By Patrick Wingrove
作者Patrick Wingrove
Oct 4 (Reuters) - One of the Largest Contract Drug Manufacturing Plants in the U.S. Owned by Thermo Fisher Scientific Tmo.n Over the Past 10 Years Has Repeatedly Breached Rules Meant to Ensure Drugs Are Free of Contamination, FDA Documents Show, Including Twice This Year.
Oct 4 (Reuters) - One of the Largest Contract Drug Manufacturing Plants in the U.S. Owned by Thermo Fisher Scientific Tmo.n Over the Past 10 Years Has Repeatedly Breached Rules Meant to Ensure Drugs Are Free of Contamination, FDA Documents Show, Including Twice This Year.
The Most Recent U.S. Food and Drug Administration Inspection of Thermo Fisher's Greenville Plant in May Identified Manufacturing Issues for the Respiratory Syncytial Virus Drug Beyfortus, a Preventive Antibody Therapy From AstraZeneca Azn.l and Sanofi Sasy.pa for Infants and Toddlers.
賽默飛世爾五月美國食品藥品監管局對格林威爾工廠進行的最新檢查發現製造問題，用於阿斯利康製造的呼吸道合胞病毒藥物貝福特斯，是預防性抗體療法 Azn.l 和賽諾菲安萬特 Merck KGaA 供嬰兒和幼兒使用。
The Issues Were Resolved to the FDA's Satisfaction, the FDA and Sanofi Said. There Is No Evidence That These Manufacturing Issues Have Resulted in Harm to Patients.
問題已得到美國食品藥品監管局和賽諾菲的滿意解決。沒有證據表明這些製造問題導致患者受到傷害。
The 1.7 Million Square Foot Plant Makes Around 40 Different Medicines, According to the FDA's National Drugs Directory, Including Life Saving Hospital-Administered and Pharmacy Drugs and Novo Nordisk's Novob.co Weight-Loss Medicine Wegovy. Thermo Fisher Bought the Plant in 2017 With Its Acquisition of Contract Manufacturer Patheon.
這個佔地170萬平方英尺的工廠按照美國食品藥品監管局的國家藥物目錄生產約40種不同的藥物，包括可以挽救生命的醫院用藥和藥房用藥，以及諾和諾德的 元件 Novob.co 賽默飛世爾在2017年收購代工廠商Patheon時收購了該工廠。減肥藥物Wegovy。
Growth in Obesity Medicines and Complex Biologic Therapies Is Fueling Demand for U.S. Contract Manufacturers Like Thermo Fisher. but Two Manufacturing Experts Say the Plant's 10-Year Audit Record Gives Them Reason to Be Concerned About the Company's Approach to Quality Control.
肥胖藥物和複雜生物療法的增長推動了對美國代工廠商（如賽默飛世爾）的需求。但兩位製造業專家表示，該工廠過去10年的審計記錄讓他們對公司的質量控制方法感到擔憂。
"There Are Multiple Issues With the Culture of the Organization. They Are Not Looking at the Long Term and Have a Fix-When-Caught Mentality Versus a Culture of Prevention," Said David Talmage, Vice President of Education at the Parenteral Drug Association, Which Provides Training on Best Practices for Sterile Manufacturing.
「該組織的企業文化存在多個問題。他們只注重短期利益，採取被抓了才解決的心態，而不是預防爲主的文化，」孢子藥學協會教育副主席大衛·塔爾萊奇（David Talmage）說。該協會爲無菌製造提供最佳實踐培訓。
The FDA's Inspection of the Beyfortus Production Line Found That Required Manufacturing Processes Fell Short in Areas Such as Ensuring Some Equipment Was Sufficiently Sterilized, According to a Report Obtained by Reuters Through a Freedom of Information Act (Foia) Request.
