Biocytogen Achieves Full AAALAC Accreditation, Strengthening Research Excellence

Biocytogen’s Boston Research Facility Earns AAALAC International Full Accreditation, Reinforcing Commitment to Scientific Excellence and Animal Welfare

Biocytogen has announced a significant achievement for its U.S. research operations, revealing that its Boston research facility has been awarded Full Accreditation by AAALAC International, one of the world’s most respected organizations dedicated to advancing excellence in laboratory animal care and use. The accreditation marks an important milestone for the company as it continues to expand its global drug discovery and translational research capabilities while maintaining rigorous standards of scientific quality, ethical research practices, and animal welfare.

The recognition highlights Biocytogen’s commitment to operating research programs that not only comply with regulatory requirements but also exceed industry standards through continuous improvement and adherence to internationally recognized best practices. As the company strengthens collaborations with pharmaceutical and biotechnology organizations around the world, the accreditation provides additional validation of its ability to deliver high-quality preclinical research services and innovative therapeutic discovery solutions.

A Major Milestone for Biocytogen’s Global Research Network

The Boston research facility plays a critical role within Biocytogen’s global operations. Serving as a strategic center for preclinical research and drug discovery activities in North America, the site supports a broad range of programs focused on advancing next-generation therapeutics across numerous disease areas.

The facility conducts a variety of in vivo studies that are essential to modern drug development, helping researchers evaluate the safety, efficacy, and biological activity of investigational therapies before they advance into human clinical trials. These studies support the development of diverse therapeutic modalities, including monoclonal antibodies, multispecific antibodies, antibody-drug conjugates (ADCs), cell therapies, and other innovative biologic treatments.

As demand continues to grow for advanced translational research and predictive preclinical models, Biocytogen’s Boston operation has become an increasingly important resource for pharmaceutical companies, biotechnology innovators, and academic researchers seeking to accelerate the development of new medicines.

The achievement of Full Accreditation from AAALAC International further strengthens the facility’s reputation as a trusted research partner capable of delivering scientifically rigorous and ethically responsible research services.

Understanding the Importance of AAALAC Accreditation

AAALAC International is widely regarded as the global gold standard for laboratory animal care and use programs. The organization evaluates research institutions, universities, pharmaceutical companies, biotechnology firms, and contract research organizations to ensure that animal research programs are conducted according to the highest standards of welfare and scientific responsibility.

Unlike mandatory regulatory inspections, AAALAC accreditation is a voluntary process. Organizations seeking accreditation undergo comprehensive evaluations that assess every aspect of their animal care and use programs, including facility operations, veterinary oversight, housing conditions, staff training, ethical review procedures, and overall commitment to continuous improvement.

Institutions that achieve accreditation demonstrate a willingness to go beyond minimum legal requirements and embrace best practices designed to promote animal well-being and support high-quality scientific outcomes.

The accreditation process involves extensive documentation reviews, on-site assessments, and ongoing monitoring to ensure sustained compliance with evolving standards and expectations.

For research organizations such as Biocytogen, AAALAC accreditation serves as an important external validation that research activities are conducted in an environment that prioritizes both scientific excellence and humane animal care.

Supporting Innovation Through Advanced Research Infrastructure

Biocytogen’s Boston facility contributes significantly to the company’s broader mission of enabling the discovery and development of innovative therapies for patients with serious diseases.

A key component of this mission is the company’s proprietary BioMice™ platform, which has become one of the industry’s most extensive collections of genetically engineered animal models. These sophisticated disease models are designed to closely mimic human biology and disease processes, allowing researchers to better understand disease mechanisms and evaluate potential therapeutic interventions.

The BioMice platform spans numerous therapeutic areas and provides valuable tools for studying complex diseases in oncology, immunology, autoimmune disorders, metabolic diseases, neuroscience, ophthalmology, and many other medical fields.

Such disease models play a crucial role in modern biomedical research by helping scientists identify promising drug targets, validate therapeutic hypotheses, and assess the potential effectiveness of new treatment candidates before clinical testing begins.

The availability of these advanced research models enables Biocytogen and its partners to generate more predictive data, potentially improving decision-making throughout the drug development process.

Combining Disease Models With Human Antibody Discovery Technologies

Beyond its disease model capabilities, Biocytogen has established itself as a leader in antibody discovery through the development of its proprietary RenMice® platform.

The RenMice technology is designed to facilitate the discovery of fully human antibodies, which are increasingly important in the treatment of cancer, autoimmune diseases, inflammatory disorders, and numerous other conditions.

Fully human antibodies offer several advantages compared with earlier generations of antibody therapeutics, including reduced risk of immune-related complications and improved compatibility with the human immune system.

By integrating the RenMice platform with its disease modeling expertise, Biocytogen provides partners with a comprehensive ecosystem for therapeutic discovery. Researchers can move from target identification and antibody generation to preclinical validation using integrated tools and workflows.

