Bioworkshops Suzhou is a biopharmaceutical company with headquarters in Hong Kong which develops first-in-class and best-in-class antibody products for China and the world in collaboration with international partners. We develop and manufacture clinical drug substances and drug products produced by cell culture to international standards. Our Mission is to consistently develop and achieve approval of biologic products faster than anyone else in China through expert application of manufacturing science. The Company has recently acquired a 28,000 sq. meter building and land in Suzhou and is investing over RMB300M in building state-of-the art development and clinical manufacturing facilities in 2019 and will be well on the way towards our goal of obtaining the first IND approval in 2020. 康日百奧（蘇州）是一家總部位于香港的抗體研發(fā)企業(yè)，致力于匯同其國際合作伙伴為中國乃至全球帶來行業(yè)領(lǐng)先和同類之最的新藥產(chǎn)品。我們遵照國際標(biāo)準(zhǔn)開發(fā)基于細(xì)胞培養(yǎng)的生產(chǎn)工藝來進(jìn)行臨床用原液和成品的生產(chǎn)。我們的使命是通過制造科學(xué)的專業(yè)應(yīng)用，比中國其他競爭對手更快速的完成生物制品的開發(fā)及批準(zhǔn)。 我們公司最近在蘇州收購了一棟總建筑面積28000平米的大樓及土地，投資了超過3億元人民幣擬在2019年建成具備先進(jìn)水平的研發(fā)和臨床樣品生產(chǎn)基地并將在2020年實現(xiàn)獲得首個IND批準(zhǔn)的目標(biāo)。 Talented, productive experts 極具才華且成果卓著的專業(yè)團(tuán)隊 The founding members of Bioworkshops are industrial veterans from Australia and China who have been starting-up and leading biologics product development companies and biologics manufacturing organizations all over the world for more than 20 years. In the past five years alone, the founding team has successfully developed over 10 new antibody products for US, Australia, and China markets and have completed successful design, build, and start-up of four biologics development and manufacturing centers: Clinical and commercial production. Inspected for compliance against US-FDA, NMPA, TFDA, and TGA regulations to file CTA/IND and commercial products. We have quickly established a start-up team and are recruiting more expert staff to exceed 150 employees within the coming year. 康日百奧的創(chuàng)始成員是來自澳大利亞和中國的行業(yè)資深人士，在過去20余年的時間里在世界范圍內(nèi)創(chuàng)辦并領(lǐng)導(dǎo)了多個生物制品研發(fā)及生產(chǎn)企業(yè)。僅在過去的五年中，創(chuàng)始團(tuán)隊就成功為美國，澳大利亞和中國市場開發(fā)了10多種新型抗體產(chǎn)品，并同時成功完成了四個生物制品研發(fā)和制造中心的設(shè)計、施工和啟用： 臨床和商業(yè)化生產(chǎn) 通過了美國食品及藥物監(jiān)督管理局，中國藥品監(jiān)督管理局，臺灣衛(wèi)生福利食品藥物管理署和澳洲醫(yī)療用品監(jiān)管局針對新藥臨床申報和藥品商業(yè)化報產(chǎn)的現(xiàn)場檢查 我們已快速的建立起了一支初創(chuàng)團(tuán)隊并將持續(xù)的招募更多的專業(yè)人士加入以期在明天擴展成為一個規(guī)模達(dá)150人的團(tuán)隊。 Management of Quality 質(zhì)量管理 Predictable, excellent performance requires deliberate management of quality with commitment to continuous improvement. Bioworkshops Quality Management System encompasses all business operations with particular focus on pharmaceutical product quality in development and manufacturing to comply with Chinese, European, and American Good Manufacturing Practice. 可預(yù)見且卓越的表現(xiàn)需要深入***的質(zhì)量管理，并致力于在過程中不斷的改進(jìn)?？等瞻賷W的質(zhì)量管理體系貫穿于公司的整個商業(yè)運營過程中，并尤其注重醫(yī)藥產(chǎn)品在研發(fā)和生產(chǎn)過程中的質(zhì)量，以符合中國，歐洲和美國GMP規(guī)范。 Innovative R&D Hub and Productive international-standard facilities 創(chuàng)新型研發(fā)中心和高產(chǎn)能國際標(biāo)準(zhǔn)廠房 Located within in the heart of Suzhou Industrial Park, we are building high-capacity drug discovery, development and manufacturing facilities for Development capacity for 8-12 INDs per year. Clinical drug substance manufacturing to 2,000L. Aseptic filling of liquid product into vials. Best in class bioprocess and analytical performance. 我們位于蘇州工業(yè)園區(qū)的核心區(qū)域，正在建設(shè)大容量的新藥發(fā)現(xiàn)，開發(fā)和生產(chǎn)基地： 建立具備每年開發(fā)8-12個IND項目的能力 2000L臨床用原液生產(chǎn) 無菌水針制劑灌裝 一流的的生物工藝和分析能力 Bioworkshops Founding Values 康日百奧價值觀 We believe that strong culture and alignment of purpose are essential in business. The core principles maintained by Bioworkshops are: Excellence in biologics innovation and development. Strong relationships based on honesty. Sustainability measured by workplace safety, impact on the environment, and longevity in business. Enthusiasm for ambitious goals and creative solutions. Respect for the sustained effort required to achieve ambitious goals in our industry. 我們相信強有力的文化和共同的目標(biāo)對于企業(yè)至關(guān)重要?？等瞻賷W所維系的核心原則是： 卓越的生物制品創(chuàng)新和研發(fā) 牢固的關(guān)系源自誠信 可持續(xù)性通過安全生產(chǎn)，環(huán)境影響和長久永續(xù)的商業(yè)模式來衡量 熱衷于樹立遠(yuǎn)大目標(biāo)并提出創(chuàng)造性解決方案 敬畏那些在本行業(yè)中為了實現(xiàn)宏偉目標(biāo)而持之以恒付出的努力