Getting to the Point of Care: Bringing Manufacturing to the Patient

Traditional pharmaceutical manufacturing involves centralized production of large volumes of drug products intended to treat large patient populations. Some modifications to this approach have been made to allow for the commercialization of lower-volume therapies that treat rare diseases affecting limited numbers of patients worldwide. With the shift to personalized medicine, more effective, decentralized approaches are increasingly necessary to enable cost-effective production of individualized treatments. Other drivers of interest in point-of-care (PoC), or “bedside” manufacturing, are the need to address drug shortages, increase agility and responsiveness in a dynamic and evolving market, and meet growing government expectations for domestic drug production.¹

In addition to enabling the production of truly personalized medicines, PoC manufacturing has many other benefits, including simplified logistics and shorter treatment delivery times, both of which contribute to lower costs and improved accessibility.^2-4 Decentralization in general also supports greater scalability to meet regional demand and reduces risk through redundancy, leading to enhanced supply-chain security.²

There are, however, quality, regulatory, and other challenges that must be overcome to make PoC manufacturing commonplace. We explore those here.

Is PoC manufacturing still just a concept, or is it an actual option for the production of drug products?

Adoption of PoC manufacturing is still in the early stages, and widespread deployment—along with the overall shift toward more decentralized manufacturing—remains in the future, according to Thomas P. Forbes, Materials Measurement Science Division, National Institute of Standards and Technology (NIST). It is, however, taking place for both small- and large-molecule drugs.⁵

Progress is being made in several areas, notes Forbes. For instance, he points to clinical trials (small batch production scenarios) using 3D printing being conducted at numerous hospitals and related health care facilities.^6-9 In addition, he notes that several pharmacies in the US have commercial 3D printing and automated systems for pharmaceutical compounding. Clinical studies for gene-modified cell therapies leveraging PoC manufacturing solutions are also underway.^10-15

How does PoC manufacturing fit into the overall concept of decentralized manufacturing?

The overall concept of decentralized manufacturing encompasses distributed manufacturing, PoC manufacturing, and often mobile/on-demand manufacturing.¹ “All these approaches represent avenues for moving from a rigid and centralized manufacturing scheme to an agile and adaptable scheme,” Forbes says.

Distributed pharmaceutical manufacturing would entail a larger number of geographically dispersed facilities that use standardized processes yet remain sufficiently flexible to meet local needs, explains Forbes. Mobile and on-demand manufacturing (pop-up facilities or large mobile facilities), meanwhile, would provide an agile response to emergency needs and local disasters, as well as production in remote locations. PoC manufacturing and pharmaceutical compounding take this further and often incorporate hospitals (including those tied with academic institutions), pharmacies, and clinics, with production often on an individual scale.

Is there a difference in PoC manufacturing for small- and large-molecule drugs?

PoC and personalized pharmaceutical manufacturing of small-molecule drugs has progressed further than that for biologics, according to Forbes. He points to the relative simplicity of small-molecule vs biological therapies, as well as the long-standing practice of compounding by pharmacies and related health care facilities as reasons for the lag. There are, in fact, a handful of commercial production platforms based on 3D-printing technologies (eg, solid-state extrusion, direct powder extrusion, or fused deposition modeling) for use in pharmaceutical compounding at pharmacies, outsourcing facilities, and hospitals.^16,17

“Additive manufacturing and 3D-printing technologies have been the main driver behind much of the distributed and PoC small-molecule production developments. Along with these technologies comes automation, which has aided in enabling cost-effectiveness and dose-to-dose reproducibility,” Forbes remarks. For example, an automated printer can produce batches of patient-specific or personalized medicine (eg, eliminating an excipient that the patient is allergic to or meeting a specific pediatric or geriatric dose outside the commercially available range) with minimal user oversight. “Traditionally, patient-specific personalization must be done by hand.”

What are some notable recent developments in PoC cell therapy manufacturing?

Several isolator-based, automated, Good Manufacturing Practice–compliant solutions for chimeric antigen receptor (CAR) and other gene-modified T-cell therapies have been commercialized or are in development from companies and other organizations. These systems are attractive because they are a modular solution that allows manufacturing at the PoC with simplified workflows, safe handling of viral vectors, and maintenance of sterility.¹⁸

The 2 leading products, both of which have been used in clinical trials, are the Miltenyi Biotec CliniMACS Prodigy^19-24 and the Cocoon^25,26 system, which Lonza announced in March 2026 that it is selling back to its original developer, Octane Medical Group (27). Octane Biotech has already signed a letter of intent with commercial-stage CAR T-cell therapy company BioOra to collaborate on the codevelopment and deployment of advanced cell therapies using the Cocoon.²⁸

In August 2025, the EASYGEN (Easy Workflow Integration for Gene Therapy) consortium comprising 18 academic, research, industry and clinical partners, including Fresenius (via Fresenius Kabi) and Charles River Laboratories, announced the receipt of $9.3 million in funding from the European Union’s Innovative Health Initiative to develop an automated, hospital-based CAR T-cell therapy production platform able to produce products in under 24 hours.²⁹

Other technologies under development include a small (ie, the size of a deck of cards) microfluidic, chip-based, automated, and closed system³⁰ and the use of a methylcellulose-based foam containing low doses of viral vector gene therapies.³¹ When the foam is mixed with freshly isolated bone marrow aspirate concentrate and then injected into an ex vivo model of perfused bone marrow, efficient genetic modification of embedded CD34+ progenitor cells is achieved.

