Following the announcement of AGC Biologics strategic partnership with Pyramid Pharma Services, leaders from both organizations sat down to discuss what this collaboration means for drug developers seeking a more integrated U.S.-based manufacturing pathway.
Below is the full interview with Ben Clauberg, Vice President of Business Development at AGC Biologics, and Brooke Marshall, Vice President of Business Development at Pyramid Pharma Services.
As drug developers face increasing pressure to move quickly, they still must manage quality steps, regulatory expectations, and supply chain risks. How does an integrated AGC-Pyramid model change the way clients can plan their path from drug substance to drug product?
Ben Clauberg, VP of Business Development, AGC Biologics:
We’ve heard from developers that they feel forced to choose between an “all-under-one-roof” model that provides end-to-end service but might lack deep specialization in sterile fill-finish, or juggling multiple independent vendors without a clear understanding of potential operational friction.
This new model offers a coordinated pathway, meaning we are establishing streamlined ways of working so that we can serve customers efficiently and as one cohesive unit rather than two separate companies. Clients get this fully integrated supply chain under a single contract, like they would with an existing end-to-end provider. The difference from other market providers is the quality, because now developers can plan their path with confidence that every step is being handled by top-tier specialists that will accelerate timelines without compromising on quality or regulatory requirements.
Brooke Marshall, VP of Business Development, Pyramid Pharma Services:
Drug developers are under tremendous pressure to accelerate timelines while minimizing technical, regulatory, and supply chain risk. Traditionally, managing separate drug substance and drug product providers can introduce handoffs, communication gaps, and delays at critical points in development.
The integrated AGC-Pyramid model changes that dynamic by providing clients with a coordinated path from drug substance through drug product manufacturing. Our teams work collaboratively from the earliest stages of a program, aligning technical strategy, project planning, quality expectations, and regulatory considerations. This enables earlier identification of potential risks, more efficient technology transfer, and better-informed decision-making throughout development.
Ultimately, the partnership allows our clients to spend less time managing vendors and more time advancing their therapies to patients.
What are you hearing from drug developers around U.S.-based manufacturing, supply chain security, and geographic flexibility, and how did those needs influence the decision to expand AGC’s U.S. offering through this partnership?
Ben Clauberg:
We have seen a significant surge in demand from biologics developers looking for robust, U.S.-based options to secure their supply chains, navigate tariff exposures, and manage concentration risk. But developers don’t want to be locked into one single geography. They want regional flexibility.
We listened to those needs, and they directly accelerated our decision to establish this strategic partnership. By combining the drug substance mammalian and microbial cGMP manufacturing available at our Seattle, WA site with Pyramid’s state-of-the-art cGMP facility in Costa Mesa, Cali., we have a new West-Coast, end-to-end, all-in-USA manufacturing pipeline.
Where does Pyramid create the most value once a client’s program moves from drug substance into sterile drug product manufacturing?
Brooke Marshall:
Pyramid creates the most value during the transition into sterile drug product manufacturing, where the complexity of development increases and execution becomes critical to maintaining timelines and product quality.
Our team engages early to help optimize the manufacturing strategy, ensuring the formulation, fill/finish process, container closure system, and analytical approach are aligned for successful scale-up and commercialization. By identifying potential manufacturing challenges early, we help reduce risk, avoid delays, and improve overall program execution.
With deep expertise in sterile manufacturing, process validation, technology transfer, lyophilization, and commercial supply, we provide the technical guidance and operational flexibility clients need as their programs advance. Our experienced teams work closely with clients to navigate changing requirements, solve challenges efficiently, and maintain momentum from development through commercialization.
Ultimately, Pyramid’s value lies in delivering high-quality sterile manufacturing with the responsiveness, technical expertise, and operational excellence that help clients bring therapies to patients faster and with greater confidence.
Where do handoffs between drug substance and drug product typically create complexity or risk, and how does this partnership help reduce that burden for clients?
