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        它們籍籍無名,但在疫苗生產中舉足輕

        它們籍籍無名,但在疫苗生產中舉足輕

        Sy Mukherjee 2021年04月22日
        這些公司到底是何方神圣?

        當新冠病毒這種肆虐全球的傳染病遭遇到錯綜復雜的制藥業商業動態時,情況可能會變得相當棘手。

        僅僅發明一種新的疫苗或治療劑本身就是一個耗時且不可預測的過程,接下來,還需要大規模生產這種新產品,以便將疫苗配送到世界各地的接種點,然后注射到人們的手臂上。

        這時,外包制造商就顯得尤為重要。這些公司的名字可能并非家喻戶曉,但它們正在發揮著舉足輕重的作用——要么直接參與疫苗的生產,要么履行著并非所有制藥商都有能力完成的其他重要功能,比如將新冠疫苗裝入小瓶,從而讓其能夠真正送到患者手中。

        新冠疫情的爆發促使這些外包制造商和與之合作的制藥業合作伙伴形成了一種猶如蜘蛛網般的關系。多位專家對《財富》雜志表示,目前還很難預測這場疫情會如何重塑這些外包公司的盈虧底線和業務戰略,而預判隨著冠狀病毒變異株出現,它們在未來扮演的角色更是難上加難。

        在藥品制造領域里,一些巨頭級企業可能會憑借著它們了解的某種冠狀病毒疫苗技術,最大程度地提升產量;其他企業或許沒有這種能力或訣竅,無法依靠新的疫苗平臺——例如輝瑞和Moderna合作開發的mRNA技術——來創造定制化的生物成分,但仍然有可能助力其他疫苗實現規?;a,例如強生或阿斯利康等公司研發的新冠疫苗。

        此外,由于輝瑞等制藥巨頭專注于利用自身的生產設施生產疫苗,還有一些外包制造商可能不得不在生產非新冠藥物方面扮演更加重要的角色。

        “好消息是,全球有足夠的產能?!被瘜W工程師、制藥業資深人士西蒙·布萊耶說。他目前在致力于改善全球疫苗生產和公平分配的非營利組織PATH擔任化學、制造和控制主管。

        “所以我們看到,可以用于全球生產的制造硬件設施和企業數量,足以滿足龐大的疫苗需求?!?/p>

        在生命科學領域中,從來不缺中間商。行業高管向《財富》雜志透露稱,一旦爆發公共衛生緊急事件,全球競爭對手和行業參與者就必須建立,并且已經達成臨時關系,以確保盡可能多的可用疫苗注入盡可能多的手臂上。美國目前僅有三種獲得緊急授權使用的新冠疫苗,其中強生疫苗最近因為潛在的安全問題而被暫時叫停。

        根據美國疾病控制與預防中心的數據,截至4月13日,全美已經注射了超過1.92億劑疫苗。

        對單個外包制造商來說,未來的情況則要微妙得多。

        這些公司究竟是何方神圣,它們到底是做什么的?

        人們可能很容易認為,制藥商,即所謂的藥品創新公司,是唯一真正參與新療法推出過程的企業,其中包括輝瑞及其合作伙伴BioNTech,以及Moderna等公司。這些公司都利用開創性的mRNA技術贏得了美國首批新冠疫苗的緊急使用授權。

        強生和阿斯利康則利用一種被稱為腺病毒或感冒病毒的東西來制造疫苗,盡管強生使用的是人類腺病毒,而阿斯利康使用的是黑猩猩腺病毒。

        在世界各地,還有數十種冠狀病毒疫苗處于不同的臨床試驗或授權階段,其開發商既有制藥巨頭,也有一些新近崛起的生命科學企業。

        不過,一旦產品得到驗證,許多制藥公司就會依賴外包生產。該領域里瞬息萬變、層出不窮的創新,要求這些外包制造商自身擁有敏銳的科學專業知識,并且愿意在緊急情況下為未經驗證的產品承擔風險。而生產這種初始物質,即構成疫苗等核心產品的生物“原料藥”,絕非易事。

