The Benefits of Partnering with a US-Based CDMO: Quality, Efficiency, and Peace of Mind

In the fast-paced world of biopharmaceuticals, choosing the right contract development and manufacturing organization (CDMO) is crucial to the success of your drug development program. At Vernal Biosciences, we pride ourselves on being a US-based CDMO that produces all products domestically.  

Here are key benefits of partnering with a CDMO like Vernal Biosciences: 

1. Legal and Ethical Standards
Countries like the United States, with strong legal and ethical frameworks experience lower rates of breach of contract and misuse of intellectual property. While seldom needed, our statutes, rule of law, and access to relief incentivizes parties to play by the rules. This enables transparency and collaboration, the crucible of successful projects. 

2. Regulatory Oversight
The US offers stringent regulatory oversight by the Food and Drug Administration (FDA), which enforces GMP standards.  In addition to regulation adherence, the FDA, CDMOs, and sponsors work together to come up with solutions that are always in the best interest of the patients we seek to serve. 

3. Market Access
Adhering to the expectations of the FDA means that you have one less hurdle to deal with in accessing US markets for your transformative medicines. 

4. Enhanced Communication and Collaboration
Proximity matters when it comes to communication and collaboration.  Our location makes it easier for North American customers to place people in our plant to audit and observe operations. Working with a domestic CDMO facilitates real-time communication and quick decision-making. This can be a significant advantage when addressing urgent issues or making timely adjustments to your development plans. 

5. Transparency and Traceability
US statutes and regulations for GMP and clinical trials require detailed documentation, record-keeping, and data security, which enhances transparency and traceability in the manufacturing process. This ensures that every step of production can be tracked, audited, and verified, making it easier to identify and address any issues.

6. Supply Chain Integrity
Manufacturing domestically can simplify and secure your supply chain. Shorter and more localized supply chains reduce the risk of contamination, counterfeiting, and other issues that can arise from complex international logistics. Additionally, by working with a US-based CDMO that produces all products domestically, you mitigate risks associated with geopolitical tensions, trade restrictions, and global shipping disruptions.

7. Quality Control
Due to the stringent standards of the FDA, when you work with a US-based CDMO you benefit from stringent quality control standards. US manufacturers often invest more in advanced quality control technologies and practices, ensuring higher standards of product quality and consistency. By producing all products in the US, we adhere to these high standards, giving you confidence in the quality of your drug substances and drug products. 

8. Supporting Domestic Innovation and Economy
Choosing a US-based CDMO also means supporting domestic innovation and contributing to the local economy. By investing in local expertise and infrastructure, you help drive advancements in biotechnology and pharmaceutical manufacturing within the country. 

Your Ideal Partner

At Vernal, we bring a wealth experience in developing mRNA medicines to help you navigate the complexities of manufacturing. We are happy to share the good fortune of Vernal’s location with our customers to achieve a non-negotiable level of accountability. That, along with our end-to-end platformed manufacturing and analytical technologies, is how we reduce risk and get your mRNA medicines to patients faster. Let’s have a conversation about how to make your program successful.

Contact us today!