Noah Machakos
Table of Contents
How to Choose the Right CDMO Partner for Protein Production
Introduction
Choosing your CDMO partner for protein production is one of the most important decisions a biopharmaceutical company will make. Whether you’re developing a new therapeutic protein, monoclonal antibody, or vaccine candidate, selecting the right CDMO services can accelerate timelines, ensure regulatory compliance, and reduce manufacturing costs.
At Molecular Pharming Solution, we offer plant-based protein production CDMO services using Nicotiana benthamiana, supported by our GMP biologics manufacturing in Asia at our cGMP-certified facility in Bangkok. As a full-service contract manufacturing partner, we assist clients with research and development, including GMP protein production. In this guide, we share the key criteria for choosing the right protein production partner and explain why Molecular Pharming Solution is uniquely positioned to support your project.
What to look for in a CDMO?
There are many different companies who might choose to work with a CDMO. Oftentimes, if you’re an early-stage biotech startup, you are entirely focused on R&D and don’t have any in-house manufacturing capabilities. You are looking for help with process development and scale-up and of course producing the actual product.
A more mid-sized biopharma company would look to a CDMO to help support the development of a new product or to help them with specialized formulations. They might find themselves at a crossroads of sorts – they have grown beyond early-stage R&D but still lack the full resources and infrastructure of a large pharmaceutical firm. By partnering with a CDMO, they can avoid the need to invest immediately in a costly cGMP facility, allowing them to conserve capital and allocate resources to other areas (Moreira & Klueter, 2022). Perhaps a mid-sized biopharma company has their hands in multiple fires, so to speak, with a few different programs running simultaneously. Working with an external CDMO would ensure they don’t compromise quality.
The following are some factors to consider as you choose the right partner for your needs.
1) Technical Expertise in Protein Production
When it comes down to it, technical expertise in the process is the single most critical factor. The field of biologics is highly technical; protein production requires specialized knowledge in expression systems which includes careful control in multiple biologics systems occurring all at once, and careful adherence to regulatory processes. If your product is going to succeed, it will lean heavily on the CDMO’s know-how and process efficiency. You will want to evaluate their experience with the specific type of protein you are producing whether it be antibodies, vaccines, cytokines, or others (Pasdar et al., 2024).
The CDMO will need to be effective in both the upstream formulation preparation for preparing the genetic vectors, as well as the downstream protein extraction, followed by good analytical testing to ensure the quality you expect. Spending your time doing good due diligence to see whether your potential partner can perform all these is crucial. If your potential CDMO has published research proving their success, that is all the better.
2) End-to-End CDMO Services
Your CDMO services partner should be able to support the full development lifecycle. This will make them an easy one-stop shop capable of meeting your demands the whole way through the process. If your partner is working with you throughout the whole development of your process, this will ensure much more consistent end-result quality as well as a faster timeline for you. In your selection process, you should look for a company that has adequate staff for each step of the process. It will also be hugely beneficial for you if your partner has a clear understanding of the regulatory frameworks for getting your product approved.
Why Molecular Pharming Solution: Our CDMO services will take care of you throughout the entire value chain. Molecular Pharming Solution can work with you to provide initial construct design as well as GMP protein production. Our tested platform ensures seamless integration throughout all stages of biopharmaceutical development. Our fully-fledged cGMP facility in Bangkok also enables clinical and commercial production which meets strict international standards.
3) Regulatory Compliance and Global Standards
The world of developing biopharmaceutical products is highly regulated, to say the least. For a product to reach its target market successfully, it needs to demonstrate strict adherence to Good Manufacturing Practices (GMP) the whole way through the upstream and downstream manufacturing process.
Whether the therapeutic protein you are designing is for the European, Asian, or U.S. market will also lead to different standards and expectations to be met. For your protein production partner to be a true global partner, it needs to maintain documentation and traceability systems that far exceed the standards set all over the world, to make sure that your project is always inspection ready. There needs to be clear batch record retention and robust procedures surrounding data integrity. There needs to be good quality assurance using the latest technology, as well.
Your protein production partner should adhere to Good Manufacturing Practices (GMP) and have a complete understanding of the regulatory landscape of target markets depending on the type of biologics being made. The CDMO needs to have familiarity with FDA, EMA, and regional guidelines.