Ben Clauberg:
Having to manage two separate suppliers for drug substance and drug product can create a higher risk of delays. In our integrated setup, AGC Biologics manages all activities with Pyramid under one contract to ensure quicker time to IND, and at the same time, reduces the financial risk exposure for our customers.
We have defined a clear path forward of how we will be working together, already proven by our other existing partnership in Europe.
Brooke Marshall:
The transition from drug substance to drug product is one of the most critical points in the development lifecycle. It’s where information, materials, and technical knowledge must transfer seamlessly between organizations, and if that coordination isn’t well managed, it can lead to delays, rework, additional costs, or regulatory challenges.
Common areas of complexity include aligning manufacturing timelines, transferring process knowledge, coordinating analytical methods and material specifications, managing logistics and cold chain requirements, and ensuring quality and regulatory expectations are consistent across both organizations.
Our partnership helps reduce that burden by creating a more coordinated experience for the client. Rather than managing two independent manufacturers, clients benefit from closer alignment between our technical, quality, and project management teams. We communicate proactively, coordinate timelines, and address potential issues early, allowing technology transfer and manufacturing activities to progress more efficiently.
How does offering this pathway through AGC’s project management structure simplify the experience for developers?
Ben Clauberg:
We hear from drug developers that they are juggling complex programs with limited bandwidth. Our project management approach is designed to remove that operational burden.
In practice, the customer experience is tailored for each project. Our dedicated project management teams can handle the entire subcontracting process behind the scenes, including technical alignments, shipments, slot allocations, and everyday logistics as part of this single contract. If the customer wishes to be more involved, our project managers know how to integrate them more directly into those activities. We can adjust to preferences while keeping the process as smooth as possible.
While we build processes like this to minimize hiccups, our project managers are dedicated problem-solvers and work with the team and customers to work through any development that might require quick resolution.
Pyramid’s capabilities span vials, lyophilized products, pre-filled syringes, cartridges, device assembly, labeling, packaging, and analytical services. How does that breadth of support help clients plan beyond the immediate clinical batch?
Brooke Marshall:
Our broad capabilities allow clients to remain with the same manufacturing partner as their programs evolve. Whether a product begins in a vial and later transitions to a pre-filled syringe or autoinjector, or progresses from clinical manufacturing to commercial-scale production, we have the expertise and infrastructure to support that evolution. In addition to sterile fill/finish, we offer lyophilization, cartridges, device assembly, labeling, packaging, and analytical services, providing a comprehensive solution as product and market requirements change.
Planning with commercialization in mind from the outset can reduce future technology transfers, simplify regulatory strategy, and minimize supply chain complexity. By supporting clients across multiple stages of development and commercialization, we help create continuity, reduce risk, and provide the flexibility needed to adapt as programs mature.
Ultimately, our breadth of capabilities allows clients to focus on advancing their therapies, knowing they have a manufacturing partner that can grow alongside them throughout the product lifecycle.
How can earlier alignment between drug substance and drug product teams help clients prepare for later-stage clinical and commercial milestones?
Brooke Marshall:
Earlier alignment between drug substance and drug product teams helps establish a strong foundation for the entire development program. Decisions made early such as formulation strategy, manufacturing process, analytical methods, container closure selection, and supply planning can have a significant impact on downstream clinical and commercial success.
Ultimately, early collaboration creates a more efficient development process, giving clients greater confidence that they’re building a scalable manufacturing strategy capable of supporting both near-term milestones and long-term commercial success.
Ben Clauberg:
I would echo what Brooke said and add this proactive alignment ensures that complex formulations and process developments are stress-tested and optimized long before reaching later-stage clinical and commercial milestones.
Sterile fill-finish is an incredibly unforgiving process with an extraordinarily thin margin for error. By aligning our drug substance teams in Seattle with Pyramid’s analytical, formulation, and sterile fill-finish experts early on, we build a seamless bridge from early development to commercial supply.
What should clients be thinking about earlier when it comes to tech transfer, fill-finish format, lyophilization strategy, device compatibility, and commercial readiness?