        但是,盡管商業條件不那么理想,這種類型的制造只會越來越多。分析師稱,生物制藥公司往往會將各種藥物的生產環節外包出去,這是一個不斷增長的市場。

        根據Grand View Research發布的報告,到2025年,全球藥品外包合同制造和開發市場將激增至1577億美元——意味著未來七年的年復合增長率高達6.9%。這將讓這些第三方參與者的增長速度超過制藥行業本身。

        新冠疫情如何撼動行業格局

        “新冠疫情已經瓦解了整個制藥業的供應鏈?!盙rand View Research的分析師在最近發布的一份關于新冠疫情對行業影響的報告中寫道?!叭欢?,生物制藥(外包制造商和研究機構)對疫情反應良好,因為此類組織恰恰是供應鏈中斷的受益者?!?/p>

        根據新冠疫苗的具體情況,制藥公司正在基于各自的疫苗技術,探索不同的戰略與外包制造商開展合作。

        例如,輝瑞的疫苗有著非常專業化的要求,特別是在冷鏈方面——它需要采用超低溫儲存和配送。正因如此,這家制藥商主要依靠自己現有的設施來擴大生產規模。

        該公司表示,它擁有大約40家工廠來提升疫苗產量,還有200多家供應商協助分銷。輝瑞已經將其非冠狀病毒藥物的生產承包給外部制造商,以便為自家工廠生產疫苗騰出空間。

        mRNA疫苗需要分解病毒的遺傳密碼和病原體未來的潛在變種。要生產這種疫苗,必須得具備一些機構專有技術。這就是為什么康泰倫特和瑞士制造商龍沙集團等公司,比那些不具備生產mRNA疫苗所需的機構技術或基礎設施的小型外包制造商具有明顯優勢。

        例如,康泰倫特正在支持80多種新冠病毒治療劑和疫苗的規?;a,包括生產Moderna、阿斯利康和強生的疫苗。該公司每年在全球生產7000多種藥品,產量超過700億劑,并與1000多家客戶合作??堤﹤愄仡A計今年將參與80多種疫情相關項目,生產逾10億劑新冠疫苗和治療劑。

        此外,這家年收入30億美元的公司也在安全地將疫苗裝入小瓶(用行業術語來說就是“灌封”)這一關鍵環節中扮演著重要角色。

        目前正在大規模生產Moderna疫苗的龍沙集團,向《財富》雜志引薦了這家規模相對較小的生物技術公司。

        Moderna的首席執行官雷·喬丹表示:“對我們來說,尤其是對mRNA疫苗而言,外包制造商在前期扮演著特別關鍵的角色,以供應商的身份幫助我們完成流程?!鳖H為巧合的是,他此前曾經供職于輝瑞和強生公司。

        “然后就是下游的灌封等環節。一旦藥物研發成功,你就需要把它裝入可用的小瓶。但這個生產流程是我們所不具備的,所以我們完全依靠外包制造商來完成?!?/p>

        這就需要在全球疫情爆發期間進行跨行業合作。

        “我們在灌封不同類型的復雜生物產品,并大規模生產這些產品方面擁有豐富經驗?!笨堤﹤愄氐谋泵郎锊块T總裁邁克·萊利說,“每個產品都有一點點不同,有著自己的敏感性。所以,當我們拿到一款新產品,比如Moderna的mRNA疫苗的時候,我們需要搞清楚它特定的處理要求,以及非常具體、相當復雜的生產流程。但我們有足夠的能力與Moderna通力合作,我們知道如何大幅度提升這種疫苗的生產規模?!?/p>

        其他制造商也各有專長。Emergent BioSolutions正在協助強生和阿斯利康生產疫苗,其生產過程涉及到一些不同于mRNA疫苗的老派技能。順便說一句,該公司的巴爾的摩生產基地最近發生了一起事故,導致數百萬劑新冠疫苗被毀。

        有鑒于此,制藥商或許需要向外包制造商分享一些技術方法,以確保疫苗的安全生產。但這也是讓世界免疫的必要條件。

        這些公司將如何應對冠狀病毒新菌株?