What are the advantages of cell-free protein synthesis for PoC biologics manufacturing?

For the PoC production of conventional biologics, cell-free manufacturing is more amenable than traditional cell culture processes, according to Forbes. Cell-free protein synthesis can enable on-demand manufacturing without the need for cold chain distribution (eg, by using freeze-dried/lyophilized cell-free lysate) and the related hurdles of centralized production. He points to the use of this approach for the on-demand production of conjugate vaccines³² and insulin.³³ The Bio-MOD system is a suitcase-sized, machine learning–based, cell-free bioprocessing system for on-demand protein production.³⁴ A microfluidic chip system for cell-free expression and purification of proteins has also been reported.³⁵

How does PoC manufacturing impact quality control?

One of the biggest challenges to PoC manufacturing, regardless of the type of molecule, is quality assurance and control in decentralized manufacturing environments. PoC batches are typically quite small and may even involve producing a product for a single patient. Conventional quality control strategies based on extensive release testing and retained samples cannot be leveraged.¹ The difficulties are heightened for products such as cell therapies that have limited shelf lives, for which real-time process monitoring and product release become increasingly important.¹⁸

Ensuring that medicine produced at one location on one platform will be the same as those produced across other locations and platforms, or even from one production vendor to another, is a second important challenge. Using multiple manufacturing sites also creates inspection difficulties.¹ Therefore, unified quality frameworks are essential.⁵

New technologies and avenues for onsite quality assurance and control are crucial to the success of PoC production systems, according to Forbes. He notes that NIST plays a critical role in advancing the measurement science under these scenarios, both for industry and regulatory stakeholders and aiding in the adoption of new methods and techniques. “Standards enable comparisons, ensure interoperability, and can streamline regulatory review, reducing cost and time,” Forbes says. He points to examples such as the ASTM International F3659-24 Standard Guide for Bioinks Used in Bioprinting,³⁶, reference materials such as the NIST Monoclonal Antibody RM 8671, reference data sets, and interlaboratory studies. “All these components also intertwine into the overall traceability of, and patient confidence in, an individual pharmaceutical dose,” Forbes adds.

What is the state of regulatory guidance for PoC manufacturing?

Little formal guidance exists for decentralized/distributed/PoC manufacturing, and to complicate matters, the guidelines offered have varied between regulatory authorities.¹ The UK’s Medicines and Healthcare products Regulatory Agency has published detailed guidance covering control sites and modular manufacturing pathways.³⁷ The US Food and Drug Administration has not yet issued any formal guidance but did hold a workshop on distributed and point-of-care pharmaceutical manufacturing and subsequently published discussion papers.^38,39 The January 2025 document “Considerations for Complying With 21 CFR 211.110: Guidance for Industry” also includes references to in-process controls for 3D printing and outlines the use of process models, real-time quality monitoring, and innovative sampling strategies for ensuring drug product integrity and batch uniformity when using advanced manufacturing technologies.⁴⁰

In Europe, the European Medicines Agency is including decentralized manufacturing in its multiyear legislative update.¹ Currently, decentralized production sites for a given therapeutic must all be located within the European Union.

What can be expected for PoC manufacturing in the future?

Despite regulatory, quality assurance, and other hurdles (eg, the need for trained workers), Forbes predicts that PoC production will be used in more clinical studies, at hospitals, and by pharmacies, particularly for 3D printing of small-molecule drugs. “As these become more common,” he observes, “health care professionals will begin to incorporate the ability to prescribe more personalized dosing or polypill medications.”

Longer term, Forbes anticipates seeing the impacts of technologies such as artificial intelligence and large language models. “In the case of a decentralized and PoC production paradigm, we might envision a large, interconnected network that can identify local hotspots for the flu, for example, or even anticipate medicinal needs based on usage, past data, and future projections,” he says.

As technologies progress, Forbes suggests the possibility of decentralized networks capable of more basic chemical synthesis and production from raw materials. “The emergency response to new pandemics or the advent of new medicines might be the distribution of recipes,” he notes.

Ultimately, Forbes believes that advancing PoC pharmaceutical manufacturing will require close collaboration among a wide range of stakeholders—including patients, health care providers, drug companies, insurers, and international regulatory agencies—each with distinct requirements. Such collaboration will be essential to fully realize the benefits of bedside drug manufacturing and, more broadly, personalized medicine.

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