当新冠病毒这种肆虐全球的传染病遭遇到错综复杂的制药业商业动态时,情况可能会变得相当棘手。
仅仅发明一种新的疫苗或治疗剂本身就是一个耗时且不可预测的过程,接下来,还需要大规模生产这种新产品,以便将疫苗配送到世界各地的接种点,然后注射到人们的手臂上。
这时,外包制造商就显得尤为重要。这些公司的名字可能并非家喻户晓,但它们正在发挥着举足轻重的作用——要么直接参与疫苗的生产,要么履行着并非所有制药商都有能力完成的其他重要功能,比如将新冠疫苗装入小瓶,从而让其能够真正送到患者手中。
新冠疫情的爆发促使这些外包制造商和与之合作的制药业合作伙伴形成了一种犹如蜘蛛网般的关系。多位专家对《财富》杂志表示,目前还很难预测这场疫情会如何重塑这些外包公司的盈亏底线和业务战略,而预判随着冠状病毒变异株出现,它们在未来扮演的角色更是难上加难。
在药品制造领域里,一些巨头级企业可能会凭借着它们了解的某种冠状病毒疫苗技术,最大程度地提升产量;其他企业或许没有这种能力或诀窍,无法依靠新的疫苗平台——例如辉瑞和Moderna合作开发的mRNA技术——来创造定制化的生物成分,但仍然有可能助力其他疫苗实现规模化生产,例如强生或阿斯利康等公司研发的新冠疫苗。
此外,由于辉瑞等制药巨头专注于利用自身的生产设施生产疫苗,还有一些外包制造商可能不得不在生产非新冠药物方面扮演更加重要的角色。
“好消息是,全球有足够的产能。”化学工程师、制药业资深人士西蒙·布莱耶说。他目前在致力于改善全球疫苗生产和公平分配的非营利组织PATH担任化学、制造和控制主管。
“所以我们看到,可以用于全球生产的制造硬件设施和企业数量,足以满足庞大的疫苗需求。”
在生命科学领域中,从来不缺中间商。行业高管向《财富》杂志透露称,一旦爆发公共卫生紧急事件,全球竞争对手和行业参与者就必须建立,并且已经达成临时关系,以确保尽可能多的可用疫苗注入尽可能多的手臂上。美国目前仅有三种获得紧急授权使用的新冠疫苗,其中强生疫苗最近因为潜在的安全问题而被暂时叫停。
根据美国疾病控制与预防中心的数据,截至4月13日,全美已经注射了超过1.92亿剂疫苗。
对单个外包制造商来说,未来的情况则要微妙得多。
这些公司究竟是何方神圣,它们到底是做什么的?
人们可能很容易认为,制药商,即所谓的药品创新公司,是唯一真正参与新疗法推出过程的企业,其中包括辉瑞及其合作伙伴BioNTech,以及Moderna等公司。这些公司都利用开创性的mRNA技术赢得了美国首批新冠疫苗的紧急使用授权。
强生和阿斯利康则利用一种被称为腺病毒或感冒病毒的东西来制造疫苗,尽管强生使用的是人类腺病毒,而阿斯利康使用的是黑猩猩腺病毒。
在世界各地,还有数十种冠状病毒疫苗处于不同的临床试验或授权阶段,其开发商既有制药巨头,也有一些新近崛起的生命科学企业。
不过,一旦产品得到验证,许多制药公司就会依赖外包生产。该领域里瞬息万变、层出不穷的创新,要求这些外包制造商自身拥有敏锐的科学专业知识,并且愿意在紧急情况下为未经验证的产品承担风险。而生产这种初始物质,即构成疫苗等核心产品的生物“原料药”,绝非易事。
但是,尽管商业条件不那么理想,这种类型的制造只会越来越多。分析师称,生物制药公司往往会将各种药物的生产环节外包出去,这是一个不断增长的市场。
根据Grand View Research发布的报告,到2025年,全球药品外包合同制造和开发市场将激增至1577亿美元——意味着未来七年的年复合增长率高达6.9%。这将让这些第三方参与者的增长速度超过制药行业本身。
新冠疫情如何撼动行业格局
“新冠疫情已经瓦解了整个制药业的供应链。”Grand View Research的分析师在最近发布的一份关于新冠疫情对行业影响的报告中写道。“然而,生物制药(外包制造商和研究机构)对疫情反应良好,因为此类组织恰恰是供应链中断的受益者。”
根据新冠疫苗的具体情况,制药公司正在基于各自的疫苗技术,探索不同的战略与外包制造商开展合作。
例如,辉瑞的疫苗有着非常专业化的要求,特别是在冷链方面——它需要采用超低温储存和配送。正因如此,这家制药商主要依靠自己现有的设施来扩大生产规模。