        這一切對未來意味著什么?畢竟,正如我們在新冠病毒身上看到的那樣,病毒會不斷進化。所以企業也必須不斷進化,才能夠迎接瞬息萬變的挑戰。它們能否做到這一點,則是一個更加開放的問題,特別是如果新冠病毒開始變得像流感那樣,需要人們每年打新的加強針才可以獲得抗體的話。

        PATH的布萊耶強調稱,考慮到新冠疫情的性質和不斷演變的技術,現在推測還為時過早。但他和其他多位接受《財富》雜志采訪的專家表示,在新冠病毒問題上,外包制造商未來的成功取決于它們的經驗、現有能力,以及學習新技巧的意愿。

        “擁有這種新型mRNA疫苗生產技能的制造商,其實并不多?!辈既R耶補充說,不那么復雜的新冠疫苗能夠“相對容易地轉移到外包制造商那里生產?!?/p>

        “但找到一家既可以處理初級制造,又能夠處理mRNA疫苗二級制造的外包制造商,則是一件復雜得多的事情?!彼f。

        這就體現出機構記憶的重要性??堤﹤愄氐娜R利對此進行了一番詮釋?!拔覀冊缭趲啄昵熬团cModerna合作,幫助它們開展個性化癌癥疫苗項目,從而對mRNA治療劑有了一定的認知?!彼f,“我們當然看到了這項技術的潛力,也看到了開發產能、知識和能力來支持這類項目的種種好處?!?/p>

        這就是不斷演變的科學和藥物研發的本質,而這種動態在新冠疫情期間發展得更加迅速。包括大型制藥公司和小型生物技術公司在內,各路參與者不僅需要相互分享知識,還必須向它們的外包制造合作伙伴分享專有技術。

        這有可能促使藥品制造領域迎來一場變革:規模較小的合同外包制造組織將專注于生產更加傳統的藥物,而規模更大的制造商則利用更多的資源來幫助對抗這種病毒,并從中學習新知識。(財富中文網)

        譯者:任文科

        當新冠病毒這種肆虐全球的傳染病遭遇到錯綜復雜的制藥業商業動態時,情況可能會變得相當棘手。

        僅僅發明一種新的疫苗或治療劑本身就是一個耗時且不可預測的過程,接下來,還需要大規模生產這種新產品,以便將疫苗配送到世界各地的接種點,然后注射到人們的手臂上。

        這時,外包制造商就顯得尤為重要。這些公司的名字可能并非家喻戶曉,但它們正在發揮著舉足輕重的作用——要么直接參與疫苗的生產,要么履行著并非所有制藥商都有能力完成的其他重要功能,比如將新冠疫苗裝入小瓶,從而讓其能夠真正送到患者手中。

        新冠疫情的爆發促使這些外包制造商和與之合作的制藥業合作伙伴形成了一種猶如蜘蛛網般的關系。多位專家對《財富》雜志表示,目前還很難預測這場疫情會如何重塑這些外包公司的盈虧底線和業務戰略,而預判隨著冠狀病毒變異株出現,它們在未來扮演的角色更是難上加難。

        在藥品制造領域里,一些巨頭級企業可能會憑借著它們了解的某種冠狀病毒疫苗技術,最大程度地提升產量;其他企業或許沒有這種能力或訣竅,無法依靠新的疫苗平臺——例如輝瑞和Moderna合作開發的mRNA技術——來創造定制化的生物成分,但仍然有可能助力其他疫苗實現規?;a,例如強生或阿斯利康等公司研發的新冠疫苗。

        此外,由于輝瑞等制藥巨頭專注于利用自身的生產設施生產疫苗,還有一些外包制造商可能不得不在生產非新冠藥物方面扮演更加重要的角色。

        “好消息是,全球有足夠的產能?!被瘜W工程師、制藥業資深人士西蒙·布萊耶說。他目前在致力于改善全球疫苗生產和公平分配的非營利組織PATH擔任化學、制造和控制主管。

        “所以我們看到,可以用于全球生產的制造硬件設施和企業數量,足以滿足龐大的疫苗需求?!?/p>

        在生命科學領域中,從來不缺中間商。行業高管向《財富》雜志透露稱,一旦爆發公共衛生緊急事件,全球競爭對手和行業參與者就必須建立,并且已經達成臨時關系,以確保盡可能多的可用疫苗注入盡可能多的手臂上。美國目前僅有三種獲得緊急授權使用的新冠疫苗,其中強生疫苗最近因為潛在的安全問題而被暫時叫停。

        根據美國疾病控制與預防中心的數據,截至4月13日,全美已經注射了超過1.92億劑疫苗。

        對單個外包制造商來說,未來的情況則要微妙得多。

        這些公司究竟是何方神圣,它們到底是做什么的?

