Jade Biomedical and Bio-Pacific Laboratory – 3 Years and Growing

Suzhou, China – May 15th, 2020 – JADE Biomedical LTD, a leader in end-to-end biomedical Quality Management Services based in China, celebrated its 3rd Anniversary recently, while welcoming Edward Balbirnie, PhD, as Vice President of Quality Assurance, with overall responsibility for strategy and execution of internal and client Quality Assurance functions.

“We are thrilled to have Dr Balbirnie bringing over 30 years of international Senior Management level experience in the Biotech and Biopharma industries to JADE,” said Dr Claudia Lin, Founder and CEO of JADE Biomedical and its fully owned subsidiary, Shanghai Bio-Pacific Laboratories. “Edward has strong current Quality and technical expertise, having worked in the areas of cell therapy, stem cells, gene therapy, monoclonal antibodies, biosimilars, transgenic proteins, antibody-drug conjugates and immunodiagnostics. Along with our COO David Kapitula, Dr Balbirnie will strengthen the JADE executive team in broadening the breadth and coverage of our Quality services to our growing list of Chinese and global client bases.”

A PhD from Dublin, Ireland, and a European Qualified Person (QP), Dr Balbirnie has over 20 years of experience in biopharmaceutical clinical development of several biopharmaceutical product candidates. He has developed Quality systems to support clinical development to commercial stages and has extensive experience of CMC and regulatory requirements during product development processes.

Dr. Balbirnie founded Pomorskie Quality Services, a Polish Quality and Regulatory consulting company with clients in the biopharmaceutical sector in Europe, such as Novartis and in Asia. Most recently, he held senior management positions in Quality and CMC at Gan & Lee Pharmaceuticals in China and Gamamabs Pharma in France. He was Director of Quality Assurance at Elan Drug Technologies in Ireland and Director of Quality Operations at IDM in France, in addition to senior management positions in Biomanufacturing at Polpharma Biologics in Poland and at LFB Biotechnologies in France.

Jade Biomedical and Bio-Pacific Laboratory - 3 Years and Growing

Dr. Balbirnie

“I am very excited to join JADE Biomedical at this stage of their development,” noted Edward Balbirnie. “I look forward to supporting existing and future JADE clients through their clinical development programs to product launch, from Quality Management, CMC and testing perspectives. My QP status will directly benefit those clients whose products are directed towards the European market.”

About JADE Biomedical

JADE Biomedical is a pioneering Contract Quality Organization (Bio-CQO^TM), founded in May 2017 in Suzhou, China. Its fully owned subsidiary Bio-Pacific Laboratories was founded a year later in Shanghai to provide biomedical product safety and other quality control testing under global cGMP-Compliant conditions for GMP product manufacturing and global regulatory authority submissions.

JADE founder and CEO, Claudia Qiao Lin, went to Fudan University before going abroad to the US where she accomplished her PhD from University of California at Berkeley in cell and molecular biology of cancer. Dr Lin did her post-doctoral research in Howard Hughes Medical Institute, UCLA and Lawrence Berkeley National Laboratories in California before starting a successful career in the biopharmaceutical industry in the US. Prior to founding JADE, Dr Lin had 20 years of experience in biopharmaceutical R&D and product development with positions at Exelixis, Genentech, ROCHE, and Bayer Healthcare. She and her teams were involved in a number of blockbuster product launches as well as industry leading quality management initiatives and GMP quality operations at global scales. After a successful track record as a seasoned Quality leader in leading global biopharmaceutical MNCs, Dr Lin returned to China in 2015 to lead quality and compliance for a top Chinese biopharmaceutical company, and has since established herself as a reputable Quality management leader and entrepreneur in China for global product development.

JADE Biomedical was founded upon the premise of solving one of the bottlenecks of biomedical product realization, especially in China; that is, the lack of CMC, especially GMP quality leadership and management experiences in the fast growing biopharmaceutical industry. So far, JADE has provided CQO services to over 20 clients, both Chinese and global companies including quality systems, regulatory inspection (PAI) preparation, product control strategy, IND and BLA filings, facility design and C&Q, cold chain storage etc. Product coverage ranged from monoclonal antibodies and their derivatives, cell and gene therapies etc. In addition to these, JADE Bio-Pacific Laboratories started its GMP operation in 2019 in Zhangjiang, Shanghai hence completing the end-to-end third party Quality Service supply chain for all biomedical product safety and quality control testing.

CONTACT

For more service information and current open positions, see website: Jade.bio

Contact E-mail:

info@jadebiomedical.com

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