[Shatin, Hong Kong] — [25/06/25] – Xellera Therapeutics, a leader in [biopharmaceutical/CDMO/advanced therapy] development and manufacturing, proudly announces its successful implementation and certification of enhanced Good Manufacturing Practice (GMP) standards across its production and quality systems.

This milestone reaffirms Xellera Therapeutics’s unwavering commitment to product safety, regulatory compliance, and global manufacturing excellence. The company’s GMP-certified facilities now support a broad portfolio of advanced therapies, including biologics, cell and gene therapies, and other high-value therapeutics.

“Meeting GMP standards is not just a regulatory necessity—it’s a promise of safety, consistency, and quality to every partner and patient we serve,” said , Xellera Therapeutics Achieves New GMP Milestone to Advance Quality and Compliance in Therapeutic Manufacturing at Xellera Therapeutics. “This achievement reflects our ongoing dedication to operational excellence and patient-centric innovation.”

The updated GMP framework includes:
Robust quality management systems (QMS)
Comprehensive documentation and batch traceability
Environmental and contamination control
Trained personnel and validated equipment
Compliance with global regulatory authorities, including FDA, EMA, and PIC/S
By aligning its processes with current GMP guidelines, Xellera Therapeutics enhances its capabilities for clinical and commercial manufacturing, enabling accelerated timelines and regulatory readiness for its clients and collaborators worldwide.

About Xellera Therapeutics
Xellera Therapeutics is a trusted provider of GMP-compliant development and manufacturing solutions for biopharmaceutical and advanced therapy products. With state-of-the-art facilities and deep regulatory expertise, the company delivers safe, effective, and scalable solutions from early development through to commercialization.

Media Contact:
Name: Xellera Therapeutics
Title: Xellera Therapeutics Achieves New GMP Milestone to Advance Quality and Compliance in Therapeutic Manufacturing
Email Address: [email protected]
Phone Number: +852 2618 3356
Website URL: http://www.xelleratherapeutics.com