        人們可能很容易認為,制藥商,即所謂的藥品創新公司,是唯一真正參與新療法推出過程的企業,其中包括輝瑞及其合作伙伴BioNTech,以及Moderna等公司。這些公司都利用開創性的mRNA技術贏得了美國首批新冠疫苗的緊急使用授權。

        強生和阿斯利康則利用一種被稱為腺病毒或感冒病毒的東西來制造疫苗,盡管強生使用的是人類腺病毒,而阿斯利康使用的是黑猩猩腺病毒。

        在世界各地,還有數十種冠狀病毒疫苗處于不同的臨床試驗或授權階段,其開發商既有制藥巨頭,也有一些新近崛起的生命科學企業。

        不過,一旦產品得到驗證,許多制藥公司就會依賴外包生產。該領域里瞬息萬變、層出不窮的創新,要求這些外包制造商自身擁有敏銳的科學專業知識,并且愿意在緊急情況下為未經驗證的產品承擔風險。而生產這種初始物質,即構成疫苗等核心產品的生物“原料藥”,絕非易事。

        但是,盡管商業條件不那么理想,這種類型的制造只會越來越多。分析師稱,生物制藥公司往往會將各種藥物的生產環節外包出去,這是一個不斷增長的市場。

        根據Grand View Research發布的報告,到2025年,全球藥品外包合同制造和開發市場將激增至1577億美元——意味著未來七年的年復合增長率高達6.9%。這將讓這些第三方參與者的增長速度超過制藥行業本身。

        新冠疫情如何撼動行業格局

        “新冠疫情已經瓦解了整個制藥業的供應鏈?!盙rand View Research的分析師在最近發布的一份關于新冠疫情對行業影響的報告中寫道?!叭欢?,生物制藥(外包制造商和研究機構)對疫情反應良好,因為此類組織恰恰是供應鏈中斷的受益者?!?/p>

        根據新冠疫苗的具體情況,制藥公司正在基于各自的疫苗技術,探索不同的戰略與外包制造商開展合作。

        例如,輝瑞的疫苗有著非常專業化的要求,特別是在冷鏈方面——它需要采用超低溫儲存和配送。正因如此,這家制藥商主要依靠自己現有的設施來擴大生產規模。

        該公司表示,它擁有大約40家工廠來提升疫苗產量,還有200多家供應商協助分銷。輝瑞已經將其非冠狀病毒藥物的生產承包給外部制造商,以便為自家工廠生產疫苗騰出空間。

        mRNA疫苗需要分解病毒的遺傳密碼和病原體未來的潛在變種。要生產這種疫苗,必須得具備一些機構專有技術。這就是為什么康泰倫特和瑞士制造商龍沙集團等公司,比那些不具備生產mRNA疫苗所需的機構技術或基礎設施的小型外包制造商具有明顯優勢。

        例如,康泰倫特正在支持80多種新冠病毒治療劑和疫苗的規?;a,包括生產Moderna、阿斯利康和強生的疫苗。該公司每年在全球生產7000多種藥品,產量超過700億劑,并與1000多家客戶合作??堤﹤愄仡A計今年將參與80多種疫情相關項目,生產逾10億劑新冠疫苗和治療劑。

        此外,這家年收入30億美元的公司也在安全地將疫苗裝入小瓶(用行業術語來說就是“灌封”)這一關鍵環節中扮演著重要角色。

        目前正在大規模生產Moderna疫苗的龍沙集團,向《財富》雜志引薦了這家規模相對較小的生物技術公司。

        Moderna的首席執行官雷·喬丹表示:“對我們來說,尤其是對mRNA疫苗而言,外包制造商在前期扮演著特別關鍵的角色,以供應商的身份幫助我們完成流程?!鳖H為巧合的是,他此前曾經供職于輝瑞和強生公司。