In recent years, the company has also incorporated artificial intelligence-driven technologies into its discovery processes. These AI-enabled platforms are designed to improve efficiency, enhance candidate selection, and accelerate the identification of promising therapeutic molecules.

Together, the BioMice platform, RenMice technology, and AI-powered discovery capabilities create a powerful framework for advancing innovative biologic therapies from early research through preclinical development.

Commitment to Animal Welfare and Responsible Research

Biocytogen leaders emphasize that scientific advancement and animal welfare are inseparable components of successful biomedical research.

According to Madeline Lee, Chief Operating Officer of Biocytogen Boston Corp., achieving Full AAALAC Accreditation represents an important validation of the company’s longstanding commitment to maintaining exceptional standards in both scientific research and animal care.

She noted that the accreditation reflects the organization’s dedication to responsible research practices, operational excellence, and continuous improvement. As Biocytogen expands collaborations with pharmaceutical and biotechnology partners around the world, the accreditation provides additional confidence that studies conducted at the Boston facility meet the highest standards of quality, ethical responsibility, and scientific rigor.

Lee also highlighted the importance of combining robust research infrastructure with advanced discovery platforms to help partners accelerate the development of transformative therapies for patients.

Her comments underscore the growing recognition within the life sciences industry that ethical animal care practices contribute directly to research quality. Healthy, well-cared-for laboratory animals are essential for generating reliable, reproducible, and scientifically meaningful data.

Consequently, organizations that prioritize animal welfare often strengthen the overall integrity and credibility of their research programs.

Enhancing Confidence for Pharmaceutical and Biotechnology Partners

The accreditation arrives at a time when pharmaceutical and biotechnology companies are increasingly focused on selecting research partners capable of delivering both scientific excellence and regulatory confidence.

Drug development has become more complex, expensive, and competitive than ever before. As a result, sponsors rely heavily on trusted research organizations to generate accurate and reliable preclinical data that can inform critical development decisions.

AAALAC accreditation serves as an important indicator that a research facility has implemented robust systems and processes designed to support high-quality research outcomes.

For Biocytogen’s global partners, the accreditation provides reassurance that studies conducted at the Boston facility are performed under internationally recognized standards for animal welfare, ethical conduct, and scientific quality.

This confidence is particularly important during translational research and preclinical development stages, where data generated from animal models often guide decisions regarding candidate selection, dosing strategies, safety assessments, and clinical development planning.

Accelerating the Development of Next-Generation Medicines

As the pharmaceutical industry continues to pursue increasingly sophisticated therapies—including multispecific antibodies, antibody-drug conjugates, cell therapies, and other advanced biologics—the need for predictive preclinical models and high-quality translational research continues to grow.

Biocytogen’s expanding portfolio of research platforms is designed to address these needs by helping partners generate actionable data more efficiently and with greater confidence.

The company’s capabilities support programs across a broad spectrum of therapeutic areas, including cancer, autoimmune diseases, inflammatory conditions, metabolic disorders, neurological diseases, and ophthalmic disorders.

By combining advanced disease models, fully human antibody discovery technologies, artificial intelligence-driven research tools, and a strong commitment to animal welfare, Biocytogen seeks to reduce development risks and improve the probability of success for innovative therapeutic programs.

The achievement of Full AAALAC International Accreditation represents more than a regulatory milestone—it reflects Biocytogen’s broader commitment to excellence across every aspect of its research operations.

As the company continues to expand its global partnerships and invest in advanced drug discovery technologies, the accreditation reinforces its position as a trusted collaborator for pharmaceutical and biotechnology organizations seeking innovative research solutions.

With a growing portfolio of disease models, cutting-edge antibody discovery platforms, AI-enabled capabilities, and now internationally recognized accreditation for animal care and research quality, Biocytogen is well positioned to support the development of next-generation medicines that address some of the world’s most challenging diseases.

The recognition further demonstrates that scientific innovation and responsible research practices can work hand in hand, helping accelerate the journey from scientific discovery to life-changing therapies for patients worldwide.

About Biocytogen

Biocytogen (SSE: 688796; HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen has established a dual-engine platform combining a fully human antibody library with an extensive target-humanized mouse model portfolio, enabling a systematic approach to accelerating global drug discovery and development.

Biocytogen has independently developed its proprietary RenMice® (RenMab®/RenLite®/RenNano®/RenTCR™/RenTCR mimic™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, hu-VHH discovery, and TCR mimic antibody discovery, and has established a sub-brand, RenSuper™ Biologics, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration.

As of December 31, 2025, more than 350 agreements for therapeutic antibodies and clinical assets—spanning co-development, out-licensing, and transfers—have been established globally, including landmark partnerships with leading multinational pharmaceutical companies (MNCs).

Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen, Jiangsu, Shanghai), the USA (Boston, San Francisco, San Diego), and Germany (Heidelberg).

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