FREDERICK, Md., Sept. 3, 2025 /PRNewswire/ -- BioFactura, Inc., a clinical‑stage biopharmaceutical company specializing in high‑value biosimilars and critical biodefense medical countermeasures, today announced the formation of Capitol Biologics, a new Contract Development and Manufacturing Organization (CDMO) division dedicated to supporting the process development, early‑phase clinical manufacturing, and analytical needs of emerging biotechnology companies and U.S. government agencies. Strategically located in the BioHealth Capital Region, Capitol Biologics combines technical excellence, regulatory expertise, and personalized collaboration to advance innovative biologics from lab bench to first‑in‑human studies.

Building on BioFactura's two decades of expertise in biologics development, Capitol Biologics will deliver full‑service, phase‑appropriate manufacturing solutions for monoclonal antibodies, recombinant proteins, and other complex biologics. The division combines advanced cell line development, upstream and downstream process optimization, GMP manufacturing, and extensive analytical and quality control capabilities under a unified quality management system aligned to global regulatory standards (FDA, EMA, ICH).

Located in the greater Washington, DC metropolitan area—within the BioHealth Capital Region and the I‑270 Biotech Corridor—Capitol Biologics is strategically positioned to provide streamlined logistical access to major pharmaceutical hubs, government facilities, and world‑class research institutions. The division will support both private‑sector biotech innovators and public health initiatives aimed at strengthening national preparedness.

President and CEO Darryl Sampey stated, "Transforming the biopharma development engine that BioFactura has built over the past 20 years into a pure-play service organization provides an incomparable value to early-stage ventures and initiatives. The depth of experience, know-how and capability that we have gained saves our clients both time and money that are in many cases existential to their survival and success."

"Capitol Biologics represents the next evolution of BioFactura's mission," said Dr. Jeffrey Hausfeld, M.D., M.B.A., F.A.C.S., Chairman of the Board and Chief Medical Officer of BioFactura. "We are combining our proven technical excellence in biologics development with a personalized, collaborative service model for our clients. Our goal is to help innovators advance their therapies to clinical reality faster, more efficiently, and with the highest quality standards. This new division allows us to share our expertise, infrastructure, and passion for science with the broader biotech community at a critical stage of their growth."

As entrepreneurs ourselves, we understand the needs of our clients. Our goal is to be "Fit For Purpose"! By our nature, we are problem solvers. Our aim is to efficiently deliver what our client's need, when they need it.

Capitol Biologics' culture of innovation and entrepreneurship offers a unique personalized experience that aligns with our client's motivations and needs, eliminates unnecessary friction, and addresses the real-world concerns that companies face every day. Our mission is to get our clients from concept to clinic…. seamlessly!

About BioFactura, Inc.
Founded in 2004, BioFactura develops and manufactures high‑value biosimilars and biodefense medical countermeasures using its proprietary StableFast™ Biomanufacturing Platform. The company's pipeline includes biosimilar candidates referencing products such as Stelara^® and Simponi^® as well as a novel smallpox therapeutic.

About Capitol Biologics
Capitol Biologics, a division of BioFactura, Inc., is a full‑service Contract Development and Manufacturing Organization (CDMO) focused on early‑phase clinical biologics manufacturing. Capitol Biologics' integrated capabilities span cell line development, process development, GMP manufacturing, comprehensive analytical services and clinical trial support. With a strategic location in Frederick, Maryland, and a commitment to quality, innovation, and client collaboration, Capitol Biologics guides products seamlessly from concept to clinic

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SOURCE BioFactura