An interview with:
Vadims Dvornikovs, Ph.D., Senior Director of Business Development
Robert W. Lee, Ph.D., SVP, Business Development
Shamim Ahmed, Ph.D., EVP, Pharmaceutical Development
Bin Li, Ph.D., EVP, Chemistry R&D
Sheldon Huang, EVP & General Manager, Manufacturing
Brian Treco, Ph.D., VP, Business Development

Beta-lactam manufacturing is a niche market with unique challenges and production hurdles. Agno Pharmaceuticals knows your product development needs and has developed specific processes, protocols, and infrastructure to ensure we execute beta-lactam manufacturing to the highest standards. No matter what manufacturing obstacles come your way, Agno Pharma is prepared to do whatever it takes to see your product through to market safely and effectively.

Agno’s leadership team shares their thoughts on the challenges of beta-lactam manufacturing, highlighting how our CDMO is uniquely positioned to overcome product hurdles and successfully execute your project.

Strict Contamination Control

Vadims Dvornikovs, Ph.D. When producing beta-lactams (or any other pharmaceutical products), you don’t want any contamination from previous batches or materials that aren’t part of making this active pharmaceutical ingredient. Agno’s facility is a GMP facility. We make sure that whatever materials we bring in have been approved, segregated, and controlled. We record the material’s disposition, so when it’s been used, it’s recorded and properly disposed of. Every ounce is accounted for, which empowers us to know where our materials are used and stored, ensuring there’s no cross-contamination.

Robert W. Lee, Ph.D. Regarding beta-lactams, the question is simple: Can you make them, and do you have the dedicated facilities to do so? At Agno, the answer is always yes.

Shamim Ahmed, Ph.D. Yes, you need a dedicated facility. In some cases, our clients need a dedicated building for beta-lactam production. That’s Agno’s approach. We have entire buildings where the only thing we produce is beta-lactams, allowing us to ensure compliance and safety.

Sheldon Huang We understand the challenge of contamination control in beta-lactam manufacturing. Agno has isolated our warehouse lines and buildings to meet health and safety requirements, including the FDA’s controls.

Bin Li, Ph.D. It’s very challenging to synthesize beta-lactam compounds, but Agno is home to experienced chemists and specialized equipment that can tackle these complex projects. Compound that with our isolated facilities, and we’re perfectly positioned to serve our clients’ beta-lactam production needs.

Brian Treco, Ph.D. While there are many opportunities for beta-lactam production, there are far more clients seeking drug development and manufacturing that aren’t producing beta-lactams. Those clients absolutely do not want beta-lactams sharing a line or facility with their products. They want assurance that there will be no risk of any contamination creeping into their batches. That’s why Agno prioritizes dedicated beta-lactam facilities. We want to show all our clients, not only our beta-lactam clients, that complete separation and safety are built into our processes and infrastructure.

You can classify contamination control into a few categories: containment, handling, and facility design. At Agno, we believe in building quality into everything we do from the beginning, and that’s the approach we take with building design. We design our facilities for safety and contamination control from the outset instead of trying to retrofit them after the fact. Robust facility design is about protecting the quality and integrity of the batches, of course, but it’s also about protecting the people who work in our facilities. With the right design and controls, we can accomplish both.

Sustainability

Vadims Dvornikovs, Ph.D. Agno Pharma operates using state-of-the-art technologies to minimize the use of materials that could pose potential dangers in manufacturing. It’s in everyone’s best interest to use those materials as efficiently as possible to minimize time spent handling materials, disposal costs, and material waste, reducing the resources that are used. We follow the best industry practices and consciously choose to use materials efficiently to manufacture beta-lactams.

Robert W. Lee, Ph.D. More and more, clients care about minimizing their carbon footprint. They want their drug development partners to have better infrastructure and processing, to be more sparing with resources, and to operate more efficiently without affecting quality. Agno hears those concerns, and we proactively take steps to minimize our negative impact on the environment and resource waste. We really challenge ourselves to make sure we’re not only in compliance with regulations and guidelines but are also responsible with what we’re releasing into the environment during production and manufacturing.

Brian Treco, Ph.D. Sustainability is often used as a marketing term to impress clients. But people forget the actual definition of sustainability; that is, that you’ll be able to operate effectively and efficiently not only today but tomorrow, five years from now, and thirty years from now. Sustainability is really about survivability. It’s not something that’s nice to have; it’s essential for success in this (and any) market.