Brooke Marshall:
One of the biggest opportunities for drug developers is to begin thinking about commercial readiness much earlier in development. Decisions made during the preclinical or early clinical stages—such as selecting a fill-finish format, evaluating the need for lyophilization, choosing a container closure system, or considering future device compatibility—can significantly influence timelines, costs, and the success of later-stage manufacturing.
It’s also important to plan for technology transfer early. Ensuring that manufacturing processes, analytical methods, raw materials, and quality expectations are well defined helps reduce risk as programs scale and move through clinical development toward commercialization.
Clients should also consider whether the manufacturing strategy they choose today will support where they want the product to be in three to five years. For example, will the selected vial format ultimately transition to a pre-filled syringe or autoinjector? Is the process scalable? Are the analytical methods and control strategy appropriate for commercial production?
Taking a lifecycle approach from the outset helps avoid unnecessary technology transfers, reduces redevelopment work, and creates a smoother path through process validation, regulatory approval, and commercial launch. By asking these questions early, companies can make decisions that not only meet immediate clinical needs but also position their programs for long-term success.
If a drug developer remembers one thing about the value of the AGC Biologics and Pyramid Pharma Services partnership, what should it be?
Ben Clauberg:
Expertise is earned, and you don’t have to sacrifice specialization to get integration.
With this partnership, you aren’t getting a “check-the-box” fill-finish service tacked onto a portfolio. You are getting a streamlined, end-to-end U.S. supply chain that combines your friendly CDMO expert in drug substance manufacturing with Pyramid’s decades of sterile drug product expertise. And all protected by a single contract and structured to mitigate your financial and operational risks.
Brooke Marshall:
Together, AGC Biologics and Pyramid Pharma Services provide complementary expertise across the manufacturing lifecycle, from drug substance through sterile fill/finish and commercial supply, while maintaining a shared focus on quality, communication, and client success.
At the end of the day, our goal is simple: make it easier for clients to move their therapies from development to patients by providing an integrated manufacturing experience, proactive collaboration, and a long-term partnership that supports them from early clinical development through commercialization.
As drug developers continue to navigate evolving expectations around speed, quality, and supply chain resilience, the AGC Biologics and Pyramid Pharma Services partnership offers a more coordinated U.S.-based pathway from drug substance through sterile drug product manufacturing. By aligning AGC’s drug substance expertise with Pyramid’s fill-finish, device assembly, labeling, packaging, and analytical capabilities, the collaboration is designed to help clients reduce complexity, strengthen planning, and move critical therapies forward with greater confidence.
To learn more about the AGC Biologics and Pyramid Pharma Services partnership, contact Pyramid Pharma Services or connect with the AGC Biologics team.
Frequently Asked Questions
What sterile fill-finish capabilities does Pyramid Pharma Services offer?
Pyramid Pharma Services provides sterile fill-finish services for liquid and lyophilized vials, pre-filled syringes, and cartridges, along with device assembly, labeling, secondary packaging, and analytical services.
How does Pyramid Pharma Services support drug developers moving from drug substance to drug product?
Pyramid supports drug developers by providing sterile drug product manufacturing expertise, scalable fill-finish capabilities, technology transfer support, and services that help bridge development, clinical supply, and commercial readiness.
Why is U.S.-based sterile fill-finish important for drug developers?
U.S.-based sterile fill-finish can help drug developers improve supply chain flexibility, reduce geographic risk, and support programs that require or prefer domestic drug product manufacturing.
What types of programs can Pyramid support through this partnership with AGC Biologics?
Through the partnership, Pyramid can support drug developers seeking a more coordinated U.S.-based pathway from AGC’s drug substance development and manufacturing services into Pyramid’s sterile drug product manufacturing, fill-finish, device assembly, labeling, and packaging capabilities.
How can early fill-finish planning help drug developers prepare for later-stage or commercial supply?
Early fill-finish planning can help drug developers evaluate presentation format, lyophilization needs, device compatibility, technology transfer requirements, scalability, and long-term commercial readiness before those decisions create timeline or operational challenges.