DCAT Week 2025: Maintaining Aseptic Integrity and Stability in Sterile Injectable Manufacturing

Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions, discusses the key challenges in aseptic processing for sterile injectables in an interview with BioPharm International® ahead of DCAT Week 2025, held March 17–20, 2025 in New York City. Among the primary hurdles are the preservation of aseptic conditions throughout complex, multi-hour manufacturing processes while ensuring product stability, especially for sensitive molecules such as antibody-drug conjugates (ADCs); upholding cold chain logistics to maintain temperature-sensitive products during processing and shipping across global supply chains; and adherence to stringent safety standards for highly potent and cytotoxic molecules to protect both the workforce and the final drug product.

To address these challenges, Simtra is leveraging advanced automation, digitalization, and lean manufacturing practices. This includes enhanced digital monitoring, robust technology transfer protocols, and facility designs tailored to mitigate risks. The company is also expanding its capabilities in highly potent and cytotoxic manufacturing, as well as dedicated suites for ADCs.

"In parallel to the digitalization environment, we are also improving the way we do technology transfer … from when we receive a molecule and a process from a client [to when] we transfer this knowledge onto our aseptic filling lines … we need to make sure that we understand the critical process parameters [and] the quality attributes of the molecule, so we are actually able to keep the stability of this molecule along the manufacturing process [even to] the patient, right when we ship the product to the patient," Serina says.

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About the speaker

Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions

Lidia Serina, PhD, is head of Development Services at Simtra BioPharma Solutions, leading a strategic area essential to the company’s mission. She partners with clients to develop high-quality injectable products and efficient manufacturing processes. With extensive experience in supply chain, vaccine R&D, quality and regulatory compliance, and both commercial and clinical manufacturing, Serina’s technical expertise spans a wide range of molecule types. Her leadership drives innovative solutions to the complex challenges of product development and manufacturing.