Regulatory and Compliance Requirements

Sheldon Huang, Ph.D. At Agno, we have in-depth knowledge of the various regulations related to beta-lactam manufacturing and other areas of drug development. We understand and maintain the requirements of the FDA, CGMP, and EHS, protecting the environment, operator, and product.

In addition to in-house compliance, Agno ensures complete compliance from all our suppliers. We want full control over every facet of manufacturing to ensure quality for our clients from start to finish.

Vadims Dvornikovs, Ph.D. This applies to all Agno Pharma’s operations, not just beta-lactams. Our beta-lactam facility is a GMP facility that follows all cGMP. We have a history of successfully passing multiple regulatory inspections. Our track record proves we have the experience and expertise to maintain compliance at every stage of production and manufacturing.

Supply Chain and Raw Material Sourcing

Bin Li, Ph.D. At Agno, we build our own supply chains and are uniquely equipped to both produce and source RSMs. Not only have we developed a synthetic route to RSMs here in our facilities, but we also have partnerships with several suppliers to source these materials.

Brian Treco, Ph.D. Because we are in China, we have direct access to most, if not all, the raw materials that we’ll need for production. Because the materials are right here at our doorsteps, we don’t need extended lead times of weeks or months like our competitors. Our proposed lead times win hands down—not only for beta-lactams but for anything you’re trying to develop.

Shamim Ahmed, Ph.D. China is the best source for anything related to APIs, RSMs, or intermediates, so we face virtually zero issues with our supply chain. Our colleagues in China have a future-focused, proactive approach to manufacturing, which helps us stay ahead of potential shifts or demand changes. Let’s take packaging, for example. They’re not thinking about packaging needs a week from now. They’re thinking about secondary and tertiary packaging for the weeks and months ahead. That mindset positions Agno to be ready for whatever production issues might come our way.

Vadims Dvornikovs, Ph.D. To deliver the material to the client and to do it in an official, sustainable way, and to give the best value to the client, we have to start with materials that are relatively affordable while maintaining superior quality. Agno has a well-established chain of suppliers with whom we’ve maintained long-term relationships. We have an excellent sourcing team that can rapidly identify sources of available materials and quickly provide answers to our clients regarding whether we can take on their projects, given the availability of the raw materials for the project.

Complex Manufacturing Processes

Bin Li, Ph.D. Beta-lactams have a notoriously complex manufacturing process, but Agno has experienced synthetic chemists who can tackle this very challenging chemistry. Our track record demonstrates that we can make complex compounds, balancing cost and efficiency without sacrificing quality or safety. We’ve designed and designated production lines to meet the complex manufacturing requirements of our clients.

Vadims Dvornikovs, Ph.D. Like Bin said, Agno Pharma has extensive experience developing and manufacturing beta-lactams, which sets us apart from a CDMO that is just a general chemical manufacturer. Beta-lactams are complex organic molecules known to be unstable under various conditions. To manufacture them with high purity and reliability, the manufacturing processes have to be highly controlled. This means well-written, detailed batch records and degradation and stability studies of key intermediates and final materials to ensure that the final product is of high purity. Given the instability of the final beta-lactams and earlier intermediates, many of the impurities have to be identified and analytical methods developed and validated in order to control those impurities. This adds to the overall complexity of the manufacturing process.

Brian Treco, Ph.D. Most projects we take on involve complex manufacturing processes. When you couple that with the unique requirements of beta-lactam manufacturing, you further increase the difficulty and complexity of the project. Beta-lactam producers need to partner with an experienced company that invests in equipment, infrastructure, and the people doing the work. Agno is that company.

Executing Beta-Lactam Projects with Agno Pharmaceuticals

Agno Pharmaceuticals’ expertise and proactive strategies set us apart for beta-lactam manufacturing and other client projects. We have decades of experience in the U.S., and our partnerships in China allow us to meet client needs better, faster, and at a lower cost. We’re proactively building the infrastructure, equipment, and process design to be prepared for future client needs. Our team is prepared to find solutions to beta-lactam manufacturing challenges, no matter what it takes.

Agno is more than your drug development partner. We take ownership of our clients’ projects; your success is our success. With our resources, state-of-the-art technology, infrastructure, and seasoned expertise, Agno delivers tailored services for beta-lactam manufacturing and projects across the drug development spectrum.