Charles River Partners with JADE Biomedical to Expand Biologics Capabilities

Rhea-AI Summary

Charles River Laboratories (NYSE: CRL) has formed a strategic partnership with JADE Biomedical to enhance its biologics testing capabilities. This collaboration aims to support the rising demand for biologics therapeutics, particularly in cell and gene therapies. JADE will expand its GMP product testing operations in Shanghai by opening a second facility, thereby increasing capacity for clients. The partnership combines both companies' expertise in navigating the complex global regulatory landscape, making them reliable partners to clients of any size.

Positive

• Strategic partnership with JADE Biomedical enhances biologics testing capabilities.
• Expansion of JADE's GMP product testing operations in Shanghai with a new facility.
• Collaboration addresses rising demand for cell and gene therapies.

Negative

• None.

Charles River Laboratories International, Inc. (NYSE: CRL) today announced that it has entered into a strategic partnership with JADE Biomedical (JADE), a provider of end-to-end quality management services for the biopharmaceutical industry. The partnership will expand Charles River’s biologics testing capabilities geographically and help to accommodate demand for biologics therapeutics, especially cell and gene therapies, reaffirming the company’s commitment as a global development partner. This strategic relationship will also enable JADE to expand their current global Good Manufacturing Practice (GMP) product testing operations in Shanghai into a second facility and further build upon its current offering of comprehensive biologics quality management and testing services.

As the biologics therapeutics industry across the globe continues to grow at a rapid pace, so does the demand for a reliable contract services partner. The recent growth in commercialization efforts in the cell and gene therapy market requires both scientific and regulatory expertise to navigate the complex, global regulatory environment. JADE’s deep understanding of global trends and the local environment, and its infrastructure designed to support clients of all sizes—from local start-ups to global organizations—makes it a highly valuable addition to Charles River’s network. The addition of a second testing facility, which will come online later this year, will provide additional capacity to better support clients’ growing needs. The new facility will offer GMP and Good Laboratory Practice (GLP) services to clients.

Approved Quotes

• “Around the world, R&D efforts for cell and gene therapies are in high demand. Companies are seeking global partners who understand the complexities of this market, while also knowing how to navigate the nuanced regulatory environment in their region. Working with JADE, we will be able to combine our expertise to provide localized knowledge with a deep scientific and regulatory network, positioning both organizations as go-to partners for clients in this competitive market.” – Birgit Girshick, Corporate Executive Vice President, Discovery and Safety Assessment, Biologics Testing Solutions, and Avian Vaccine Services, Charles River
• “JADE was founded with the purpose of serving the growing needs of the biopharmaceutical industry, not only in China, but internationally. JADE is a contracted Biologics Quality Organization, Bio-CQO ^R , where end-to-end quality and regulatory technical services are provided as an important addition to the biologics outsourced services industry, filling gaps in shortage of expertise and leadership in quality and compliance. We are extremely grateful to the conducive regulatory environment in recent years in China, and the trust of leading, global biopharmaceutical companies that have allowed us to form a unique service model and brand. To continue our growth in biologics therapeutics, especially in the gene and cell therapy space, we needed a partner with global reach. With an industry-leading portfolio of services and regulatory expertise, Charles River will help us support an increasing number of clients globally and locally.” – Claudia Lin, PhD, Founder and CEO, JADE Biomedical

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

About JADE Biomedical (JADE)

JADE Biomedical provides expert Quality, Regulatory and Analytical Testing Services to the Biopharmaceutical companies worldwide. It is the world’s first registered Biologics Contract Quality Organization, Bio-CQO^R. JADE service portfolio includes Quality Assurance, Regulatory Submission, QC Method Validation and Testing, general CMC and Analytical Development, Facility Design and Qualification, Cold Chain Management, etc.. JADE founder and leaders have extensive drug regulatory experience with agencies including NMPA, FDA, EMA, PMDA and PICS. Our growing team of experts provide custom-made flexible yet robust Quality and CMC systems and lead their implementation in support of clients’ clinical and commercial programs from pre-IND to post-launch. JADE Biomedical contract testing services offer a complete range of analytical testing services suitable for global regulatory filings in our state of the art, global cGMP compliant labs. Our expertise covers all therapeutics platforms including monoclonal antibodies, Antibody-drug-conjugates, cell and gene therapies. To learn more about JADE and for current open positions, visit http://JADE.bio/

View source version on businesswire.com: https://www.businesswire.com/news/home/20210114005108/en/

FAQ

What is the significance of Charles River's partnership with JADE Biomedical?

The partnership expands Charles River's biologics testing capabilities and addresses the increasing demand for cell and gene therapies.

When will the new facility for JADE Biomedical open?

The new facility is expected to come online later this year.

How does the partnership benefit clients in the biopharmaceutical industry?

It combines the expertise of both firms to navigate the complex regulatory environment, providing reliable services to clients of all sizes.

What services will the new facility offer?

The facility will offer GMP and Good Laboratory Practice (GLP) services to support clients' growing needs.

What company is involved in this partnership with CRL?

The partnership involves JADE Biomedical, which specializes in quality management services for the biopharmaceutical industry.