The Albany Gazette - Bora Biologics Expands U.S. Commercial Manufacturing Platform with Addition of Rockville Site

NYSE - LSE

CMSC	0.11%	21.744	$
CMSD	-0.73%	21.82	$
RIO	1.43%	101.1	$
BCE	-0.09%	22.75	$
RBGPF	1.08%	70.5	$
BTI	1.01%	59.33	$
RYCEF	1.1%	20.85	$
GSK	1.49%	52.96	$
NGG	0.58%	80.88	$
AZN	0.87%	161.42	$
VOD	1.17%	16.19	$
RELX	0.14%	35.52	$
BCC	2.7%	86.6	$
JRI	1.17%	12.81	$
BP	-1.44%	41.63	$

Bora Biologics Expands U.S. Commercial Manufacturing Platform with Addition of Rockville Site

TECHNOLOGY 13.07.2026

Bora Biologics Expands U.S. Commercial Manufacturing Platform with Addition of Rockville Site

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

Text size:

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
LinkedIn
www.linkedin.com/company/bora-biologics/
CDMO Inquiries
[email protected]
Media Contact
[email protected]

SOURCE: Bora Biologics

View the original press release on ACCESS Newswire

(E.Taylor--TAG)

Featured

Nocturnal 'coffee frog' discovered in Costa Rica

A tiny greenish, noctural frog that thrives in coffee plantations has been discovered in the Costa Rica's central Pacific region, where it also faces risks from agrochemicals used in farming.

New to The Street Show 766 Broadcasts Tonight at 6:30 PM ET on Bloomberg Television, Featuring BioVie's Bezisterim Parkinson's Disease Clinical Results

Sponsored Programming Also Broadcasts Across Bloomberg Television in Latin America and MENA, Expanding the Global Reach of New to The Street's Featured Companies

Austrian writer Stefan Zweig, who fled Nazis, honoured in London

With its grand facade, the 1930s London mansion block looks like countless others. But one flat hides a tale of one of the darkest chapters in 20th century European history.

Military shake-up poses little threat to Ukraine's drone revolution

Zigzagging between robots, weapons and computers in his garage workshop, Ukrainian engineer Eduard Trotsenko was bubbling with excitement as he showed off his latest prototypes and dreamed of sci-fi-inspired futuristic ideas.