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【drug-news】Genzyme召回免疫抑制剂Thymoglobulin（即复
By SUZANNE SATALINE
April 11, 2008
Genzyme Corp. voluntarily recalled more than 100,000 vials of Thymoglobulin, a drug used during kidney transplants, in what marks another manufacturing problem for the biotechnology company.
The Food and Drug Administration said the batches of Thymoglobulin, when liquefied, appeared to be cloudier than the form approved by the agency. The drug should only be slightly cloudy when liquid is added, the agency said.
Bo Piela, a spokesman for Genzyme, of Cambridge, Mass., said there were no safety threats or efficacy issues involving the recalled vials. The product was manufactured in the first half of 2007, he added.
Thymoglobulin is a freeze-dried product made from rabbit proteins administered by injection to patients undergoing kidney transplants. The drug is intended to prevent a patient from rejecting the transplanted organ. Sales of Thymoglobulin reached $166 million in 2007.
In September, the FDA issued a warning letter saying the company had violated the agency's manufacturing rules at a Lyon, France, plant making Thymoglobulin. The warning letter listed violations that had occurred on several occasions and noted that the company's investigations into adverse events were "inadequate."
The recalled drug was made at the same factory in France, said Mr. Piela. He said the company has been working with the FDA to address the manufacturing issues and Genzyme had uncovered the latest problem.
The FDA directed customers to immediately discontinue use of the drugs from the recalled lots and to return the vials to Genzyme. The company said most of the product has been consumed.
In 4 p.m. composite trading on the Nasdaq Stock Market, Genzyme shares were up $1.80, or 2.5%, to $74.70. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 由于生物技术公司的另一项制造工艺问题，Genzyme公司自愿召回100000瓶复宁(含兔抗人胸腺细胞免疫球蛋白，抗排斥反应药），该药物被用于肾移植。
食品与药品管理局（FDA）声明：与以往FDA所认可的工艺相比，这批复宁药在液化过程中出现了更多的云雾状现象。
Genzyme公司的发言人马萨州剑桥大学的 Bo Piela说，这批被召回的药物并没有安全危害和效能问题。
复宁是一种用于肾移植病人的兔抗人蛋白冷冻干燥制品，该药具有抗移植排斥作用。2007年复宁的销售额达到166,000,000美元。
9月，FDA发布一封警告信，该信指出Genzyme公司在法国Lyon的一家复宁制造工厂违反了FDA的制作规则。这封警告信列出了Genzyme已发生多次的违规事件，并指出对Genzyme公司的违规事件的调查仍不很充分。
Mr. Piela称这批被召回的药物法国同一家公司生产，并说这家公司一直与FDA协作，向他们提供产品工艺，Genzyme已经公布了最新的问题。
FDA呼吁消费者立刻停止使用该批回收药物，并将药水瓶交还给Genzyme公司。公司说大多数产品已经使用。
下午4点，Nasdaq 股票指数，Genzyme公司股份上升$1.80, or 2.5%至 $74.70波动。 Thymoglobulin 这个药物是即复宁，不是复宁。 有个编译的小问题
Thymoglobulin is a freeze-dried product made from rabbit proteins administered by injection to patients undergoing kidney transplants.
即复宁是一种兔源抗体冻干制剂，用于治疗肾移植病人的抗排异反应
关于文中提到的another manufacturing problem for the biotechnology company，实际上上因为去年十月份Genzyme公司位于法国里昂的这家药品生产基地就因类似的生产事件被FDA警告。
以下文章是当时的一篇报道
Genzyme gets slapped on the wrist by FDA
Emilie Reymond
04-Oct-2007 - The US Food and Drug Administration (FDA) has sent a letter to Genzyme to warn it about manufacturing issues at its biomanufacturing facility in Lyon, France.
In the letter, dated 19 September but made public on Tuesday, the regulator said that during an inspection in June inspectors found "significant deviations" from current good manufacturing practices (cGMP) in the production of Thymoglobulin (anti-thymocyte globulin [rabbit]), an antibody-based drug used in kidney transplant patients.
According to the letter, Massachusetts-based Genzyme had issues with its purified water system and quality control unit at the biologics facility located in Marcy L'Etoile in Lyon, which could lead to impurities in the product if the company did not take action.
The FDA letter follows a Form 483 issued to Genzyme in June which described the safety problems found during the manufacture of Thymoglobulina bulk lots that are used to formulate the drug.
Genzyme responded to inspection's observations but the FDA said the response "did not provide sufficient detail to fully assess the adequacy of the corrective actions".
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作者:admin@医学,生命科学 2010-11-12 17:11
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