GMP Manufacturing Suite Viewed from the Lobby at Bora Biologics’ Rockville, MD Facility, Featuring 5 × 2,000L Single Use Bioreactors

Expansion Scales U.S. Single-Use Drug Substance Capacity to 20,000 Liters Across Two FDA-Registered Facilities

San Diego, CA – ACCESS Newswire – July 13, 2026

Bora Biologics, a U.S.-based biologics CDMO engineered for licensed supply, today announced the expansion of its U.S. drug substance manufacturing platform through the addition of the Rockville, Maryland site. The addition strengthens the company’s U.S.-anchored BioSecure commercial platform and reinforces its long-term investment in domestic biologics manufacturing.

With the addition of Rockville, Bora Biologics scales its total offering of installed U.S. single-use bioreactor capacity to 20,000 liters — scalable to 30,000 liters — across two FDA-registered facilities in Rockville, Maryland and San Diego, California. The combined network includes seven 2,000L commercial bioreactors operating within a 100% single-use GMP architecture.

Unlike CDMOs built primarily for clinical supply, Bora Biologics is structured to support programs that intend to launch — aligning development strategy, global tech transfer, and GMP execution under one integrated quality system to reduce lifecycle switching risk and enable predictable commercial readiness.

The Rockville site is actively manufacturing commercial product and supports licensed commercial programs supplying six global markets. Across the combined U.S. platform, Bora Biologics has executed more than 200 GMP batches, including over 60 commercial batches, with 100% first-pass PPQ success.

The company has supported the development of more than 48 biologics and biosimilars, 74 CTA/IND submissions, and four BLA filings, completing 16 GMP tech transfers within the past five years.

“This expansion strengthens our ability to support late-stage and licensed programs within an inspection-proven, U.S.-anchored infrastructure,” said Stephen Lam, Chief Executive Officer of Bora Biologics. “As regulatory and policy environments increasingly prioritize secure domestic manufacturing, Rockville enhances our ability to deliver predictable launch execution with regulatory durability.”

The integrated platform operates with mature QMS systems refined through multiple regulatory inspections and provides end-to-end CMC, analytical, release, and stability support from IND through BLA.

“By expanding to 20,000 liters of U.S. single-use capacity across commercially active sites, we are strengthening our ability to capture and retain late-stage programs while reducing lifecycle risk for our partners,” added Marc Goemans, Chief Commercial Officer. “Rockville advances the depth, reliability, and long-term durability of our commercial platform.”

About Bora Biologics
Bora Biologics is a U.S.-anchored biologics contract development and manufacturing organization (CDMO) built for licensed supply. The company provides integrated services from early-stage development through process performance qualification (PPQ) and long-term commercial manufacturing.

With development capabilities in Zhubei, Taiwan and commercially executing drug substance facilities in Rockville, Maryland and San Diego, California, Bora Biologics offers a unified lifecycle pathway designed to reduce tech transfer risk and support launch readiness under one integrated quality system.

Across its platform, Bora Biologics has executed more than 200 successful cGMP manufacturing batches, including over 60 commercial batches, supporting three active commercial programs supplying six global markets. The company has supported the development of more than 48 biologics and biosimilars across monoclonal antibodies, bispecific antibodies, and related biologic modalities.

Through its strategic relationship with Bora Pharmaceuticals, clients also have access to scalable fill/finish capabilities, including stability testing and final packaging for clinical and commercial products.

Bora Biologics is a DBA of Tanvex BioPharma USA, Inc.

Website
www.borabiologics.com

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www.linkedin.com/company/bora-biologics/

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