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Japanese media reports Daehan New Pharm's entry into the cell culture media business for biopharmaceutical research and production
2013.02.06
--- Original ---

2013年1月18日

報道各位

株式社細胞科究所

 

韓「大韓新株式社」との細胞培養液事業にする業務提携の

お知らせ

 

　株式社細胞科究所（以下CSTI、本社：仙台市葉、代表

取締役社長：佐藤　威）は自社開した抗ワクチン等のバ

イ

オ品生産用の無血培養液の製造を韓で行うために、大韓新

株式社（以下DHNP、 本社：韓ソウル市、代表理事：裵　建

佑（Bae Kun-Woo））と細胞培養液の製造販にして業務提携を

行いましたのでお知らせ致します。

　CSTIは自社で製造したワクチン生産用の完全合成無血培養液を

2010年から韓のワクチンメカに供給しておりましたが、今後

予測される韓でのワクチンやバイオシミラの生産量大に

伴う細胞培養液の需要加に備えて、韓での生産点を探して

おりました。このたび、DHNPと業務提携を行い、バイオ品生産

用と究開用細胞培養液の製造販を共同で進める事になりまし

た。

　培養液生産設備は、京畿道華城市の工業地にあるDHNPの

品工場に新規に設します。バイオ生産用細胞培養液の需要

はの粉末培地から液培養液での供給に化していることか

ら、新工場では主に液培養液の生産を行います。生産用クリンル

ム超純水製造設備その他の調合設備はDHNPが設置、製品の製

造

と品質管理技術びに培養液原料はCSTIから提供します。初の生

産量は一日たり２千リットル、月産４万リットルの生産を目標と

しております。

　生産販は2013年下期から開始する計で、に生産設備の設計

に入っております。製品は主に韓のワクチンメカや抗

品メカに供給し、さらに各製メカのオリジナル培養液

の受託生産にもする計です。

　CSTIが開し、DHNPで製造する予定のバイオ品生産用の完

全合成無血培養液には、ワクチン生産用が２種類、抗生産

用が１種類、遺子組換え蛋白質生産用が１種類、合計４種類の完

全合成無血培養液があります。これらの培養液はウイルスワクチ

ン、抗、組換え蛋白質の生産能力が高く、また培養液に由する

共蛋白の混入がほとんど無いため、生産した原の品質と性能の

管理が容易になり、生産コストの大幅な削減が期待できます。

　弊社はに中東省珠海市に合弁企業を設立し、2013年初頭か

らの販を目標に細胞療用無血培養液の試生産を進めており

ます。今回、DHNPと業務提携して弊社が開したバイオ生産用

の完全合成無血培養液を韓で生産する事により、東アジア地

域でのCSTIブランドの細胞培養液供給制が整うことになります。

 

【『完全合成無血培養液』のメリット】

① 人や異種動物由成分を全く含まず、化構造の明らかな合成品

のみで構成されているため、ウイルスなどの病原や異種動物由

成分による汚染を回避できます。

② 培養液原料全ての品質と性能管理が可能になり、より安全で安定

した性能の培養液の供給が可能になります。

③ 生産された抗やワクチンの精製工程が簡略化でき、より短い製

造工程で原の生産が可能になります。

 

【培養液とは】

　を構成する組織や細胞を外に取り出し、プラスチックやガラ

ス製の容器の中で殖加工するために不可欠な養液。アミノ酸

や

ビタミン、ミネラル成分等４０７０種類の成分を含有する。

　の培養液は細胞を殖させるためにウシ血やヒト血など

の生由成分を５２０％の濃度に添加する必要があったが、

究開が進み、血の添加を必要としない『無血培地』が開さ

れた。最近ではバイオ品の製造や細胞療の進展に伴いより安

全性の高い『完全合成無血培養液』の要望がえている。

＊ 『無血培養液』

　の古典的培養液を改良し、血液中のタンパク質、遺子組換

タンパク質、動物組織から抽出された細胞成長因子などをあらかじ

め添加した細胞培養液。使用時に新たに血や組織抽出液を添加す

る必要が無く、な細胞を殖させることが可能な培養液。しか

し、血液タンパク質などの生由成分を含むためウイルスや異種

タンパク質などの迷入因子を否定できない。現在市販されている無

血培養液は血液由のアルブミンやトランスフェリンなどの血

タンパク質を多量に含む製品が多い。

＊『完全合成無血培養液』

　培養液の全成分が化構造の明らかな物質のみで構成され、血

タンパク質や組織抽出タンパク質など動物由物質を含まない細胞

培養液。遺子組換え技術により製造され、９９％以上の純度を持

つ生理活性タンパク質は原料として使用できる。原材料の製造過

程、品質、純度などをより密に管理することが可能なため培養液

の性能と品質がさらに安定する。

 

