Interview with:

• James. J. Chen, Ph.D., CEO & Founder
• Shamim Ahmed, Ph.D., EVP, Pharmaceutical Development
• Bin Li, Ph.D., EVP, Chemistry R&D
• Robert W. Lee, Ph.D., SVP, Business Development
• Sheldon Huang, EVP & General Manager, Manufacturing

Who is Agno Pharmaceuticals?

Agno Pharmaceuticals has been a trusted name in the pharmaceutical and drug development industry for over twenty years. Our seasoned CDMO team is dedicated to developing high-quality, innovative solutions for our clients so they can produce and deliver pharmaceutical products that make a difference. This article features insights from senior team members, introducing who Agno Pharmaceuticals is, what we stand for, and how our commitment to pharmaceutical innovation is shaping the future of healthcare.

James Chen, Ph.D: Agno Pharma is a premier global end-to-end pharmaceutical CDMO that provides solutions to clients’ complex chemistry, complex formulation, and complex manufacturing outsourcing needs. 

Bin Li, Ph.D: Agno is a CDMO company. Our goal is to balance quality, cost, and speed to help our clients move their drugs to the market faster and cheaper while prioritizing quality at every stage—from development through to market.

Sheldon Huang, EVP: Agno is a very special CDMO company. We have experts to facilitate every stage of development: chemical physicists, business development specialists, seasoned pharmaceutical development professionals, plus more. Our state-of-the-art technology allows us to deliver superior products, solutions, and experiences to our clients.

Shamim Ahmed, Ph.D: Agno Pharmaceuticals is a one-stop shop. From RSM to intermediates to API and finished product manufacturing, we cover all aspects of pharmaceuticals from A to Z.

The History of Agno Pharmaceuticals

James Chen, Ph.D: Agno Pharma is a US-based CDMO, registered in the state of Delaware in January 2004. The initial business focus was on analytical CRO and regulatory consultation services. The business focus was changed to API and intermediate development and cGMP manufacturing in 2010. In 2020, Agno Pharma started its drug product formulation development services. In 2023, it expanded its formulation development services to include drug implant development and drug product and implant cGMP manufacturing via the acquisition of Particle Sciences. To further develop Agno Pharma as a “premier global end-to-end CDMO,” an investment deal with Vivo Capital and Bain Capital was closed in February 2024. This investment enables us to provide clients with the best CDMO services available, including innovating new technology and approaches to further enhance their projects and drug development experiences.

Shamim Ahmed, Ph.D: Agno was an intermediate RSM and API company ten years ago. At that time, I was at Pfizer and asked James if he could make a sterile API for a project. James is a person who never says no. He just figures out how to do it, and that’s what he did for my project. We then asked if he could put the API in a vial instead of in a canister. Again, he said yes. That kind of determination is foundational to Agno Pharmaceuticals and has been the common thread as the company has grown and evolved. Our team has an ingrained culture of innovation and exploration, testing and creating solutions until we can find something to meet client needs. Companies approach us and ask us to solve their problems, and that’s what we do.

What Sets Agno Pharmaceuticals Apart?

Agno’s five core competencies differentiate us in this market:

• Exceptional services and products
• A dedicated team of US pharma-experienced talents
• Technical expertise in complex product development and manufacturing
• FDA-proven regulatory compliance systems
• Responsible EH&S systems

All company executives are US pharma veterans, which means our company culture and values align well with those of our Western clients. Here’s what our team had to say about what sets Agno apart:

Bin Li, Ph.D: Agno Pharmaceuticals has an excellent track record of providing services to our clients.  When clients are happy, our business grows, and we’re seeing the fruit of that. We boast an incredible success rate. Over the years, we’ve executed roughly 400 projects. Only 3 of those projects weren’t completed on time but were delivered with slight delays. Less than 1 percent of our client projects weren’t delivered according to our initial timeline. No other CDMO can claim that level of success.

Robert Lee, Ph.D Agno is one of the best CDMOs when it comes to nanomilling and particle size reduction. We’re going to be onboarding aseptic nanomilling on both commercial and clinical capabilities. I’m not aware of any other CDMO that offers aseptic nanomilling at this point.

On the finished product side, we have a lot of flexibility. We have a DEA license for all schedules, including Schedule 1, allowing us to handle highly potent compounds depending on the exact API, form factor, etc. Our colleagues in China have outstanding capabilities for highly potent compounds, working on beta-lactams, oncology agents, and things that are a bit unusual for the API side.

Shamim Ahmed, Ph.D: Agno’s biggest asset is our flexibility. We’re very much a customer-centric company. As a product transitions from API to a finished product, each stage needs a dedicated line and facility. Agno is always willing to provide a product-specific line or building. We never say no. And quality is always guaranteed.

