Through Mab-Venture’s strict adherence to ICH guidelines and global development expertise, they will manufacture these programs in support of global clinical trials.
BioSciencesCorp will commercialize biosimilar programs through partners in India, SAARC, MENA, Turkey, LatAm, Russia, and other territories
Mab-Venture will develop and manufacture multiple biosimilars for global multicenter clinical trials
Shanghai, China and California, USA - BioSciencesCorp, a consultancy and late stage product acqusition company that specializes in biologics with a focus on biosimilars and Mab-Venture, a Shanghai-based biologics CDMO, will collaborate on development and manufacturing of multiple undisclosed biosimilars. Mab-Venture has developed and scaled up multiple biosimilars and filed an IND with the CFDA in 2017 and anticipates filing multiple INDs in 2018. Through Mab-Venture’s strict adherence to ICH guidelines and global development expertise, they will manufacture these programs in support of global clinical trials. BiosciencesCorp., in conjunction with regional partners will conduct clinical trials and commercialize multiple biosimilar programs in India, Latin America, Russia/CIS, and other undisclosed territories. Through decades of experience in global biosimilar development, BiosciencesCorp. will accelerate clinical development of multiple molecules in conjunction with local partners.
Mab-Venture will also retain BiosciencesCorp. to support start up and validation of its “SmartFactory” in Shanghai. BiosciencesCorp. team has been in the areas of design, build, start-up, commissioning, validation and facility commercialization for more than 20 years. Robert Salcedo personally led the development of the Amgen Site in Puerto Rico where he built three facilities; bacterial, mammalian, and fill finish exceeding $1B dollars. Such facilities have been designed and approved by US and EU regulatory agencies. Their role will allow Mab-Venture to develop a low-cost, high efficiency biomanufacturing facility to support global development from China.
“We are excited to work with such an experienced team to accelerate development of programs manufactured by Mab-Venture. We have a deep understanding on how to manufacture and develop a biosimilar for China and major markets such as the U.S., but must rely on regional partners for successful development and commercialization in other territories. With the goal of manufacturing high quality biologics for global commercialization, we anticipate the SmartFactory we are developing in conjunction with Thermo Fisher/Finesse will give us an advantage in efficiency and quality, but Robert and Daniel’s expertise in facility start up will be critical in fast tracking start up and validation”, said George Wang, Founder and CEO of Mab-Venture.
“Biosciences is pleased to partner with Mab-Venture as part of our commercialization efforts in emerging markets. Our excitement stems from the quality conscious DNA that is embedded within Mab-Venture’s management team led by George Wang. Our partnership envisions the usage of their global regulated facility for contract manufacturing services to aid in the rapid commercialization of our rapid growing pipeline. This aligns with the China’s regulatory agencies new guidelines that closely mimics global regulatory agencies. Mab-Venture’s planned footprint and mission to be a global company based in China is very exciting. The team that George has put together comes from the top biotech firms in the world. We are excited to re-unite with them to enable a global regulatory compliant company,” said Robert Salcedo, President of BioSciencesCorp.
About Mab-Venture
Mab-Venture was founded by Dr. George Wang in 2013 and is located in Shanghai Zhangjiang Hi-Tech Park. The company specializes in the CMC development, pre-clinical studies, and regulatory filings for antibodies and recombinant proteins. As an innovative, high-tech enterprise, Mab-Venture has a large number of core technologies and has applied for/received more than 10 patents and is continuing to build an integrated and one-stop platform for biologics drug development from cell line development to commercial manufacturing. Mab-Venture has over 400,000 Sq. Ft. of development and manufacturing space and has partnered with Thermo Fisher to jointly establish Asia-Pacific’s first antibody drug “SmartFactory”, to accelerate the development of biopharmaceuticals. Mab-Venture’s senior management has spent an average of >20 years’ experience in multinational and Chinese biopharma including Amgen, Johnson and Johnson, GSK, and Medimmune. For more information, please visit: www.mab-venture.com.
About BiosciencesCorp.
BioSciencesCorp team have developed numerous molecules from vector to final master cell lines and have designed and built facilities for top 5 global biologics including Amgen and Genentech. The team has also created and sold their own biosimilar company which had developed and filed for USA and EU approval. BioScienceCorp is led by Daniel Chang and Robert Salcedo who have more than 25 years’ experience in biotechnology. BiosciencesCorp. has a deep understanding and real-life experience in running and managing biosimilar development, as well as supporting leading pharmaceutical in their portfolio strategy, manufacturing capacity, regulatory strategy, R & D, and helping companies with FDA remediation plans in support of biosimilar approval.