 

【企業】

株式社細胞科究所（CSTI: Cell Science & Technology 

Institute, Inc. ）

設立：　2001年　

所在地：　仙台市葉

資本金：　28,750万円

代表取締役：　佐藤　威（さとうたけし）

事業容：　ヒトや動物用の高性能な細胞培養液の開、製造販

および細胞培養の技術支援

URL:     www.cstimedia.com

 

 

大韓新株式社（DHNP: Dae Han New Pharm Co. Ltd. ）

設立：　1984年

所在地：　韓ソウル市

資本金：　630万US$

代表理事：　裵　建佑（Bae Kun-Woo）

事業容：　ジェネリック品健康補助食品動物用品の製

造販

URL:     www.dhnp.co.kr

 

【本件にする問い合わせ先】

株式社細胞科究所　技術開課

仙台市葉西花苑１１６１６

-------------------------------------------------------------
 

--- Translation ---


January 18, 2013


Cell Science & Technology Institute, Inc. (CSTI)


Announcement of Business Partnership with Daehan New Pharm Co., Ltd. on Cell Culture Media Manufacturing in Korea


Cell Science & Technology Institute, Inc. (Head Office: Aoba-ku, Sendai; President: Takeshi Sato) announces that it has entered into a business partnership with Daehan New Pharm Co., Ltd. (Head Office: Seoul; CEO: Bae Kun-Woo) regarding the manufacturing and sale of cell culture media in Korea. This collaboration aims to produce CSTI’s serum-free culture media for biopharmaceutical production, such as antibody drugs and vaccines, within Korea.


Since 2010, CSTI has been supplying fully synthetic serum-free culture media for vaccine production to Korean manufacturers. However, in anticipation of growing demand for vaccine and biosimilar production in Korea, CSTI has sought a local production base and has now partnered with DHNP for the joint manufacturing and marketing of cell culture media for biopharmaceutical production and research purposes.


A new culture media production facility will be added to DHNP’s pharmaceutical plant located in Hwaseong, Gyeonggi Province. As demand shifts from powdered to liquid media, the new facility will focus mainly on liquid culture media production. DHNP will provide production infrastructure, including clean rooms and ultrapure water systems, while CSTI will supply manufacturing and quality control technologies along with the proprietary culture media formulations. Initial production capacity is targeted at 2,000 liters per day and 40,000 liters per month.


Production and sales are scheduled to begin in the latter half of 2013, with facility design already underway. The culture media will be supplied primarily to domestic vaccine and antibody drug manufacturers, and CSTI and DHNP plan to accommodate contract manufacturing of proprietary culture media for these pharmaceutical companies.


CSTI’s fully synthetic serum-free culture media to be produced by DHNP include four formulations: two for vaccine production, one for antibody production, and one for recombinant protein production. These media offer excellent production efficiency for viral vaccines, antibodies, and recombinant proteins, with nearly no contamination from animal-derived proteins, thereby simplifying quality control and significantly reducing production costs.


CSTI has also established a joint venture in Zhuhai, Guangdong Province, China, to begin pilot-scale production of serum-free cell culture media for cell therapy applications in early 2013. Through this partnership with DHNP, CSTI now secures a production and supply network for its brand of cell culture media throughout East Asia.


Advantages of “Fully Synthetic Serum-Free Culture Media”


Contains no components derived from humans or animals; composed only of chemically defined synthetic substances, preventing contamination by viruses or animal proteins.


Enables full quality and performance control of every component, ensuring safer and more consistent culture media.


Simplifies purification processes for antibodies and vaccines, allowing shorter manufacturing times and reduced production costs.


About Cell Science & Technology Institute, Inc. (CSTI)


Founded: 2001


Location: Aoba-ku, Sendai, Japan


Capital: 2.875 billion yen


President: Takeshi Sato


Business: Development, manufacturing, and sales of advanced cell culture media for human and animal use; cell culture technology support


Website: www.cstimedia.com


About Daehan New Pharm Co., Ltd. (DHNP)


Founded: 1984


Location: Seoul, Korea


Capital: USD 6.3 million


CEO: Bae Kun-Woo


Business: Manufacturing and sales of generic pharmaceuticals, health supplements, and veterinary medicines


Website: www.dhnp.co.kr


Contact for Inquiries:

Cell Science & Technology Institute, Inc.

Technology Development Department

1-16-16 Nishihanazono, Aoba-ku, Sendai, Japan
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