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  1. OCET Advanced Manufacturing

About Advanced Manufacturing for Public Health Emergency Preparedness and Response

Advanced manufacturing can help rapidly scale manufacturing capabilities, increase supply chain resilience, and provide new tools to address drug shortages

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An FDA researcher completes a 3D print of several clinical and research tools for patient-specific medicine (FDA photo)
Caption
An FDA researcher completes a 3D print of several clinical and research tools for patient-specific medicine (FDA photo)

On this page: What is advanced manufacturing? | Why is it important to public health emergency response? | Understanding the terminology | FDA's role | Supporting the supply chain | Related programs from across FDA

What is advanced manufacturing?

Advanced manufacturing is a collective term for new or innovatively applied 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.

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

Innovations in manufacturing technology can 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

For example, traditional 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.

Advanced biopharmaceutical manufacturing to support pandemic response

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.

Understanding the terminology

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

Additive manufacturing methods, such as 3D printing, are capable of making digital 3D models into solid parts by repeatedly layering materials. These methods can be used across all medical products.

3-D printing—the process of making a three-dimensional solid object of virtually any shape from a digital model—is spurring innovation in manufacturing. In December 2017, FDA became the first regulator worldwide to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.

3D printing can create patient-specific medical devices such as implants, surgical guides, or anatomic models. Similarly, 3D-printed solid drug products can be made in various shapes, strengths, and distributions of active and inactive ingredients. Tissue-engineered 3D-printed constructs are also being researched to advance regenerative medicine. This approach provides a unique opportunity to produce medical products that are tailored for individual needs of patients. The capabilities and portability of 3D printing processes also enables distributed manufacturing of complex and advanced medical products in remote or austere conditions.  

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.

Digital stockpile

A digital stockpile does not store physical goods and products. Instead, it stores the electronic plans, instructions, and methods to make and test medical products. Using digital stockpiles relies on one or more trusted suppliers that can make the product from the digital information, either through methods like 3D printing or self-contained distributed manufacturing lines. Ensuring the quality of these products and instilling trust in patients and clinicians is paramount to successful implementation of a digital stockpile. 

Distributed manufacturing

Distributed manufacturing is a set of technologies that allows products to be made at or near the point of use. For example, medical products such as personal protective equipment (PPE), nasal swabs, or even drugs and saline could be made near the point of care to help ameliorate or prevent shortages caused by supply chain disruptions. 

FDA's role

FDA is taking many steps to help realize the potential of advanced manufacturing, including:

  • Issuing guidance on emerging technologies and working with medical product sponsors to clarify regulatory and data requirements necessary to support product applications using advanced manufacturing technologies 
  • Reviewing and approving medical products that are made with continuous manufacturing technologies (e.g., New Drug Applications and Biologics License Applications)
  • Advancing regulatory science to proactively address regulatory challenges presented by advanced and continuous manufacturing technologies

Supporting the supply chain

Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputs

An August 2020 executive order directed FDA, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.

The executive order also directs the FDA to coordinate with our federal partners on a number of additional issues, including strategies for acquiring the products on the list, accelerating domestic manufacturing and identifying and addressing supply chain vulnerabilities. The FDA is working on this coordination. The FDA believes that the adoption of innovative technologies, such as advanced manufacturing techniques could enable U.S.-based pharmaceutical manufacturing to bolster its competitiveness with foreign countries and help ensure a stable supply of drugs critical to the health of U.S. patients. As companies look to increase domestic manufacturing of the products on this list, we encourage them to consider adopting advanced manufacturing technologies. 

Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy

In September 2022, the U.S. Department of Health and Human Services (HHS) announced actions the department will take following the Executive Order signed September 12, 2022 by President Biden launching a National Biotechnology and Biomanufacturing Initiative (NBBI). In its implementation of the Executive Order, HHS intends to leverage biotechnology and biomanufacturing in order to achieve medical breakthroughs, reduce the overall burden of disease, and improve health outcomes.

HHS will lead the U.S. government in strategically advancing biosafety and biosecurity innovation as part of a growing bioeconomy, to ensure biotechnology research and development and biomanufacturing infrastructure break new ground while reducing risk. This includes supporting development of the Advanced Manufacturing Innovation Hub in the FDA’s Office of Counterterrorism and Emerging Threats (OCET) to facilitate creation of regulatory science benchmarks and strategies for platform technologies and to drive collaborations that affect multiple product areas (e.g., smart manufacturing, closed loop process controls).

Related external links:

Related programs from across FDA

OCET Advanced Manufacturing Program (Office of the Chief Scientist, Office of the Commissioner)

The FDA Office of Counterterrorism and Emerging Threats (OCET) has established the OCET Advanced Manufacturing Program for innovative, cross-cutting advanced manufacturing technologies to fill unmet regulatory science needs related to rapidly changing and disruptive needs.

Emerging Technology Program (CDER)

FDA established an Emerging Technology Program in 2014 that works collaboratively with companies to support the adoption and use of advanced manufacturing for both new and existing drugs. The team assists companies that want to implement innovative technology, including continuous manufacturing, by helping them to identify and resolve potential scientific and regulatory challenges and providing guidance to their technology development and implementation.

FDA’s Emerging Technology Program is intended to encourage technology for use in product design and pharmaceutical manufacturing. Video transcript

Also see: CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative

CBER Advanced Technologies Program

In 2019, the FDA Center for Biologics Evaluation and Research (CBER) established the CBER Advanced Technologies Team (CATT) to promote dialogue, education, and input among CBER staff and between CBER and prospective innovators/developers of advanced manufacturing technologies that are intended to be implemented in CBER-regulated products.

3D printing of medical devices (CDRH)

3D printing is a type of additive manufacturing. There are several types of additive manufacturing, but the terms 3D printing and additive manufacturing are often used interchangeably. Here we will refer to both as 3D printing for simplicity.

3D printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. Objects are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI).

The flexibility of 3D printing allows designers to make changes easily without the need to set up additional equipment or tools. It also enables manufacturers to create devices matched to a patient’s anatomy (patient-specific devices) or devices with very complex internal structures. These capabilities have sparked huge interest in 3D printing of medical devices and other products, including food, household items, and automotive parts.

 Medical devices produced by 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations such as crowns, and external prosthetics.

3D printing links

Get the latest advanced manufacturing news from across FDA on our Advanced Manufacturing page. 

 

 

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