Contract Pharma recently spoke with Dr. Lidia Serina, Head of Development at Simtra BioPharma Solutions, about the company’s strategic expansion into development and pre-commercial services. With over 25 years of experience in pharma and biotech, Dr. Serina discusses the sterile injectables market, trends in antibody-drug conjugates (ADCs), supply chain challenges, and how Simtra is leveraging its dual-site expertise to streamline development timelines and meet growing regulatory demands.

Contract Pharma: Let’s start with your background. How did you come to your current role at Simtra, and what’s the company focused on today?

Lidia Serina: I joined Simtra in August 2024. My background is in science—I have a PhD in biochemistry and did postdoctoral work in cancer genetics before moving into industry. I’ve worked for over 25 years in pharma, including at GSK, Sanofi, and smaller biotech firms. More recently, I’ve focused on the CDMO space.

At Simtra, I lead the development and pre-commercial services team. Our work spans early process development—including analytical work—all the way to late Phase III. We handle non-GMP development, clinical manufacturing, and tech transfer. Essentially, we manage the entire lifecycle up to commercial readiness.

Simtra itself is the former contract manufacturing arm of Baxter, now owned by two U.S.-based private equity firms. We’re focused exclusively on sterile injectables—drug product manufacturing, fill/finish, and lyophilization—ranging from small to large-scale commercial volumes. We operate two sites: one in Halle, Germany, and one in Bloomington, Indiana. Both offer development services from preclinical through commercial. The Halle site is particularly notable for its high-containment capabilities, allowing us to handle highly potent cytotoxic molecules. For example, we manufacture six of the thirteen commercial ADCs on the market today at that facility.

Contract Pharma: Simtra recently launched a new development and pre-commercial business unit. What prompted that move?

Lidia Serina: We already had development services at both sites, but we saw the need to elevate and unify that work under a focused business unit. Historically, Simtra concentrated on commercial manufacturing and had few clinical projects. Now, we’re putting more emphasis on development to deepen our scientific engagement with clients and build long-term relationships.

This shift adds the “D” to our CDMO offering. By supporting clients earlier in their product lifecycle, we create future value and help them move more efficiently from molecule discovery to commercialization.

Contract Pharma: What trends are driving growth in the sterile space?

Lidia Serina: A major trend is the rise of ADCs—complex biological molecules that combine antibodies with cytotoxic payloads to target cancer cells. Although ADCs have been around for over a decade, recent regulatory approvals and their relevance in oncology—which remains a leading cause of death—are accelerating demand.

Simtra has been providing fill/finish services for ADCs for 10 years. Now, we want to support clients even earlier in their pipeline, not just in commercial manufacturing. This positions us as a strategic partner in advancing oncology treatments and public health more broadly.

Contract Pharma: How is Simtra helping shorten development timelines compared to others in the market?

Lidia Serina: Drug development can take 10–15 years from early clinical trials to market. Regulators are pushing for faster timelines, and so are we. One way we help is by expanding our end-to-end capabilities to streamline handoffs between development stages.

For instance, in Halle, we’re building a new bioconjugation suite to manufacture ADC drug substances in addition to drug products. This allows us to handle more of the development process on-site, reducing delays and improving coordination. It’s about creating seamless transitions from one phase to the next.

Contract Pharma: What are some regulatory challenges in the ADC space?

Lidia Serina: The biggest challenge is stability. ADCs are highly sensitive to light and temperature. That means we need to partner closely with clients to fully understand their critical process parameters and quality attributes. This ensures we meet all regulatory requirements while maintaining the integrity of the molecule.

Contract Pharma: Let’s talk about the supply chain. With so many disruptions in the market, how is Simtra managing risk while meeting client expectations?

Lidia Serina: The sterile injectable space presents two main challenges: maintaining an aseptic environment and managing the supply chain for temperature-sensitive materials.

We address this through facility design and digital optimization. We’ve invested in lean manufacturing, digital tools, and AI to make our operations more resilient and efficient. Safety is also a key focus, especially with cytotoxic ADCs. Our facilities are built to protect both product and personnel.

With more than 65 years in sterile injectables, Simtra brings deep compliance expertise and scientific knowledge. Our two sites operate in synergy, and our ongoing expansions ensure we stay ahead of both regulatory requirements and client needs.

Contract Pharma: You’ve worked on both the pharma and CDMO sides of the industry. How does that experience shape your perspective?

Lidia Serina: It’s been invaluable. In big pharma, you’re focused on your own molecule. In the CDMO world, you’re managing many molecules and clients at once. It’s a faster pace, and the expectations are different.

Clients today aren’t just looking for a manufacturer—they want a partner with deep technical expertise. At Simtra, our clients expect us to be the best at sterile injectables, and that means delivering scientific excellence, speed, flexibility, and a collaborative mindset. That’s what makes this work so exciting.