Amador Bioscience Inaugurates GxP Bioanalytical Laboratory in Germantown, Maryland

The opening ceremony was held at Andu’s laboratory in Gaithersburg, Maryland, on the afternoon of October 28 (Eastern Time). Distinguished guests from institutions and organizations such as the Belgian Embassy, the U.S. Food and Drug Administration (FDA), leading biopharmaceutical companies, and local government authorities in Maryland were invited to attend the opening celebration and ribbon-cutting ceremony:

Major General Estella Jones, D.V.M., Deputy Director of the Office of Counterterrorism and Emerging Threats and the Office of the Chief Scientist within the FDA’s Office of the Commissioner;

John Baekelmans, Science and Technology Counselor at Flanders Investment & Trade

Bart Boschmans, Economic Counselor of Flanders Investment and Trade

Marc Elrich, County Executive of Montgomery County, Maryland; Dr. Lorin Roskos, Senior Vice President of Exelixis Inc.;

Dr. Koustubh Ranade, Vice President and Head of Translational Medicine at Immunocore;

Dr. Binodh DeSilva, Vice President of Bristol-Myers Squibb and President (2017) of the American Association of Pharmaceutical Scientists;

Dr. Honghui Zhou, Vice President and Head of Clinical Pharmacology and Toxicology at Keyuan Pharmaceutical.

Opening Ribbon-Cutting Ceremony

As a preferred partner for the successful development of innovative drugs, Andu Biosciences has established an ecosystem of translational and clinical development services in multiple biotechnology hubs across China, the United States, and Europe over the past four years, providing global support for innovative drugs from preclinical stages to market launch.

Montgomery County Executive Marc Elrich Presents Award to Andu Biologics

“The opening of the Maryland laboratory marks a significant milestone in Andu’s establishment of a global clinical development services ecosystem,” stated Ms. Chen Xiaomin, Chief Operating Officer of Andu Bio, in her address. “Andu boasts world-class capabilities in bioanalysis, biomarkers, and clinical development. Our team possesses exceptional technical expertise and extensive experience. We are confident that these strengths will powerfully drive biopharmaceutical companies both regionally and globally to achieve their development objectives, now and in the future.”

Ms. Chen Xiaomin, Chief Operating Officer of Andu Bio

The grand opening of Andu’s Maryland Bioanalysis and Biomarker Laboratory marks a significant milestone in the company’s development. Under the leadership of Dr. Meina Liang, Chief Technology Officer of Andu Biologics and President of Bioanalysis and Biomarkers, and Rafiq Islam, Vice President of Maryland Bioanalysis and Biomarkers, the laboratory plans to recruit more than 100 scientists by the end of 2023.

Dr. Mei-Na Liang, Chief Technology Officer and President of Bioanalysis and Biomarkers at AnDu Biosciences, stated in her address: “AnDu’s core values are integrity, excellence, collaboration, and courage. The global bioanalysis and biomarkers team will uphold these principles, focusing on scientific excellence and cutting-edge technology, compliance and quality aligned with global standards, and efficient processes, to provide comprehensive services that accelerate new drug development.”

Dr. Meina Liang, Chief Technology Officer of Andu Bio

The core members of the Maryland-based Bioanalysis and Biomarkers team consist of scientists with extensive industry experience in this field. They provide professional, compliant, timely, and effective services throughout the drug development and regulatory processes across multiple therapeutic areas, including monoclonal antibodies, bispecific antibodies, fusion proteins, enzymes, peptides, antibody-drug conjugates (ADCs), cell and gene therapies, oligonucleotides, and vaccines. By collaborating closely with the company’s global teams specializing in bioanalysis and biomarkers, clinical pharmacology, biostatistics, regulatory affairs, and clinical research, they deliver comprehensive solutions for the clinical development of pharmaceutical products to their partners.

Maryland Laboratory offers advanced bioanalytical and immunogenicity testing services, including flow cytometry, digital PCR, qPCR, mass spectrometry, ligand-binding assays, and cell-based assays. Leveraging these cutting-edge technologies, Andu Bio’s team of experts can tailor bioanalytical strategies to support regulatory submissions, mitigate risks, and facilitate the safe and efficient market launch of drugs under development.

Visit to the Maryland Laboratory

The Phase II expansion of the Maryland laboratory is scheduled for completion in early 2023, adding 10,400 square feet of space and rapidly accommodating an additional 75 scientists. This Phase II laboratory will focus on automated sample analysis, further enhancing Andu’s capacity to support large-scale clinical trials. Andu Bio’s regional service capabilities are continuously expanding; its GxP bioanalytical laboratory in Pleasanton, California, is set to become operational in December 2022. Upon completion of construction in 2024, Andu Bio’s European Center will also relocate to the Health Park in Diepenbeek, Belgium.

Andu Bio is a globally leading next-generation CRO in translational science and clinical development.

As the preferred partner for successful innovative drug development, Andu Bio provides end-to-end services in translational science, quantitative pharmacology, regulatory submissions, and clinical development that meet international standards for new drug development in China, Europe, and the United States. These services encompass clinical development strategy and execution from preclinical stages through to market launch, scientifically optimizing “dose selection, target selection, and patient selection,” while adhering to global quality execution standards to enhance the success rate of new drug R&D. Its client base ranges from leading biotech startups to multinational pharmaceutical companies. To date, the Andu team has successfully completed over 210 marketing authorization applications (NDAs, BLAs, MAAs) in Europe and the United States for clients both domestically and internationally.

It now operates facilities in multiple locations worldwide, including Pleasanton, CA; Ann Arbor, MI; Germantown, MD; and Richmond, VA in the United States; Hangzhou, Shanghai, and Beijing in China; and Limburg, Belgium in Europe.