        “然后就是下游的灌封等環節。一旦藥物研發成功,你就需要把它裝入可用的小瓶。但這個生產流程是我們所不具備的,所以我們完全依靠外包制造商來完成?!?/p>

        這就需要在全球疫情爆發期間進行跨行業合作。

        “我們在灌封不同類型的復雜生物產品,并大規模生產這些產品方面擁有豐富經驗?!笨堤﹤愄氐谋泵郎锊块T總裁邁克·萊利說,“每個產品都有一點點不同,有著自己的敏感性。所以,當我們拿到一款新產品,比如Moderna的mRNA疫苗的時候,我們需要搞清楚它特定的處理要求,以及非常具體、相當復雜的生產流程。但我們有足夠的能力與Moderna通力合作,我們知道如何大幅度提升這種疫苗的生產規模?!?/p>

        其他制造商也各有專長。Emergent BioSolutions正在協助強生和阿斯利康生產疫苗,其生產過程涉及到一些不同于mRNA疫苗的老派技能。順便說一句,該公司的巴爾的摩生產基地最近發生了一起事故,導致數百萬劑新冠疫苗被毀。

        有鑒于此,制藥商或許需要向外包制造商分享一些技術方法,以確保疫苗的安全生產。但這也是讓世界免疫的必要條件。

        這些公司將如何應對冠狀病毒新菌株?

        這一切對未來意味著什么?畢竟,正如我們在新冠病毒身上看到的那樣,病毒會不斷進化。所以企業也必須不斷進化,才能夠迎接瞬息萬變的挑戰。它們能否做到這一點,則是一個更加開放的問題,特別是如果新冠病毒開始變得像流感那樣,需要人們每年打新的加強針才可以獲得抗體的話。

        PATH的布萊耶強調稱,考慮到新冠疫情的性質和不斷演變的技術,現在推測還為時過早。但他和其他多位接受《財富》雜志采訪的專家表示,在新冠病毒問題上,外包制造商未來的成功取決于它們的經驗、現有能力,以及學習新技巧的意愿。

        “擁有這種新型mRNA疫苗生產技能的制造商,其實并不多?!辈既R耶補充說,不那么復雜的新冠疫苗能夠“相對容易地轉移到外包制造商那里生產?!?/p>

        “但找到一家既可以處理初級制造,又能夠處理mRNA疫苗二級制造的外包制造商,則是一件復雜得多的事情?!彼f。

        這就體現出機構記憶的重要性??堤﹤愄氐娜R利對此進行了一番詮釋?!拔覀冊缭趲啄昵熬团cModerna合作,幫助它們開展個性化癌癥疫苗項目,從而對mRNA治療劑有了一定的認知?!彼f,“我們當然看到了這項技術的潛力,也看到了開發產能、知識和能力來支持這類項目的種種好處?!?/p>

        這就是不斷演變的科學和藥物研發的本質,而這種動態在新冠疫情期間發展得更加迅速。包括大型制藥公司和小型生物技術公司在內,各路參與者不僅需要相互分享知識,還必須向它們的外包制造合作伙伴分享專有技術。

        這有可能促使藥品制造領域迎來一場變革:規模較小的合同外包制造組織將專注于生產更加傳統的藥物,而規模更大的制造商則利用更多的資源來幫助對抗這種病毒,并從中學習新知識。(財富中文網)

        譯者:任文科

        When you have a global pandemic like COVID brushing up against the labyrinthine business dynamics of the drug industry, things can get tricky. Simply inventing a new vaccine or therapeutic is a time-consuming and unpredictable process in and of itself. And then you have to actually make this new product at scale so that shots can be delivered to vaccine sites and administered into arms.

        That makes on-the-ground contract manufacturers—companies that may not be household names but serve a critical role in the drugmaking process—particularly important in this moment. These are the companies that help manufacture drug doses or carry out other important functions that not all drugmakers have the capacity to do, such as putting a COVID vaccine into vials so they can actually get to patients.