根據《路透社》通過《信息自由法》（Foia）獲得的報告，FDA對Beyfortus生產線的檢查發現，一些必需的製造流程存在問題，比如確保某些設備被充分滅菌。
A Spokesperson for Sanofi, Which Markets Beyfortus in the U.S. Where It Was Approved Last Year, Said the FDA's Findings Were All Addressed and Subsequently Reviewed by the Regulator. the FDA Approved the Beyfortus Doses Before They Left the Plant for Sale, the Spokesperson Said.
賽諾菲在美國市場銷售Beyfortus，該藥品去年獲得批准。一位代表稱，FDA的發現已得到處理，並得到監管機構的複審。代表表示，FDA在藥品離開工廠銷售前已批准Beyfortus劑量。
Sandy Pound, Chief Communications Officer at Thermo Fisher, Said the Company Participates in More Than 1,000 Regulator and Customer Inspections Every Year and Takes Regulator Observations Seriously. She Did Not Comment on the Specifics of the FDA Audit.
賽默飛世爾首席通信官桑迪·龐德表示，公司每年參與超過1,000次監管和客戶檢查，並認真對待監管機構的觀察結果。她未對FDA審計的具體內容置評。
FDA Report
FDA報告
the FDA Report Noted 17 Shortfalls During the Beyfortus Audit Including Inadequate Visual Inspections for Any Particulate Matter Floating in Injectable Drugs and Problems With How Staff Handled Sterile Components.
FDA報告指出，在Beyfortus審計中存在17個短板，包括對注射藥物中任何懸浮顆粒的視覺檢查不足以及工作人員處理無菌元件存在問題。
One Issue Identified Was Thermo Fisher Had Not Provided the Studies Backing up How It Measured and Set Thresholds for Bubbles That Can Occur in Injectable Medicine. Such Bubbles Can Cause Deadly Blood Blockages in Veins or Arteries.
賽默飛世爾未提供支持其如何測量和設定可以發生在注射藥物中的氣泡閾值的研究是被識別出的一個問題。這種氣泡可能導致靜脈或動脈中產生致命性血液阻塞。
The FDA Said in a Statement That It Had Audited the Plant for Cause Related to Certain FDA Approved Products at the Site and Did Not Take or Recommend Regulatory or Enforcement Action, Saying It Was Not Warranted at This Time.
FDA在一份聲明中表示，已對該地點有關某些FDA批准產品的原因進行了審計，並未採取或建議監管或執法行動，稱這種行動目前不合適。
Most Concerns Raised in FDA Manufacturing Audits Are Solved, as This One Was, Through Agreement With the Company. the FDA Can Take Action When Companies Are Uncooperative or Do Not Make Corrections Fast Enough or to Its Satisfaction.
大多數FDA製造行業審計中提出的問題，就像這個問題一樣，都通過與公司達成協議得到解決。當公司不合作或未能迅速或滿足其要求做出更正時，FDA可以採取行動。
The Agency Said the Manufacturer Had Provided Information on Several Matters Including Control of Bubble Size and Information on Allowable Bubble Size From a Safety Standpoint. the FDA Added That the Facility Had "Adequately Addressed Its Concerns."
該機構表示，製造商已就多個問題提供了信息，包括氣泡大小的控制以及從安全角度允許的氣泡大小的信息。FDA補充說，該設施已「充分解決其關切」。
The FDA Did Not Comment When Asked if Patients Had Been Harmed as a Result of the Lapses.
FDA在被問及患者是否因疏忽而受到傷害時未作評論。
the Medicines Found to Be at Issue in Five Other FDA Audits From 2014 Through February This Year, Were Not Identified in Regulatory Reports Obtained by Reuters. It Has Inspected the Plant at Least 10 Times in the Past 10 Years.
在2014年至今年二月的五次其他FDA審計中發現有關的藥品，在路透社獲得的監管報告中未被識別出。過去十年中至少已對該工廠進行了十次檢查。
The FDA Conducts Thousands of Audits per Year but Time Between Visits to a Plant Varies. It Does Prioritize Plants With Sterile Manufacturing Operations Such as This One.
