News For The Biologics Industry
Suzhou biosafety lab provides phase II viral clearance studies approved by the U.S. FDA
As the first non-state affiliated biosafety testing laboratory in Asia, our Suzhou testing facility has achieved another major milestone since the start of operation in December 2014. Over the past year this group has completed IND-enabling viral clearance studies under strict compliance with EMA guidelines, provided phase II viral clearance studies approved by the U.S. FDA and successfully passed an audit from the CFDA Shanghai office. As part of our single-source, open-access technology platform, the facility provides viral clearance, cell line characterization and lot release testing services (e.g., assays for the detection of mycoplasma, viruses and other microorganisms) compliant with global regulatory standards.
WuXi Biologics opens GMP cell banking manufacturing suites in Shanghai
Along our effort in building a single-source, open-access technology platform for global biologics development, WuXi Biologics recently completed the construction and validation of a GMP cell banking facility in Shanghai. The facility has already passed two client quality audits since its launch. The facility will continue expanding its capacity through the second quarter and after August a total of five cell banking suites will be fully validated. It is expected that the cell banking capacity will be up to 80 cell banks per year. The cell banking facility works closely with our biosafety lab in Suzhou (less than 2 hour drive from Shanghai) for cell line characterization to further reduce the development timeline and offer a truly simplified supply chain for our global customers.
WuXi Biologics’ Antibody Conjugation Team receives Genentech “Outstanding Achievement Award”
Two project leaders, Dr. Julie Hang and Ms. Rachana Ohri, of Genentech visited the WuXi Biologics’ Biologics Conjugate Development (BCD) department from April 5-8, 2016 and on behalf of their company, issued an “Outstanding Achievement Award” to members of the antibody conjugation project team to honor their contributions to Genentech.
Dr. Julie Hang and Ms. Rachana Ohri highly admired and regarded the achievements that Wuxi Biologics has made in four short years to become a world-recognized protein/antibody CRO company. They praised the antibody conjugation project team whose work demonstrates WuXi Biologics’ capabilities in antibody conjugation platform build-up and that the team has already impressed many departments within Genentech.
WuXi Biologics’ CEO, Dr. Chris Chen, Vice President and Head of BCD, Dr. Jiawen Han and the project team members attended the award ceremony. Dr. Jiawen Han thanked Genentech for their continued and increased support of the bioconjugation team and believed that the team will do their best and make further contributions to future Genentech projects.
WuXi Biologics’ Protein Sciences Team receives Genentech “Outstanding Achievement Award”
Dr. Jiansheng Wu and Ms. Hong Li from Genentech recently visited the WGQ Site and presented an “Outstanding Achievement Award” to the WuXi Biologics’ Protein Sciences department for their great contribution over the past years. Dr. Wu also presented a three-year contribution award to Ms. Zhumei Feng.
Dr. Wu expressed his appreciation for WuXi team’s effort of building multiple high-throughput protein production platforms through heavy investment to support Genentech’s protein drug discovery needs over the past 3 years. He also praised all team members for their dedication and outstanding efforts to provide high-efficiency core services.
Dr. Weichang Zhou, Sr. Vice president of WuXi Biologics, Ms. Jill Cai, Executive Director and all the project team members attended the ceremony. Dr. Zhou thanked Genentech for their continuous support of WuXi Biologics and encouraged the team members to be even more innovative and make further contributions to Genentech’s protein drug discovery programs.
WuXi Biologics congratulates TESARO for Anti-TIM-3 antibody IND submission in the U.S.
Congratulations to our partner TESARO for completing the IND submission for TSR-022 to the U.S. Food and Drug Administration! “We are very pleased to have completed this critical project from DNA to IND in an expedited manner, which manifested our strong value proposition as a global integrated biologics solution provider,” said Dr. Chris Chen, CEO of WuXi Biologics.
