Bora Biologics Completes 2,000L Expansion in San Diego

Successful engineering run reinforces facility's commercial-scale readiness for late-stage and launch-ready biologics manufacturing.

Apr. 6, 2026 at 11:50am

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Bora Biologics, a global CDMO, has successfully completed a 2,000-liter engineering and scale-up run at its FDA-approved manufacturing facility in San Diego. The milestone validates the expanded facility's operational readiness and ability to support late-stage clinical supply, process performance qualification (PPQ) campaigns, and commercial manufacturing for biopharmaceutical clients.

Why it matters

The completion of this 2,000-liter run demonstrates that Bora Biologics' San Diego facility is fully operational and capable of handling large-scale commercial biologics production. This is crucial as sponsors increasingly prioritize partners who can already operate at scale, rather than those still preparing for it. The facility's expanded capacity and integrated quality systems position Bora Biologics to support sponsors through late-stage development, regulatory filings, and commercial launch.

The details

The engineering run confirmed the operational readiness of Bora Biologics' expanded mammalian manufacturing suites and validated the facility's integrated upstream, downstream, and quality systems at commercially relevant scale. The campaign also included scaling up 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.

  • The $30 million expansion was completed in January 2026.
  • The successful 2,000-liter engineering run was conducted in April 2026.

The players

Bora Biologics

A global CDMO offering end-to-end solutions for biopharma companies, with a state-of-the-art, FDA-registered facility in the U.S.

John Mosack

General Manager and Vice President of Bora Biologics' San Diego facility.

Stephen Lam

Chief Executive Officer of Bora Biologics.

Marc Goemans

Chief Commercial Officer of Bora Biologics.

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What they’re saying

“Our clients are prioritizing partners who are already operating at scale-not preparing for it. This successful 2,000-liter run demonstrates that our expanded infrastructure is fully operational and ready to support late-stage and commercial programs.”

— John Mosack, General Manager and Vice President, San Diego

“Commercial manufacturing success depends on more than reactor volume. 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.”

— Stephen Lam, Chief Executive Officer

“We're not asking sponsors to plan around future capacity. We've already built and validated it.”

— Marc Goemans, Chief Commercial Officer

What’s next

Bora Biologics will continue to support sponsors approaching late-stage clinical trials, BLA submissions, PPQ execution, and commercial launch with its validated 2,000-liter drug substance capability in San Diego and integrated U.S. fill-finish support in Baltimore.

The takeaway

Bora Biologics' successful completion of a 2,000-liter engineering run at its San Diego facility demonstrates the company's readiness to support biopharmaceutical sponsors with secure, commercially viable domestic manufacturing solutions, including late-stage clinical supply, regulatory filings, and commercial launch.