American Marconi Wireless News - Bora Biologics Successfully Completes 2,000L Engineering and Scale-Up Run in San Diego, Reinforcing Commercial-Scale Readiness

The engineering run confirms operational readiness of the expanded mammalian manufacturing suites and validates the facility's integrated upstream, downstream, and quality systems at commercially relevant scale. The campaign also included scale-up of the TX05 (trastuzumab biosimilar) process from 1,000 liters to 2,000 liters, demonstrating the suite's capability to support licensure-stage manufacturing at increased batch volumes and reinforcing Bora Biologics' expertise in technology transfer, process scale-up, and cross-functional execution at commercial scale.

"Our clients are prioritizing partners who are already operating at scale-not preparing for it," said John Mosack, General Manager and Vice President, San Diego. "This successful 2,000-liter run demonstrates that our expanded infrastructure is fully operational and ready to support late-stage and commercial programs."

The San Diego expansion was designed to support late-stage clinical supply, PPQ campaigns, and commercial manufacturing, with material and personnel flows enabling concurrent multi-product operations, appropriately scaled utilities, and built-in infrastructure redundancy.

With capacity spanning 500L through 2,000L single-use bioreactors-and facility design engineered to accommodate future 5,000L configurations-the site provides sponsors with scalable capacity supported by commercial-grade quality systems.

In parallel, Bora Biologics collaborates with Bora Pharmaceuticals' FDA-approved sterile manufacturing facility in Baltimore, Maryland, providing integrated U.S.-based fill-finish capabilities. Together, the San Diego drug substance platform and Baltimore drug product capabilities offer sponsors a coordinated, domestic biologics manufacturing solution from bulk production through final sterile fill.

By completing engineering runs ahead of client demand, Bora Biologics enables sponsors to enter technology transfer and PPQ planning with reduced execution risk.

This scale up milestone follows Bora Biologics' recent TX05 resubmission filing, further demonstrating the maturity of the San Diego mammalian manufacturing suites and the robustness of the site's quality systems at commercial scale. While TX05 is separate from Bora Biologics' CDMO portfolio, the filing underscores the facility's readiness to support licensure stage programs and operate under regulatory scrutiny.

"Commercial manufacturing success depends on more than reactor volume," said Stephen Lam, Chief Executive Officer. "It requires disciplined manufacturing execution, uncompromising adherence to quality systems, infrastructure designed for sustained commercial cadence, and a site that is always inspection ready. That is the environment we have built in San Diego."

Completed in January 2026, the $30 million expansion was executed in anticipation of increasing demand for U.S.-based late-stage and commercial biologics manufacturing capacity.

Recent shifts in global trade policy and tariff announcements have further underscored the importance of domestic manufacturing infrastructure for biologics sponsors. As sponsors reassess reliance on overseas biologics capacity in response to evolving trade dynamics, FDA-approved U.S.-based capacity has become an increasingly strategic component of long-term manufacturing planning.

With validated 2,000-liter drug substance capability in San Diego and integrated U.S. fill-finish support in Baltimore, Bora Biologics is positioned to support sponsors seeking secure, commercially ready domestic manufacturing solutions.

By investing ahead of demand and validating the facility at full 2,000-liter scale, Bora Biologics positions itself to support sponsors approaching:

- Phase III
- BLA submission
- PPQ execution
- Commercial launch

"We're not asking sponsors to plan around future capacity," added Marc Goemans, Chief Commercial Officer. "We've already built and validated it."

About Bora Biologics
Bora Biologics is a global CDMO offering agile, comprehensive end-to-end solutions for biopharma companies worldwide. With a proven track record of over 100 successful cGMP manufacturing batches, Bora Biologics leverages its state-of-the-art, FDA-registered facility in the U.S. and deep expertise in biologics development and manufacturing-including its own FDA-licensed and Health Canada approved product-to enhance time and cost efficiencies while ensuring effective pathways to market for its clients. Bora Biologics combines innovative early-phase development and late-stage manufacturing capabilities with the expertise and reputation of Bora Pharmaceuticals for flexible and scalable fill/finish services, including stability testing and final packaging of clinical and commercial products. Bora Biologics is a DBA of Tanvex BioPharma USA, Inc.

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SOURCE: Bora Biologics

View the original press release on ACCESS Newswire

S.Gregor--AMWN