMO's expertise in technology transfer and process optimization.
4.   Analyze Analytical Methods
    • Do you know the extent to which your CDMO can perform various analytical testing? Do you know what is done in-house versus what they outsource? It is important to understand and confirm that the CDMO can apply necessary analytical methods for in-process testing and final product evaluation. If not, the Sponsor needs to be prepared to step in and manage it quickly.
    • Make sure to evaluate the CDMO’s ability to meet pharmacokinetics, toxicology testing, and clinical trial needs.
5.   Consider Regulatory Aspects
    • As stated above, there are many regulatory authorities each with their own unique set of rules and regulations. It is important to define which territories you will need to comply with and see if your CDMO meets those standards.

Summary

In summary, addressing these challenges through effective communication, risk mitigation, and strategic planning will enhance your collaboration with CDMOs. By addressing these steps, you’ll be better prepared to choose the right CDMO for your biologic project.

Are you seeking a contract biologic development and manufacturing (CDMO) partner that takes a comprehensive approach to partnering with its clients? EirGenix considers issues such as analytical breadth, quality, supply chain concerns, compliance with multiple regulatory agencies, and has a well-thought-out technology transfer plan! At EirGenix, we take the right approach and offer top-notch customer service at a better value. Since 2012, EirGenix has offered mammalian and microbial biopharma development and production including cell line establishment, process development, analytical development, clinical and commercial scale production, and cGMP quality system operations that are certified by the US FDA, Japan PMDA, Australian TGA, Taiwan FDA, and Europe EMA. We would appreciate the opportunity to collaborate with you!

 

References:

What’s Next for CDMOs After COVID-19? - https://www.bcg.com/publications/2021/the-four-critical-steps-for-cdmos-post-covid-19

10 Ways to Improve Your CDMO Partnership - https://www.apprentice.io/resources/10-ways-to-improve-your-cdmo-partnership

Part 2: What You Should Expect from A High-Functioning CDMO - https://www.cellandgene.com/doc/part-what-you-should-expect-from-a-high-functioning-cdmo-0001



Consider working with EirGenix!

At EirGenix, client success is our priority!  Since 2012, EirGenix has offered mammalian and microbial biopharma development and production including cell line establishment, large-scale production process development, analytical method development, and cGMP quality system operations that are certified by the US FDA, Japan PMDA, Australian TGA, Taiwan FDA, and Europe EMA. Our values include Empathy, Integrity, Responsibility, and a global vision.  We hope you will work with us!

 

You can virtually tour our site here. We would appreciate the opportunity to collaborate with you! Click on this link to contact our BD team.