该公司表示,它拥有大约40家工厂来提升疫苗产量,还有200多家供应商协助分销。辉瑞已经将其非冠状病毒药物的生产承包给外部制造商,以便为自家工厂生产疫苗腾出空间。
mRNA疫苗需要分解病毒的遗传密码和病原体未来的潜在变种。要生产这种疫苗,必须得具备一些机构专有技术。这就是为什么康泰伦特和瑞士制造商龙沙集团等公司,比那些不具备生产mRNA疫苗所需的机构技术或基础设施的小型外包制造商具有明显优势。
例如,康泰伦特正在支持80多种新冠病毒治疗剂和疫苗的规模化生产,包括生产Moderna、阿斯利康和强生的疫苗。该公司每年在全球生产7000多种药品,产量超过700亿剂,并与1000多家客户合作。康泰伦特预计今年将参与80多种疫情相关项目,生产逾10亿剂新冠疫苗和治疗剂。
此外,这家年收入30亿美元的公司也在安全地将疫苗装入小瓶(用行业术语来说就是“灌封”)这一关键环节中扮演着重要角色。
目前正在大规模生产Moderna疫苗的龙沙集团,向《财富》杂志引荐了这家规模相对较小的生物技术公司。
Moderna的首席执行官雷·乔丹表示:“对我们来说,尤其是对mRNA疫苗而言,外包制造商在前期扮演着特别关键的角色,以供应商的身份帮助我们完成流程。”颇为巧合的是,他此前曾经供职于辉瑞和强生公司。
“然后就是下游的灌封等环节。一旦药物研发成功,你就需要把它装入可用的小瓶。但这个生产流程是我们所不具备的,所以我们完全依靠外包制造商来完成。”
这就需要在全球疫情爆发期间进行跨行业合作。
“我们在灌封不同类型的复杂生物产品,并大规模生产这些产品方面拥有丰富经验。”康泰伦特的北美生物部门总裁迈克·莱利说,“每个产品都有一点点不同,有着自己的敏感性。所以,当我们拿到一款新产品,比如Moderna的mRNA疫苗的时候,我们需要搞清楚它特定的处理要求,以及非常具体、相当复杂的生产流程。但我们有足够的能力与Moderna通力合作,我们知道如何大幅度提升这种疫苗的生产规模。”
其他制造商也各有专长。Emergent BioSolutions正在协助强生和阿斯利康生产疫苗,其生产过程涉及到一些不同于mRNA疫苗的老派技能。顺便说一句,该公司的巴尔的摩生产基地最近发生了一起事故,导致数百万剂新冠疫苗被毁。
有鉴于此,制药商或许需要向外包制造商分享一些技术方法,以确保疫苗的安全生产。但这也是让世界免疫的必要条件。
这些公司将如何应对冠状病毒新菌株?
这一切对未来意味着什么?毕竟,正如我们在新冠病毒身上看到的那样,病毒会不断进化。所以企业也必须不断进化,才能够迎接瞬息万变的挑战。它们能否做到这一点,则是一个更加开放的问题,特别是如果新冠病毒开始变得像流感那样,需要人们每年打新的加强针才可以获得抗体的话。
PATH的布莱耶强调称,考虑到新冠疫情的性质和不断演变的技术,现在推测还为时过早。但他和其他多位接受《财富》杂志采访的专家表示,在新冠病毒问题上,外包制造商未来的成功取决于它们的经验、现有能力,以及学习新技巧的意愿。
“拥有这种新型mRNA疫苗生产技能的制造商,其实并不多。”布莱耶补充说,不那么复杂的新冠疫苗能够“相对容易地转移到外包制造商那里生产。”
“但找到一家既可以处理初级制造,又能够处理mRNA疫苗二级制造的外包制造商,则是一件复杂得多的事情。”他说。
这就体现出机构记忆的重要性。康泰伦特的莱利对此进行了一番诠释。“我们早在几年前就与Moderna合作,帮助它们开展个性化癌症疫苗项目,从而对mRNA治疗剂有了一定的认知。”他说,“我们当然看到了这项技术的潜力,也看到了开发产能、知识和能力来支持这类项目的种种好处。”
这就是不断演变的科学和药物研发的本质,而这种动态在新冠疫情期间发展得更加迅速。包括大型制药公司和小型生物技术公司在内,各路参与者不仅需要相互分享知识,还必须向它们的外包制造合作伙伴分享专有技术。
这有可能促使药品制造领域迎来一场变革:规模较小的合同外包制造组织将专注于生产更加传统的药物,而规模更大的制造商则利用更多的资源来帮助对抗这种病毒,并从中学习新知识。(财富中文网)
译者:任文科
当新冠病毒这种肆虐全球的传染病遭遇到错综复杂的制药业商业动态时,情况可能会变得相当棘手。