        The COVID outbreak has led to a spider’s web of relationships among these third-party contract firms and the pharma industry partners they work with, and experts tell Fortune that it’s tough to predict outright how the pandemic may reshape these outsourcing companies’ bottom lines and their business strategies—not to mention what their roles will be in the future as variant strains of the coronavirus emerge.

        Some of the giants in the drug contract-manufacturing space may benefit from knowledge of a certain coronavirus vaccine technology to maximize doses; others may not have the capacity or know-how to create customized biological ingredients relying on new vaccine platforms such as Pfizer’s and Moderna’s messenger RNA (mRNA)-based tech, but still may be able to scale up other kinds of COVID shots from companies like Johnson & Johnson or AstraZeneca. And still others may have to take on bigger roles in manufacturing non-COVID pharmaceuticals as giants like Pfizer focus their own manufacturing facilities on vaccine production.

        “The good news is that there is enough capacity worldwide,” says Simone Blayer, a chemical engineer and pharma industry veteran who is now the head of chemistry, manufacturing, and control at the nonprofit PATH, which works to help improve vaccine production and equity around the world. “So then we see that the hardware, the volume of manufacturing, that is available for worldwide production meets the demand.”

        Middlemen abound in the life sciences business generally. During a public health emergency, ad hoc relationships must be and have been struck between rivals and industry players globally to ensure that as many vaccine doses as feasible wind up in as many arms as possible, industry executives relayed to Fortune. There are just three emergency-authorized COVID vaccines in the U.S., with Johnson & Johnson's on a temporary pause over potential safety concerns. More than 192 million doses have already been administered across the country as of April 13, according to the CDC.

        What happens for individual contract-manufacturing firms going forward is a far more nuanced story.

        What are these companies and what do they do, anyway?

        It might be easy to think that drugmakers, the so-called innovator companies behind a pharmaceutical product, are the only real parties involved in rolling out a new therapy. These include companies like Pfizer and its partner BioNTech, and Moderna, which both leveraged pioneering mRNA technology to win the first authorizations for COVID vaccines in the U.S. Johnson & Johnson and AstraZeneca both utilize something called an adenovirus, or cold virus, to create their vaccines, although J&J uses a human adenovirus while AstraZeneca uses one from a chimpanzee. Dozens upon dozens of other coronavirus vaccines are in various stages of clinical trials or authorization around the world, encompassing pharmaceutical giants and life science industry upstarts alike.

        But once a product is proven, many pharma companies rely on outsourced manufacturing. The ever-changing innovation in the field requires these manufacturers to have sharp in-house scientific expertise and the willingness to take risks on unproven products during an emergency. And producing that initial substance, the “bulk” biological substance that makes up the core of something like a vaccine, is no mean feat.

        But despite the less than ideal business conditions, this type of manufacturing is only gaining steam. Biopharmaceutical firms’ reliance on outsourced manufacturing for drugs of all stripes is a growing market, according to analysts. A report from Grand View Research finds that the global contract-manufacturing and development market for drugs will balloon to $157.7 billion by 2025, representing a 6.9% compound annual growth rate over seven years. That would make for a faster rate of growth among these third-party players than in the pharma industry itself.

        How COVID has shaken up the industry landscape

        “The coronavirus pandemic has resulted in disruptions in the supply chain of the overall pharmaceutical industry,” writes Grand View Research analysts in a more recent report on COVID’s effects on industry. “However, the biopharmaceutical [contract manufacturers and researchers] have responded well to the outbreak as such organizations are the beneficiaries of supply-chain disruptions.”

        Depending on the exact COVID vaccine, pharma companies are exploring different strategies for working with manufacturers based on their vaccines' individual technologies.

        For instance, Pfizer’s vaccine has such specialized requirements, particularly with its cold-chain requirements that necessitate super-cooled storage and distribution, that the drugmaker has largely relied on its own existing manufacturing facilities to scale up the product. The company has stated that it has some 40 sites that it owns to ramp up vaccine production and more than 200 suppliers who assist in the distribution process. Pfizer has outsourced production of its non-COVID drugs to outside manufacturers to clear up space for vaccine production at its own plants.

