Less than a year after identifying the novel coronavirus that causes COVID-19, biopharmaceutical researchers have made tremendous progress toward developing safe and effective vaccines. By collaborating across industry and with scientists, governments and multilateral organizations across the world, several companies have worked to advance potential candidates.

 

As we look toward the next phase of our fight against COVID-19, ensuring sufficient manufacturing capacity, maintaining our commitment to safety, and supporting the effective, equitable distribution of treatments and vaccines is paramount to continued success.

 

Here are 3 ways biopharmaceutical companies are getting prepared:

 

 

Manufacturing

 

Normally, a company develops the manufacturing process and builds manufacturing capacity as a medicine progresses through clinical development—a process that usually takes years. Once a treatment or vaccine is ready for launch commercially, a central supply chain is already in place and manufacturing capacity is increased proportional to market uptake of the product over time.

 

During the pandemic, the urgent need for effective treatments and vaccines has required a different approach, and many biopharmaceutical companies are changing how they produce and manufacture a vaccine at scale and pace.

 

In fact, some companies, such as AstraZeneca, have already started manufacturing a potential vaccine so that, should clinical trials prove successful and the vaccine be approved by regulators, it will be available to support broad and equitable access. This is despite the immense uncertainty and investment required to scale production without assurance of an approval.

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How COVID-19 Is Advancing the Biomedical R&D Process

As we face COVID-19, America's biopharmaceutical researchers have undertaken monumental efforts to advance the research and development process of the future.

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“It is very important to us at AstraZeneca that we can produce as much vaccine as possible to ensure broad, equal access as soon as possible after a potential approval,” said Per Alfredsson, Senior Vice President, Global Biologics Operations, at AstraZeneca. “Accelerating production at this kind of scale requires partners around the world with capabilities to manufacture using our standard process to ensure consistency and quality of the vaccine.”

 

Safety

 

As a vaccine develops, researchers closely monitor data, including any reports of adverse events, throughout the clinical trial to understand the safety profile of the vaccine and take steps as appropriate to improve the safety profile. And if a vaccine candidate is found to be safe and effective and receives regulatory approval from the U.S. Food and Drug Administration (FDA), biopharmaceutical companies continue to take steps to help ensure product safety, including through manufacturing controls that help ensure quality and through surveillance and assessment of any potential adverse events following approval.

“The safety and high quality of a medicine or vaccine is absolutely paramount. That is why safety and quality control are embedded throughout the production process. More than 60 tests are carried out during the making of every batch of vaccine,” said Darrin Cowley, Head of Development Quality, Biologics, at AstraZeneca.

During the course of vaccine development, scientists seek to understand the impact of a range of factors on the vaccine candidate such as heat, light, radiation, environmental changes, as well as interaction with container materials. At each stage of the process, experts define manufacturing, storage and handling conditions to optimize product stability and shelf life, as well as to ensure safety, quality and efficacy are maintained.

 

Finally, companies like AstraZeneca help ensure that all manufacturing partners meet regulatory requirements of the FDA and other regulators regarding manufacturing practices and quality.

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COVID-19 Treatment Progress

America’s biopharmaceutical companies are coming together to achieve one common goal: ending COVID-19. Our shared heritage of discovery and research allows us to respond to the coronavirus swiftly, with active trials for both treatments and vaccines already underway.

A Global Effort

 

From across the biopharmaceutical ecosystem, manufacturing and other supply chain experts, engineers, technical scientists and quality control professionals are working in parallel with clinical development to rapidly apply innovative thinking to commercial vaccine production.

 

Vaccine development is incredibly complex and risky, but biopharmaceutical researchers have the specialized skills and experience to navigate development and manufacturing successfully, and they understand the pressing need for a safe and effective vaccine to help combat COVID-19. The industry accepts and is prepared for its unique leading role to play amid the current pandemic and continues to rapidly mobilize its scientific expertise and resources to tackle these threats head on.

 

Learn more about AstraZeneca’s efforts to ensure safe and reliable vaccine production here.

 

Learn more about PhRMA member company efforts to beat COVID-19 at PhRMA.org/Coronavirus