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28
2020 - 02 - 28
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MabPlex International, LTD. has a construction area of 40000m2 and a land area of 28 acres. After phaseⅡproject completed by 2018, the new antibody production lines will have 12 2000L single-use bioreactors and corresponding purification and filling equipment. The ADC production line will have the largest facility (150L conjugation volume) in Asia. These can meet our customers’ need for Phase Ⅲ clinical studies and commercial production. Mabplex provides one-step and high-quality CRO/CMO solutions for biologics to our global clients from R&D to production and drug registration. Supported by our large-scale protein expression and purification techniques and our ADC platform, we not only help our clients accelerate marketing approval by shortening R&D cycles and reducing R&D costs, but also support their marketing needs by consistently delivering large volume and high quality batches at competitive prices. MabPlex’s quality systems strictly follow GMP requirements by USA/EU/Chinese regulatory authorities. Our antibody CMO services can meet our customers’ need for IND filing and PhaseⅠ-Ⅲ clinical studies in USA,EU,AND China.
29
2020 - 03 - 11
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SOTIO is an international biotechnology company leading the efforts of its strategic investor PPF Group to build a diverse pharma company specializing in oncology. SOTIO pursues its goal through in-house research and clinical development, collaboration with external partners, in-licensing deals, investments and acquisitions. The company is developing new therapies focusing on the treatment of cancer and autoimmune diseases. The most advanced project in the SOTIO development portfolio is based on its proprietary DCVAC platform – an active cellular immunotherapy (ACI) on the basis of dendritic cells. SOTIO is testing safety and efficacy of its DCVAC products in multiple Phase I to Phase III clinical trials in oncology indications. SOTIO has a geographic presence in Europe, the United States, China and Russia, enabling a global approach to clinical development. The GMP-certified cell therapy manufacturing facility in Prague, one of the largest of its kind in Europe, can manufacture and supply cellular immunotherapy treatment for clinical development in both Europe and the United States. In Beijing, SOTIO manufactures its products in its GMP-compliant cell therapy manufacturing facility built in 2014 for joint research projects and clinical trials conducted by leading hospitals in China.
30
2020 - 03 - 04
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Nucleus Network is Australia’s largest and only global multi-site dedicated phase I clinical research organisation with phase I facilities located in Melbourne (80 beds), Brisbane (62 beds) and  Minnesota (52 beds).  The phase I units in Australia are strategically co-located within the Alfred Hospital in Melbourne (approx. 800 bed tertiary teaching hospital) and within the Royal Brisbane and Women’s Hospital (approx. 900 bed tertiary teaching hospital) in Brisbane. This combination also provides Nucleus Network with access to a combined population of 7.5 million people within Australia alone. Nucleus Network have extensive experience in the conduct of early phase study designs in healthy volunteers and patient populations eg. FIH SAD and MAD, drug interaction, food effect, bioequivalence, crossover, TQTc, ethnopharmacology, etc. Established in 2004, Nucleus Network has conducted over 750 phase I clinical trials, with 90% of clients being overseas (primarily the USA) pharmaceutical and biotech companies. Approximately 70 phase I studies are conducted annually per year at Nucleus with about 30 of these being true first-in-human studies. Nucleus has extensive experience with both biologics and small molecule products across most therapeutic areas.
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