Another differentiator is our end-to-end capability. There are very few CDMOs in the world who can do sterile micronization, and we have that capability in China. What makes us different is we can make a sterile micronization and add it to a finished product. It’s a one-step process for the client that very few, if any, other CDMOs can provide.

Sheldon Huang, EVP: We passed our FDA on-site inspection in June 2024. At the beginning of this year, we also passed China’s FDA on-site inspection, which means our quality is top of the line. Our China facilities empower lower costs and faster timelines without sacrificing quality. Customers know they can trust us with their projects from start to finish.

Capabilities and Areas of Expertise

At Agno Pharmaceuticals, we solve problems. Our clients come to us with specific needs and requests. Thanks to our end-to-end capabilities, we can address client needs head-on with the right approach at the right time to deliver exceptional results. Over the years, if we haven’t had a solution to client needs, we’ve invented new technology to develop novel solutions. Agno Pharmaceutical’s culture is one of exploring, innovating, and thinking outside the box, and that shines through in our various capabilities and areas of expertise:

Complex Chemistry

• Flow Chemistry
• Enzymatic Chemistry
• Cryogenic Reactions
• Asymmetric Epoxidation
• Oxygen & Moisture-free Reaction
• Chromatography
• High-potent API

Complex Formulation

• Nano-milling
• Micro-milling
• Cryo-milling
• Hot Melt Extrusion
• Injection Molding
• Spray Drying
• High-Pressure Homogenization
• Lyophilization

Complex Manufacturing

• API & Intermediates
  • Continuous Production
  • Chromatography
  • High Containment
  • Aseptic Processing

• Drug Product
  • Nano/Micro Suspension PFS
  • Microsphere PFS/Vial
  • Nano Emulsion PFS/Vial
  • Sterile Powder-Fill
  • Drug Implants
  • Depot

Agno Pharma offers a comprehensive suite of integrated analytical services that bridge development and analytical expertise, tailored to support the entire pharmaceutical lifecycle, from research and development to commercial manufacturing. We have multiple sterile manufacturing lines for both highly potent and regular APIs. Whatever our clients need, we either implement the technology and resources at our disposal, or we innovate new solutions to ensure their project is successful.

Looking Ahead: The Future of Agno Pharmaceuticals

Agno has a rich history of meeting –– and anticipating –– client needs for successful drug development projects, and the horizon is bright for both our customers and our teams. Our leadership team shares what’s ahead for Agno Pharmaceuticals:

James Chen, Ph.D: Our vision is to fully develop Agno Pharma as a premier global end-to-end CDMO. Our near-term mission is to establish our API development and clinical manufacturing capabilities in the U.S. and strengthen our commercial drug product manufacturing capabilities in the U.S., Europe, and Asia. Furthermore, Agno Pharma is in the process of evaluating adding API commercial manufacturing capabilities in Europe and Asia.

Shamim Ahmed, Ph.D: Commercial manufacturing capability is limited in the U.S. We’re expanding in China, but we also want to expand here in the U.S. We’re actively looking for growth opportunities via acquisition or buying land and/or existing facilities. In the U.S., we want to focus on low-volume, high-value products in niche markets, and we want to make sure we have commercial manufacturing capabilities for these products. The goal of our expansion is to give our clients the option for manufacturing in the U.S. or China, establishing ourselves as a truly global company. As James said earlier, our recent acquisition is backed by two big investors, which has allowed us to enter this new mode of expansion.

Robert Lee, Ph.D: Agno is willing to grow with our clients and invest with them, making ourselves attractive from a financial and cash flow perspective, helping get clients into registration batches and commercial. This approach adds a ton of value to potential clients and positions us to help them enter the marketplace, giving us the opportunity to grow the commercial and finished product side.

Additionally, we can now make sterile APIs that enable aseptic nanomilling on virtually any crystal API with a high melting point that’s amenable to that technology. We can have our colleagues in China manufacture sterile APIs with fully aseptic processing to enable some of these unique dosage forms. The fact that we’re able to do larger-scale commercial finished dosage forms in China with respect to aseptic nanomilling and, at some point, PLGA microspheres opens up a different universe as far as complex products that add value to the patient from patient compliance / patient-centric perspectives.

In Conclusion: Why Agno?

Agno is an extension of any pharmaceutical company’s development and manufacturing site. We never think, “This is a customer project,” but “This is our project.” We take ownership of the product, working with the customer in development and manufacturing, setting us apart from every other CDMO. Our entire team is dedicated to our clients’ successes. With our resources, state-of-the-art technology, infrastructure, and seasoned expertise, Agno delivers tailored services across the drug development spectrum, ensuring superior quality and compliance from preclinical to commercialization.