        For mRNA-based vaccines, which rely on breaking down the genetic code of a virus and potential future variants of a pathogen, you need some institutional know-how. That’s why the likes of Catalent and Switzerland-based manufacturer Lonza have a distinct advantage over smaller contract manufacturers that don’t have the requisite institutional knowledge or infrastructure to make mRNA vaccines.

        Catalent, for instance, is supporting the scale-up of more than 80 COVID-related therapeutics and vaccines, including the manufacturing of Moderna’s, AstraZeneca’s, and Johnson & Johnson’s vaccines. The company already produces more than 70 billion doses of 7,000-plus pharmaceutical products around the globe annually and works with over 1,000 customers. This year, it expects to produce over 1 billion doses of COVID vaccines and therapeutics across more than 80 individual pandemic-related programs, according to the company.

        The company, which has $3 billion a year in revenues, also plays a big role in the nuts and bolts of safely putting vaccine doses into a vial (in industry jargon, “fill and finish”).

        Lonza, which is working with Moderna to scale up its vaccine, referred Fortune to the smaller biotech company.

        “For us, with mRNA in particular, I would say, the contractors are an especially critical path upfront as suppliers, to help with our processes,” says Ray Jordan, chief corporate officer at Moderna and coincidentally a veteran of both Pfizer and Johnson & Johnson. “And then downstream to things like fill and finish, which is where once you have your drug substance and you're then trying to get it into the usable vials and so on, that process is not one that we have. So, we're entirely dependent on contract firms for that.”

        That requires cross-industry collaboration during a global outbreak. “We're experienced running different types of complex biologic products into that fill process and scaling those products up,” says Mike Riley, president of Catalent’s North America biologics department. “Every product is a little bit different. It has its own sensitivities. And so when we have a new product, like, say, Moderna’s mRNA vaccine, it has specific handling requirements, has a very specific process that has a lot of complexity to it. But we have enough capability working in partnership with Moderna that we can figure out how to scale that product up to much larger scale.”

        Other manufacturers have different expertise. Emergent BioSolutions, which had a recent snafu at a COVID manufacturing site in Baltimore that led to millions of wasted COVID vaccine doses, is assisting both Johnson & Johnson and AstraZeneca in those production efforts, which require a somewhat more old-school skill set than the mRNA vaccines.

        This may require a drugmaker to share some of its technological methods with contract manufacturers in order to ensure the safe production of these vaccines. But it’s also what’s necessary to immunize the world.

        How will these companies handle new COVID strains?

        What does all of this mean for the future? After all, a virus evolves, as we’ve already seen with COVID-19. Businesses have to evolve to meet the moment as well. Whether or not they’ll be able to is a more open question, especially if the coronavirus begins to resemble the flu, necessitating new booster shots every year as the virus evolves.

        PATH’s Blayer emphasizes that it’s too early to speculate, given the nature of the pandemic and constantly shifting technologies. But he, and multiple other experts who spoke with Fortune, said the success of contracting firms going forward when it comes to COVID will depend on their experience and existing capabilities—and willingness to learn new tricks.

        “There aren't really a lot of players who are technologically capable of manufacturing these kinds of new vaccines of mRNA,” says Blayer, adding that less complex COVID vaccines could be “transferred to a contract manufacturer relatively easily.”

        “Having a contract manufacturer that is capable of handling primary manufacturing but also secondary manufacturing of mRNA is much more complex,” he says.

        It’s a point of institutional memory that Catalent’s Riley drives home. “We got involved in mRNA therapeutics several years ago, through a partnership with Moderna, in their personalized cancer vaccine program,” he says. “And we certainly saw the potential in the technology, and saw the benefit in developing capabilities and knowledge and capacity to be able to support these types of programs.”

        Such is the nature of evolving science and drug development—a dynamic that has played out even more rapidly during the pandemic. Players from big pharma to small biotech will have to share knowledge with each other and their contract-manufacturing partners, and that could lead to a shift wherein smaller CMOs focus on more conventional drugs while larger ones shift more resources to helping in, and learning from, the fight against this virus.

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