仅仅发明一种新的疫苗或治疗剂本身就是一个耗时且不可预测的过程,接下来,还需要大规模生产这种新产品,以便将疫苗配送到世界各地的接种点,然后注射到人们的手臂上。
这时,外包制造商就显得尤为重要。这些公司的名字可能并非家喻户晓,但它们正在发挥着举足轻重的作用——要么直接参与疫苗的生产,要么履行着并非所有制药商都有能力完成的其他重要功能,比如将新冠疫苗装入小瓶,从而让其能够真正送到患者手中。
新冠疫情的爆发促使这些外包制造商和与之合作的制药业合作伙伴形成了一种犹如蜘蛛网般的关系。多位专家对《财富》杂志表示,目前还很难预测这场疫情会如何重塑这些外包公司的盈亏底线和业务战略,而预判随着冠状病毒变异株出现,它们在未来扮演的角色更是难上加难。
在药品制造领域里,一些巨头级企业可能会凭借着它们了解的某种冠状病毒疫苗技术,最大程度地提升产量;其他企业或许没有这种能力或诀窍,无法依靠新的疫苗平台——例如辉瑞和Moderna合作开发的mRNA技术——来创造定制化的生物成分,但仍然有可能助力其他疫苗实现规模化生产,例如强生或阿斯利康等公司研发的新冠疫苗。
此外,由于辉瑞等制药巨头专注于利用自身的生产设施生产疫苗,还有一些外包制造商可能不得不在生产非新冠药物方面扮演更加重要的角色。
“好消息是,全球有足够的产能。”化学工程师、制药业资深人士西蒙·布莱耶说。他目前在致力于改善全球疫苗生产和公平分配的非营利组织PATH担任化学、制造和控制主管。
“所以我们看到,可以用于全球生产的制造硬件设施和企业数量,足以满足庞大的疫苗需求。”
在生命科学领域中,从来不缺中间商。行业高管向《财富》杂志透露称,一旦爆发公共卫生紧急事件,全球竞争对手和行业参与者就必须建立,并且已经达成临时关系,以确保尽可能多的可用疫苗注入尽可能多的手臂上。美国目前仅有三种获得紧急授权使用的新冠疫苗,其中强生疫苗最近因为潜在的安全问题而被暂时叫停。
根据美国疾病控制与预防中心的数据,截至4月13日,全美已经注射了超过1.92亿剂疫苗。
对单个外包制造商来说,未来的情况则要微妙得多。
这些公司究竟是何方神圣,它们到底是做什么的?
人们可能很容易认为,制药商,即所谓的药品创新公司,是唯一真正参与新疗法推出过程的企业,其中包括辉瑞及其合作伙伴BioNTech,以及Moderna等公司。这些公司都利用开创性的mRNA技术赢得了美国首批新冠疫苗的紧急使用授权。
强生和阿斯利康则利用一种被称为腺病毒或感冒病毒的东西来制造疫苗,尽管强生使用的是人类腺病毒,而阿斯利康使用的是黑猩猩腺病毒。
在世界各地,还有数十种冠状病毒疫苗处于不同的临床试验或授权阶段,其开发商既有制药巨头,也有一些新近崛起的生命科学企业。
不过,一旦产品得到验证,许多制药公司就会依赖外包生产。该领域里瞬息万变、层出不穷的创新,要求这些外包制造商自身拥有敏锐的科学专业知识,并且愿意在紧急情况下为未经验证的产品承担风险。而生产这种初始物质,即构成疫苗等核心产品的生物“原料药”,绝非易事。
但是,尽管商业条件不那么理想,这种类型的制造只会越来越多。分析师称,生物制药公司往往会将各种药物的生产环节外包出去,这是一个不断增长的市场。
根据Grand View Research发布的报告,到2025年,全球药品外包合同制造和开发市场将激增至1577亿美元——意味着未来七年的年复合增长率高达6.9%。这将让这些第三方参与者的增长速度超过制药行业本身。
新冠疫情如何撼动行业格局
“新冠疫情已经瓦解了整个制药业的供应链。”Grand View Research的分析师在最近发布的一份关于新冠疫情对行业影响的报告中写道。“然而,生物制药(外包制造商和研究机构)对疫情反应良好,因为此类组织恰恰是供应链中断的受益者。”
根据新冠疫苗的具体情况,制药公司正在基于各自的疫苗技术,探索不同的战略与外包制造商开展合作。
例如,辉瑞的疫苗有着非常专业化的要求,特别是在冷链方面——它需要采用超低温储存和配送。正因如此,这家制药商主要依靠自己现有的设施来扩大生产规模。
