Tuesday, April 26, 2016

永昕/ Biosana Pharma 合作 Xolair生物相似藥 (biosimilar) 張子文當顧問!

永昕啟動生物藥新製程 有機會接氣喘藥訂單2016-04-2510:36 〔記者陳永吉/台北報導〕永昕(4726)今日宣布與合作夥伴荷商Biosana Pharma正式啟動生物藥新製程,若驗證成功未來期望降低生物藥品的開發成本及上市後的單位製造成本,也將縮短生物藥的製程時間及降低生物藥廠房建置的資本支出。永昕表示,日前Biosana Pharma的經營團隊與董事會成員在永昕共同召開Kick-off meeting,以Biosana委託永昕開發的Xolair生物相似藥來進行3C連續式製程驗證Xolair是由羅氏大藥廠(Roche)上市銷售的生物藥,主要適應症是氣喘,2013年全球的銷售額達14億美金,專利在2019年過期,未來BiosanaXolair生物相似藥若成功上市,永昕將優先成為其產品製造廠。 永昕在2004年採用拋棄式製程建置生物藥廠,是國內生物藥廠採用拋棄式製程的先驅廠商,相較傳統不鏽鋼製程的生物藥廠大幅降低生物藥廠建置的資本支出,提高不同產品製程轉換的效率以及降低交叉污染的風險,近年來許多生物藥廠商在建置生物藥廠也都採用拋棄式製程,證明了永昕10年前在生物藥製程上的勇敢創新,多年來累積了許多製程上的技術能量,這次啟動的新製程技術稱為「3C連續式製程(Triple C Technology)」,未來產品製造的單位成本將大幅降低,另外也將使未來生物藥廠建置的空間需求變得更小,資本支出可大幅降低。

Biosana Pharma

Ard Tijsterman, CEO Business and drug development. Wide experience in project and organization consulting in the (bio) pharmaceutical arena. Entrepreneur and business developer with his roots in biopharmaceutical production, EU/US compliance, validation, process development and drug development (RA, CMC, non clinical & early stage clinical). Co-founder and co-owner of a number of companies: Xendo, Tarpon Biosystems and BiosanaPharma. 

Nettie Buitelaar: CBO Seasoned biotechnologist (PhD & MBA), until April 2014 manager of Leiden Bio Science Park. Before this Nettie was active as Xendo Business Management leader, managing director of the Dutch BioPartner program (stimulating entrepreneurship in life sciences), as business analyst for Gilde Investment Management and as research manager in biotechnology research institutes.

Jaap den Engelsman: CFO Highly experienced CFO with a track record at a diversity of international operating companies that are active in the food and biotechnology field. A number of these companies are: Cavitus, DSM Food Specialties and DSM Biologics. Jaap is co-founder of Biosana.

Jaap Wieling: CSO & COO Drug development expert, pharmacologist with 25+ years of international (bio)pharmaceutical development, including non-clinical and early-stage clinical development and biopharmaceutical processing. Has a track record as entrepreneur with executive and research management positions at QPS, Xendo, PRA International, DSM and TNO. University lecturer, conference presenter and scientific paper author for 25+ years on scientific, technical and regulatory topics.

Rob Crombie: Advisor As an experienced business developer and operational officer Rob has built a number of successful antibody drug development companies from start-up phase through M&A to trade sale with deals in excess of $300M (EvoGenix, Arana Therapeutics and Cephalon).

Scientific Advisory Board (SAB)

Dr Tse-wen Chang Dr Chang started his industrial career as VP Research at Centocor in the US. As co-founder of Tanox and founding father and inventor of Xolair (Omalizumab) he has become very well known in the research field on allergic asthma. He has received many international awards for his work on Xolair. Dr Chang has filled in a diversity of research related roles as president of the Development Center of Biotechnology in Taiwan, Professor at Tsing Hua University and currently he is active at the Genomic Research Center in Taipei.

Dr Rene Verdonk Dr Verdonk started his career at Bayer where he fulfilled a number of different international positions in clinical, marketing and business management. Hereafter he worked on product development at Pharming NV and a few years ago he co-founded Prothix with Professor Eric Hack for the development of mAb products in the field of coagulation and inflammation.

 

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