FDA每年進行數千次審計，但對工廠的訪問間隔時間不同。它會優先考慮具有類似這種無菌製造操作的工廠。
Three Experts Who Reviewed the FDA Documents Said They Were Concerned That Staff Had Not Followed Procedures to Prevent Microbial Contamination, Including Sufficiently Sterilizing the Equipment Used to Seal Drugs and Prevent Leakage.
審閱FDA文件的三名專家表示，他們擔心工作人員未遵守防止微生物污染的程序，包括對用於密封藥物和防止泄漏的設備進行充分滅菌。
Steven Lynn, a Former Head of the FDA's Office of Manufacturing and Product Quality Who Is Now a Regulatory Compliance Consultant, Said the Problems With Thermo Fisher's Checks for Bubble Size Was One of the More Troubling Findings.
前FDA製造與產品質量辦公室主管、現爲監管合規顧問的Steven Lynn表示，賽默飛世爾對氣泡大小的檢測問題是其中比較令人不安的發現之一。
Vaccines, Too
疫苗也是
the FDA First Inspected the Plant This Year in February, According to a Separate Report Obtained by Reuters Through Foia, Targeting Covid and Flu Vaccines, Which Are Given in the Fall When Respiratory Diseases Circulate.
根據路透社通過Foia獲得的另一份報告顯示，FDA今年2月首次視察了該工廠，重點檢查了在秋季呼吸道疾病流行時接種的COVID和流感疫苗。
the Regulator Returned in May With the Aim of Auditing Production of Beyfortus, Moderna's Mrna.o Covid-19 Vaccine, and Two Flu Vaccines Made by Australia's CSL Csl.ax, According to a Source Familiar With the Matter Who Was Not Authorized to Speak.
監管機構於5月再次回訪，目的是審核Beyfortus（Moderna的COVID-19疫苗）以及澳大利亞CSL製造的兩款流感疫苗的生產。 mRNA.o 澳大利亞的CSL製造的兩款流感疫苗和Moderna的COVID-19疫苗 CSL.ax根據知情人士透露，未經授權發表言論。
Moderna and CSL Both Said They Were Not Manufacturing Vaccines at That Plant During Either FDA Visit.
Moderna和CSL均表示，在FDA的任何訪問期間都未在該工廠製造疫苗。
Thermo Fisher's Greenville Plant Received $49 Million From the U.S. Department of Defense in 2020 to Help Make Covid Vaccines and Is One of the Latest Government-Funded Factories Found to Have Fallen Short of FDA Manufacturing Standards.
2020年，賽默飛世爾的格林維爾工廠從美國國防部獲得了4900萬美元的資助，用於生產新冠疫苗，是最新發現不符合FDA製造標準的政府資助工廠之一。 未達到FDA製造標準。.
Thermo Fisher's Manufacturing Business, Which Operates as Patheon and Includes More Than 60 Plants in 24 Countries, Makes up Around $8 Billion, or 19%, of Its $42.8 Billion Annual Revenue.
賽默飛世爾的製造業務，即帕西恩，包括24個國家的60多個工廠，在其428億美元年營業收入中佔據了約80億美元，即19%。
Thermo Fisher Competes With Contract Manufacturing Firms Lonza Lonn.s and Catalent Ctlt.n, Which Has Agreed to Be Bought by Novo Nordisk.
賽默飛世爾與代工廠商龍沙展開競爭。 Lonn.s 和catalent Ctlt.n，已同意被Novo Nordisk收購。
"Contract Manufacturing Will Likely Continue to Be an Above Market Growth Driver for Thermo (Partly) Because of the Underlying Market Demand," Said Deutsche Bank Analyst Justin Bowers.
「代工製造業很可能會繼續成爲賽默飛世爾的市場增長驅動因素，部分是因爲市場的潛在需求，」德意志銀行分析師Justin Bowers說。
(Reporting by Patrick Wingrove in New York; Additional Reporting by Maggie Fick in London; Editing by Caroline Humer and Anna Driver)
（紐約Patrick Wingrove報道；倫敦Maggie Fick進一步報道；Caroline Humer和Anna Driver編輯）