An Interview With:

• Bin Li, Ph.D., EVP, Chemistry R&D
• Sheldon Huang, EVP & General Manager, Manufacturing
• Shamim Ahmed, Ph.D., EVP, Pharmaceutical Development
• Robert W. Lee, Ph.D., SVP, Business Development
• Brian Treco, Ph.D., VP, Business Development

Regulatory Starting Materials (RSMs) and intermediates are pivotal to pharmaceutical success due to their multifaceted impact on development, regulation, and commercialization. Quality Control & Product Consistency, Regulatory Compliance & Submissions, Cost Efficiency & Scalability, Environmental & Safety Compliance and Supply Chain resilience are essential. At Agno Pharmaceuticals, we have the expertise, experience, equipment, and sourcing capabilities to ensure RSM and intermediates excellence and position your project for success.

Why Regulatory Starting Materials and Intermediates are Critical to Pharmaceutical Success

Brian Treco, Ph.D: RSMs and intermediates are essential to your drug development program. You have to have good, reliable, high-quality sources to create good, reliable, high-quality final products, and it’s most efficient and best practice to build in that quality at the very beginning of your development. Purifying afterward is an option, but it’s time-consuming, expensive, doesn’t always work, and is often unacceptable from a regulatory standpoint. When sourcing RSMs and intermediates and bringing them through development, you want a company you can count on. Pharmaceutical companies need CDMOs that can make these RSMs and intermediates in a reproducible, high-quality manner, driving quality from the supply chain to the API and beyond.

Most of the time, the RSM is unknown when our team is approached for a project. We and our clients have to consider all possible eventualities. What they think the RSM is may differ from the FDA, and the FDA’s opinion will trump client opinions, significantly affecting how development proceeds. That’s why it’s essential to have a company that can accommodate all potential changes in the regulatory systems. Agno has the flexibility to supply whatever the client needs under GMP to ensure agility as FDA, EMA, and other regulatory bodies impose various requirements and standards.

Robert W. Lee, Ph.D: Garbage in, garbage out. If you start with something less pure, you’ll carry impurities throughout development and might have detrimental secondary reactions. It’s essential to start with quality products to maintain quality from beginning to end.

How Agno Helps Pharma Companies Navigate Regulatory Hurdles

Maintaining regulatory compliance is non-negotiable. Every drug development project needs a CDMO with knowledge and the ability to think ahead to ensure you’re meeting regulatory requirements at every step of your project. Below, our team highlights how Agno helps our clients navigate the many regulatory hurdles of drug development.

Bin Li, Ph.D: The team at Agno has decades of experience with various regulatory agencies and a deep understanding of their guidelines and regulations. Our knowledge of agency expectations allows us to help pharmaceutical companies, especially for small biotech companies, choose the right RSM while meeting requirements and balancing time and cost so the product can go through to commercial with as few hiccups as possible.

Sheldon Huang, EVP: Regardless of what material we are making, we strictly follow GMP guidelines and regulations in all our facilities. We have our CGMP quality systems in-house, so we can help clients understand what they want and what they need to meet—and even surpass—regulatory requirements for a streamlined drug development project.

Brian Treco, Ph.D: Significant bottlenecks can occur when the FDA doesn’t approve your RSM. At Agno, RSM is manufactured under GMP-light condition: all raw materials have been properly released and all the operations are recorded according to the MBR. If the FDA wants the pharmaceutical company to move 1 or 2 steps back as the RSM, we just need to validate the analytical methods to qualify these steps under cGMP.

Another potential hurdle is, of course, the supply chain. Other places in different parts of the world get their raw materials almost exclusively from China, adding weeks to lead time. Because we’re located in the Shanghai region, and because of its massive manufacturing capacity, we have immediate access to these materials. We can source RSMs quickly to begin projects in a matter of days, not weeks.

Robert W. Lee, Ph.D: We do a lot of work with highly potent compounds and beta-lactams. From a regulatory perspective, you need a dedicated facility to produce these. Agno has dedicated buildings for beta-lactams, allowing us to safely synthesize and handle these materials. Very few competing manufacturers have comparable infrastructure. Agno takes safety extremely seriously; we have the engineering, controls, infrastructure, protocols, and controls to keep our folks safe while ensuring product quality and efficacy.

