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What is Advanced Medical Manufacturing?

The FDA defined advanced manufacturing as “a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market.” The FDA also emphasizes the public health advantages of adopting continuous and additive manufacturing methods.
What is Advanced Manufacturing

Advanced manufacturing is a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. Every field has a different set of production techniques that are considered advanced. They often:

  1. Integrate novel technological approaches
  2. Use established techniques in a new or innovative way, or
  3. Apply production methods in a new domain where there are no defined best practices or experience.

Examples of some cross-cutting advanced manufacturing technologies include continuous manufacturing and 3D printing.

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Why is advanced manufacturing important to public health emergency preparedness and response?

Innovations in manufacturing technology will help:

  • Rapidly scale manufacturing capabilities for vaccines and other medical countermeasures (MCMs) to respond faster to emerging threats and other public health emergencies, such as pandemic influenza
  • Shorten supply chains and increase manufacturing resilience to disruption by emerging threats or public health emergencies, such as natural disasters, by creating a distributed network of small manufacturing sites that can provide reserve capacity for centralized manufacturing facilities
  • Accelerate therapy development for orphan diseases by improving the cost-efficiency of small-scale manufacturing processes
  • Speed availability of emerging therapies by enabling manufacturing process and standards development, including for cell and gene-therapies, supporting goals of the 21st Century Cures Act (Cures Act)
  • Provide new tools to address drug shortages and other challenges, including pharmaceutical quality

Collaborating to help facilitate next-generation influenza vaccines
Current influenza vaccine manufacturing requires about six months, which requires public health authorities to identify in advance the influenza strains likely to cause the most illness in the upcoming U.S. flu season to ensure availability of vaccine. FDA is collaborating with federal partners and with industry to improve the manufacturing of the current generation of influenza vaccines and facilitate the next generation of influenza vaccines.

Continuous manufacturing

Continuous manufacturing provides a quicker, more reliable way to make pharmaceuticals. FDA is helping bring this method into widespread use.

Continuous manufacturing integrates traditional step-wise manufacturing processes into a single system based on modern process monitoring and controls. In a CM process, product is made over time so a drug manufacturer can easily control the amount of products being made to match demand. These efficient, integrated continuous systems also require smaller footprints to operate.

Additive manufacturing (e.g., 3D printing)

Continuous manufacturing provides a quicker, more reliable way to make pharmaceuticals. FDA is helping bring this method into widespread use.

Continuous manufacturing integrates traditional step-wise manufacturing processes into a single system based on modern process monitoring and controls. In a CM process, product is made over time so a drug manufacturer can easily control the amount of products being made to match demand. These efficient, integrated continuous systems also require smaller footprints to operate.

How can advanced manufacturing support pandemic preparedness?

Unlike other medicines, biopharmaceuticals are manufactured in, extracted from, or otherwise derived from biological sources and require complex manufacturing processes. For example, there’s often more than one type of influenza virus circulating each season, so influenza vaccines are designed to target three or four influenza viruses that are most likely to circulate during the season. Since it generally takes several months for influenza vaccines to be produced, flu strains for the next season need to be selected months in advance to ensure we’re prepared with enough supply when flu season hits.

Advanced manufacturing technologies could potentially allow us to:

  • Produce influenza vaccines closer to flu season, when we might have more certainty about the circulating strain
  • Switch the strain more easily in the event of an unforeseen change
  • Produce a new vaccine more quickly in the event of a pandemic
  • More easily scale manufacturing if vaccine supplies should run short

FDA is encouraging steps to invest in advanced domestic manufacturing to ensure new and existing technologies are scalable so that manufacturers can meet domestic and global demand. For example, we’re working to facilitate development of more effective cell lines that can be better scaled through advanced manufacturing technologies, and we are looking for ways to design a more robust recombinant vaccine manufacturing process could be developed to increase yield, while reducing cost.

Read the original article on FDA.gov

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