How has business been for CMC Pharmaceuticals of late?

We have had a productive year, particularly with our continued collaboration with the Department of Defense on Nerve Agent Defense programs. 

How does CMC demonstrate its expertise in executing projects?

We bring extensive chemistry and manufacturing expertise to many programs. Our team consists of chemists and chemical engineers with years of experience in pharmaceutical development, from early-stage formulation to stabilizing strategies and scale-up. We often start by producing small batches in the lab, then scale to larger quantities, and ultimately help clients transition to full-scale commercial manufacturing. 

Can you share an example of a project that highlights CMC’s capabilities?

A great example is a recent project where we extended the shelf life of prophylactic medicine for the military. Initially, the product had only a 30-day shelf life, leading to significant waste. The Department of Defense came to us for help in generating stability data to support an FDA filing for an extension. We conducted a multi-year stability study, developed the necessary analytical methods, and successfully extended the product’s shelf life to over a year. This project not only highlights our technical expertise but also our ability to collaborate effectively with government agencies.

What industry trends are shaping pharmaceutical development, and how is CMC adapting?

One key trend we are seeing is the increasing focus on creating a comprehensive CMC package from the start. This means ensuring that formulation, stability work, and analytical methods are all aligned to support scalability and regulatory compliance. Many companies faced delays due to inadequate early-stage chemistry and manufacturing efforts, so we emphasize a science-driven approach. We balance the need for speed in drug development with strict regulatory requirements by focusing on robust data, sound justifications and a well-structured technical package.

How does CMC support a sustainable business model?

We aim to deliver strong science and top-tier customer service, which helps us build trust and secure repeat business. A prime example of this is our ongoing work with the Department of Defense. We see sustainability as part of our long-term strategy to continue providing value to our customers while maintaining our environmental and operational standards.

How has AI influenced the industry’s drug development processes?

AI has influenced the early stages of drug discovery, particularly in identifying excipients and stabilizing formulations. While we do not develop AI-driven models ourselves, some of our clients are leveraging AI for drug discovery. Once they have identified promising candidates, we come in to help with formulation and development, ensuring the stability, absorption, and solubility of the products. While AI helps speed up the initial discovery, the real work takes place in the lab, where we validate and refine these formulations for real-world applications.

What sets CMC apart from competitors?

Our deep expertise in drug chemistry, combined with our agility as a smaller company, allows us to respond quickly and effectively. We can initiate contracts and move to lab work faster than many mid-sized firms. Our team’s decades of experience and specialized expertise in chemistry and manufacturing are key differentiators. Our focus on customer service—consistent communication, transparency, and project management—ensures that development stays on track, making us a trusted partner to our clients.

How do you see CMC evolving over the next decade?

We are focused on significantly expanding our capabilities. We have been executing a growth plan that aims to double our size in terms of people, services, and facilities within the next four years. We will continue building on our core areas—formulation, analytical stability, process development, and scale-up—and further enhance our new service offering, contract manufacturing oversight. Our ability to help clients find and oversee commercial manufacturing sites has become an integral part of our strategy.

What will CMC focus on in 2025?

In 2025, we will be focused on continuing to ramp up our expanded services. We are investing in new lab equipment, building out more lab space, and strengthening our quality unit to support manufacturing oversight. We will also be adding more chemists to our team to meet the growing demand.