For us at Molecular Pharming Solution, we maintain stringent standards over the quality of our plant-based protein production CDMO systems. We have demonstrated strong leadership in this space throughout the past years and will continue to do so.
4) Speed and Cost-Efficiency
As you’re considering a CDMO to work with, you need to pay strong attention to their potential to deliver speed-to-market as well as keeping costs under control. Every day matters as you are developing your novel therapeutic or biologic product. If there are delays, this can cause missed opportunities and also investor concerns. Your CDMO partner shouldn’t just be a vendor for you, they should essentially be an extension of your team that works in a responsive manner and operates with foresight.
Speed and costs are critical aspects in the global biopharmaceutical development scene. Your CDMO services provider should be able to work in a highly efficient manner for you as well as being highly agile in working to meet your needs.
What to Look For:
- Quick turnaround times throughout all steps of the process – This begins back in vector design and continues through protein purification and GMP batch release.
- Scalable manufacturing solutions – even if you are just producing a few milligrams for preclinical studies or are looking to scale kilogram-level commercial batches, the CDMO should be able to scale at all stages of the process.
- Transparent pricing and low operational costs to avoid cost creep – You want to know going into the process that your CDMO will be able to achieve the milestones that you are expecting them to hit. Make sure you maintain financial control by looking out for hidden fees and avoid cascading operational costs.
Why Plant-Based CDMO Services Are the Future
Molecular Pharming Solution is ready to meet all your CDMO needs through our plant-based expression systems, via Nicotiana benthamiana. Plant-based CDMOs leverage plants to produce proteins, antibodies, vaccines, and other biologics. They offer several advantages as a CDMO over traditional expression platforms:
- Rapid scalability – since we are doing transient expression in N. benthamiana, our platform allows for rapid scale up, moving from the gene sequence to complete, purified protein quickly. We are able to make the adjustments that you need for your project.
- Absence of human pathogens – since we are a non-animal system, our system inherently reduces the risks of contamination by human or mammalian pathogens. This is important in terms of downstream purification of vaccines or therapeutic proteins.
- Lower production costs – N. benthamiana-based infrastructure is significantly less capital-intensive than other traditional systems. Our Bangkok-based operations further lower production costs because of favorable labor costs and streamlined supply chains in the region.
- Environmentally sustainable processes – Our plant-based platform is also very environmentally sustainable and generates less waste than other systems. If your company is prioritizing ESG goals and green biomanufacturing, then Molecular Pharming Solution could be a great partner for you.
Strategic Location in Bangkok, Serving Global Clients
Working with a CDMO partner in Southeast Asia can offer regulatory, logistical, and cost advantages over other locations. We see Thailand emerging as a regional hub for biotech innovation because of the access to Asia-Pacific clinical trial networks.
Molecular Pharming Solution’s Bangkok facility allows our clients to benefit from GMP biologics manufacturing in Asia with a quality that is fully up to international standards and offering international-quality services at a small chunk of U.S. or European CDMO services costs.
Conclusion: Choosing the CDMO partner that is right for you
We hope that this article provides more information for you to figure out what the right CDMO partner for protein production is for your company. CDMO selection is more than simple outsourcing—it’s centered on several principles as outlined above that build a trusted collaboration to accelerate your molecule’s path to market (Hotha, 2023). At Molecular Pharming Solution, we combine scientific excellence in manufacturing, regulatory expertise in documentation, and operational efficiency all along the way to help you succeed.
References
Moreira, S., & Klueter, T. M. (2022). Contract Development & Manufacturing Organizations and out-licensing decisions. Academy of Management Proceedings, 2022(1). https://doi.org/10.5465/AMBPP.2022.61. Academy of Management JournalsFox School of Business
Pasdar, M. A., Sivilotti, M. M., Jaehn, P. S., Baghbaderani, B. A., Lee, J., Levine, B. L., & Milligan, W. D. (2024). Contract development and manufacturing organization selection: Critical considerations that can make or break your cell and gene therapy development. Cytotherapy, 26(7), 656–659. https://doi.org/10.1016/j.jcyt.2024.03.002. PubMed
Hotha, K. K. (2023). Unleashing the power of innovation in CDMOs through customer-centricity and culture of service. American Journal of Industrial and Business Management, 13(4), 234–246. https://doi.org/10.4236/ajibm.2023.134016. scirp.org