该公司表示,它拥有大约40家工厂来提升疫苗产量,还有200多家供应商协助分销。辉瑞已经将其非冠状病毒药物的生产承包给外部制造商,以便为自家工厂生产疫苗腾出空间。
mRNA疫苗需要分解病毒的遗传密码和病原体未来的潜在变种。要生产这种疫苗,必须得具备一些机构专有技术。这就是为什么康泰伦特和瑞士制造商龙沙集团等公司,比那些不具备生产mRNA疫苗所需的机构技术或基础设施的小型外包制造商具有明显优势。
例如,康泰伦特正在支持80多种新冠病毒治疗剂和疫苗的规模化生产,包括生产Moderna、阿斯利康和强生的疫苗。该公司每年在全球生产7000多种药品,产量超过700亿剂,并与1000多家客户合作。康泰伦特预计今年将参与80多种疫情相关项目,生产逾10亿剂新冠疫苗和治疗剂。
此外,这家年收入30亿美元的公司也在安全地将疫苗装入小瓶(用行业术语来说就是“灌封”)这一关键环节中扮演着重要角色。
目前正在大规模生产Moderna疫苗的龙沙集团,向《财富》杂志引荐了这家规模相对较小的生物技术公司。
Moderna的首席执行官雷·乔丹表示:“对我们来说,尤其是对mRNA疫苗而言,外包制造商在前期扮演着特别关键的角色,以供应商的身份帮助我们完成流程。”颇为巧合的是,他此前曾经供职于辉瑞和强生公司。
“然后就是下游的灌封等环节。一旦药物研发成功,你就需要把它装入可用的小瓶。但这个生产流程是我们所不具备的,所以我们完全依靠外包制造商来完成。”
这就需要在全球疫情爆发期间进行跨行业合作。
“我们在灌封不同类型的复杂生物产品,并大规模生产这些产品方面拥有丰富经验。”康泰伦特的北美生物部门总裁迈克·莱利说,“每个产品都有一点点不同,有着自己的敏感性。所以,当我们拿到一款新产品,比如Moderna的mRNA疫苗的时候,我们需要搞清楚它特定的处理要求,以及非常具体、相当复杂的生产流程。但我们有足够的能力与Moderna通力合作,我们知道如何大幅度提升这种疫苗的生产规模。”
其他制造商也各有专长。Emergent BioSolutions正在协助强生和阿斯利康生产疫苗,其生产过程涉及到一些不同于mRNA疫苗的老派技能。顺便说一句,该公司的巴尔的摩生产基地最近发生了一起事故,导致数百万剂新冠疫苗被毁。
有鉴于此,制药商或许需要向外包制造商分享一些技术方法,以确保疫苗的安全生产。但这也是让世界免疫的必要条件。
这些公司将如何应对冠状病毒新菌株?
这一切对未来意味着什么?毕竟,正如我们在新冠病毒身上看到的那样,病毒会不断进化。所以企业也必须不断进化,才能够迎接瞬息万变的挑战。它们能否做到这一点,则是一个更加开放的问题,特别是如果新冠病毒开始变得像流感那样,需要人们每年打新的加强针才可以获得抗体的话。
PATH的布莱耶强调称,考虑到新冠疫情的性质和不断演变的技术,现在推测还为时过早。但他和其他多位接受《财富》杂志采访的专家表示,在新冠病毒问题上,外包制造商未来的成功取决于它们的经验、现有能力,以及学习新技巧的意愿。
“拥有这种新型mRNA疫苗生产技能的制造商,其实并不多。”布莱耶补充说,不那么复杂的新冠疫苗能够“相对容易地转移到外包制造商那里生产。”
“但找到一家既可以处理初级制造,又能够处理mRNA疫苗二级制造的外包制造商,则是一件复杂得多的事情。”他说。
这就体现出机构记忆的重要性。康泰伦特的莱利对此进行了一番诠释。“我们早在几年前就与Moderna合作,帮助它们开展个性化癌症疫苗项目,从而对mRNA治疗剂有了一定的认知。”他说,“我们当然看到了这项技术的潜力,也看到了开发产能、知识和能力来支持这类项目的种种好处。”
这就是不断演变的科学和药物研发的本质,而这种动态在新冠疫情期间发展得更加迅速。包括大型制药公司和小型生物技术公司在内,各路参与者不仅需要相互分享知识,还必须向它们的外包制造合作伙伴分享专有技术。
这有可能促使药品制造领域迎来一场变革:规模较小的合同外包制造组织将专注于生产更加传统的药物,而规模更大的制造商则利用更多的资源来帮助对抗这种病毒,并从中学习新知识。(财富中文网)
译者: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.