Brian Treco, Ph.D: Manufacturers have to not only have these capabilities we’ve already mentioned but also work ahead of the curve. What were the highest capabilities a few years ago are now the lowest bar because of shifting client demands and expectations. What was considered standard before won’t be the standard ten years from now.

Here at Agno, we’ve been moving further into higher containment levels, working to get these containment levels higher and tighter to handle more highly potent compounds than ever. We know clients will ask this of us, so we’re ready for it. We’re making the investments, training the people, and ensuring 100 percent safety for our employees. Requirements and expectations will only get tighter and stricter; we’re ready for that. In this market, meeting the bare minimum requirements isn’t enough. We want to exceed quality and compliance standards and, in doing so, position ourselves to serve clients at the absolute highest level for the long term.

Staying Ahead in a Complex Landscape: Agno’s Commitment to Excellence

Agno’s forward-thinking culture empowers us to deliver proactive solutions to our clients, answering the big questions before they’re asked. Staying ahead in this landscape requires the right expertise, modern equipment, and a commitment to do whatever it takes to deliver the services our clients need to see their projects through –– today, tomorrow, and ten years from now.

Sheldon Huang, EVP: Our commitment to excellence can be seen from the moment you walk into our facilities. Our quality assurance and control measures are among the most robust in this sector. All buildings meet CDMP, NMPA, and EHS regulations to streamline client projects and deliver safe, effective final products.

Brian Treco, Ph.D: Many Western facilities have older infrastructure, but when you see Agno’s China facilities for yourself, the difference is remarkable. The equipment and process groups rival any biotech and pharmaceutical companies in the West. And because resources go further in China than here in the U.S. or Europe, we’ve been able to build top-of-the-line facilities that go above and beyond regulatory standards to execute client projects.

Another hallmark of China’s drug development practices is its long-term view. They know they must invest in their buildings, infrastructure, and equipment, or they’ll be left behind. Because they’re looking long-term, they’re willing to spend the money upfront that others aren’t willing to do. As a result, they’ve got the best facilities and equipment, which significantly benefit our clients.

Shamim Ahmed, Ph.D: Automation is a key feature of our China facilities. Of course, automation reduces human intervention, so you need fewer people to work, and you save money. But because we’re working with sterile products, we need automation to guarantee sterility. Many facilities in the West are older and don’t have these automation capabilities. At Agno’s automated China facilities, there’s no risk of accidental human intervention. We can confidently guarantee sterility for a fraction of the cost and in less time than in other parts of the world.

Ensuring Quality and Excellence at Every Step with Agno Pharmaceuticals

Sheldon Huang, EVP: Experience is a key differentiator in this market. The team at Agno has decades of experience working in the U.S., which means we understand regulatory compliance issues better than anyone else. We offer end-to-end service and champion client projects from start to finish with expertise and equipment that can’t be rivaled.

Robert W. Lee, Ph.D:  Agno takes quality very seriously. You must have a quality-first mindset, building quality into projects from the beginning. This company’s culture is founded on excellence and innovation. You see that in how we handle RSMs, intermediates, and beyond.

Brian Treco, Ph.D: Today, pharmaceutical companies have more choices than ever for CDMOs to produce RSMs and intermediates. That means it’s a lot easier to make a bad choice than it’s ever been. You want to choose a company that’s proven they can execute, and our success rate is second to none.

Trust Agno with Your Next Project

At Agno, we believe in speed, accuracy, flexibility, and quality. We take ownership of our client projects; your success is our success. We’ve adopted a can-do attitude since we first began in this industry. Whatever the question, our answer is always “yes.” We create solutions that meet client needs and demands to see their project succeed, no matter what it takes.

Agno Pharmaceuticals is more than a partner. We are an extension of your development and manufacturing capability and capacity. From preclinical to commercial, RSMs and intermediates to packaging, we ensure excellence at every step.