In February, engineer-procure-construct contractor CRB was in the final stages of construction on a new production facility for Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, Mich.

流程资格（联邦和制药行业当局都在检查和批准制造工厂，最多可能需要一年的步骤。该工厂是由CRB设计和建造的，旨在制定和生产由约翰逊和约翰逊，阿斯利康和辉瑞等公司开发和拥有的医生处方的药物。然后Covid-19发生了。

”的尾端project is really when COVID hit," says Jesse Adams, CRB's senior project manager. "Some of those [qualification] elements really had to be expedited and focused. In terms of the brick-and-mortar elements, we were near completion."

The 61,500-sq-ft facility was ready to begin production of a COVID-19 vaccine by July and is contracted for a full year of production with a division of Johnson & Johnson as part of the federal Operation Warp Speed effort to expedite vaccines to market. It was one project exempted from Michigan Gov. Gretchen Whitmer's original stay-at-home order for construction because it would make life-saving medicine.

Trade contractors were even less available than usual to Adams' team as the pandemic hit, however, and site equipment availability was also affected by the slowdown in global supply chains.

亚当斯说，这是“与设备生产有关的问题，都要多。”“每个人都被预订了，从制造业的角度来看，能力确实没有。我们的贸易承包商被超额预订了。这是一个非常忙碌的时间和非常关键的时间。”

Qualified on Time

尽管有2020年初的障碍，但新设施还是按时完成并有资格。美国的三个克制药设施之一之一，旨在提高公司的大规模填充和完成能力。用药物（通常是疫苗）填充小瓶的过程是包装分发之前的最后一步。

The pandemic will test the capacity of contract and development manufacturing firms such as GRAM in the coming months. No pandemic vaccine has ever needed to be this widely distributed in the U.S. The groundbreaking polio vaccine developed by Dr. Jonas Salk and distributed in the 1960s is the only comparable rollout with an even closely comparable pharmaceutical industry response—and that was only given to children.

"It's been interesting because you're working on getting a facility up and running and getting it qualified," says John Wichelt, GRAM vice president of client pharmaceutical services. "At the same time, we were also working on getting our manufacturing process in place as soon as the government and Johnson & Johnson say, 'go ... start making it a vaccine.'"

诸如GRAM之类的制造商有能力为其中的任何产品更改其填充和其他生产线。

"Some of our clients want pharmaceutical lines that will be dedicated to a single product," Wichelt says. "GRAM is set up to have a little more flexibility. Since we're a CDMO—a contract development manufacturing organization—we make products for numerous customers. We have to have that flexibility, not just in the design of the filling line, but in the design of the facility as well to be able to manufacture lots of different types of products. That was critical in the design for CRB."

虽然Gram的能力将于明年的Covid-19疫苗承诺，但灵活的建筑物设计将使它可以在将来生产其他药物。克是为了获得联邦批准而制造的数百万剂COVID-19-19-19-COVID-19疫苗的众多CDMO之一。它的大部分生产已经完成，正在等待冷藏仓库推出。

辉瑞, the company that was first to ask the federal Food and Drug Administration for emergency approval of its vaccine, has already planned its manufacturer-to-provider supply chain. One complication is that its vaccine must be stored at temperatures below -94° F.

即时系统

辉瑞全球供应通信经理Francesca Marzullo说：“我们已经制定了详细的后勤计划和工具，以支持有效的疫苗运输，存储和连续的温度监测。”“我们的分布建立在灵活的即时系统上，该系统将把冷冻的小瓶运送到疫苗接种点。”

Marzullo说，该系统包括在第一年分配多达5000万次疫苗剂量。

Because there are so few cold storage facilities that are cold enough to store vaccine [the average temperature on Mars is only -81° F comparatively, according to NASA], the dry-ice-reinforced packaging is being designed to hold it at pharmacies, hospitals and doctors' offices for up to 10 days.

Some pharmacies and hospitals have medical freezers designed to hold medicines that need to be kept in extreme cold, but Pfizer and its German vaccine partner BioNTech are preparing the packaging for long-term use since most of those freezers are too small to store bulk shipments of the vaccine.

Marzullo said the distribution approach will primarily be to ship from Pfizer's Kalamazoo, Mich., fill-and-finish facility directly to point of use, generally a hospital, doctor's office or pharmacy. She said the company may also use its existing distribution center in Pleasant Prairie, Wis., for COVID-19 shipments.

她解释说：“该配送中心将有一个专门的区域指定用于存储产品，该产品不会直接从我们的Kalamazoo站点到使用。”

Both the manufacturing investments of companies like GRAM and the logistics investments of pharmaceutical companies will be tested by the manufacturing and delivery of the largest vaccine rollout in American history, experts report.