“We are pleased to be working with WuXi on our immuno-oncology programs,” said Jeffrey Hanke, Ph.D., Executive Vice President, Research and Development, and Chief Scientific Officer of TESARO. “WuXi’s state-of-the-art, full-service biologics platform enabled us to quickly produce clinical supply of TSR-022 in support of our IND submission.”
“Congratulations to TESARO on this great progress in the important field of immuno-oncology,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec. “We are honored to play a role to support innovative partners like TESARO through WuXi’s integrated, open-access R&D services platform, and we wish the program great clinical success.”
WuXi plans $120 million investment in new integrated biologics solution center to expedite biologics development from ideas to clinic
We are excited to announce that we have started construction of a state-of-the-art integrated biologics solution center at our headquarters in Shanghai. WuXi plans to invest a total of $120 million in this 250,000-square-foot facility, which will accommodate 800 scientists. The facility will provide integrated solutions from ideas to the clinic for biologics discovery, development, and clinical GMP manufacturing on a consolidated campus. With a comprehensive platform integrated from discovery through all aspects of development, customers will benefit from the speed, agility, efficiency, and unsurpassed quality of WuXi’s operations to expedite their global biologics research and development. The facility is expected to be fully operational by 2017. We are very pleased to continue to invest in our biologics capabilities and expand our capacities to support the ambitious plans of our global clients.
Prima BioMed and WuXi Biologics announce first dose of Chinese-manufactured biologic in EU clinical trial
We are thrilled to announce that through our strategic supply partnership with Prima BioMed, Prima’s first-in-class immuno-oncology product candidate IMP321 (LAG-3 Ig fusion protein), manufactured at WuXi’s state-of-the-art cGMP facility in China, has now been dosed in a Phase IIb clinical trial in Belgium. This is the first time a biologic manufactured in China has been released for use in a clinical trial in the EU. This also marks the first patient being dosed in AIPAC (Active Immunotherapy PAClitaxel), Prima’s Phase IIb clinical trial in metastatic breast cancer.
WuXi is also supplying IMP321 to Prima’s TACTI-Mel Phase I melanoma trial currently recruiting in Australia. With the start of this exciting clinical trial for IMP321, in addition to supplying material for other recent Clinical Trial Application filings and approvals by WuXi partners, WuXi Biologics is rapidly becoming a significant contributor to the expedited development of innovative biologics in the EU.
WuXi Biologics congratulates Ambrx and ZMC for successful dosing of a novel antibody-drug conjugate in Australia
Congratulations to our partners Ambrx and Zhejiang Medicine Company (ZMC) for completing dosing of the first patient for ARX788, a novel antibody-drug conjugate (ADC) product candidate for treating breast cancer and gastric cancer in Australia.
As part of the collaboration, WuXi provided comprehensive, integrated services for ARX788 from clones to IND. WuXi successfully scaled up manufacturing processes for the novel toxin and linker, the monoclonal antibody, the ADC drug substance and drug product under cGMP conditions. These activities were all conducted at WuXi’s facilities within a 100 mile radius, eliminating the complex transportation issues often associated with ADC manufacture. This project represents the first site-specific ADC using a non-natural amino acid technology. It also represents the first reported case of large-scale manufacture of such an ADC for clinical applications. The IND for ARX-788 was approved in Australia and New Zealand and the IND application was also accepted by CFDA last month. This project represents one of the first case studies of using the same CMC and preclinical package for simultaneous global filings. We are very pleased to have completed this complicated ADC project within only 20 months, which manifested our strong value proposition of the integrated solution provider.
CANbridge selects WuXi Biologics to manufacture CAN-008 for the China market
We are happy to announce that WuXi Biologics is selected by CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, to manufacture CAN-008 in China, in preparation for a glioblastoma IND submission to the China Food and Drug Administration (CFDA). CAN-008 is a fully human fusion protein that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking the ligand, CAN-008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. This partnership once again demonstrates the enabling power of WuXi’s world-class proprietary biologics platform and our dedication in making life-saving biologics more affordable and available to Chinese patients.