A key priority for the current US administration is strengthening domestic pharmaceutical manufacturing to reduce reliance on foreign sources of critical medicines. Persistent drug shortages—driven by low margins, complex manufacturing processes, and quality, among other factors—have underscored vulnerabilities in the global supply chain. More than 80 percent of the active pharmaceutical ingredients (APIs) and key starting materials (KSMs) used in US drugs come from China, India, and the EU, creating both national and health security risks. Generic medicines, which account for approximately 90 percent of all US prescriptions, are most affected by these shortages.
For lab managers, these shifts have direct implications for how and where to invest. In response to national security concerns, public health priorities, and new tariffs and incentives, many organizations are expanding or modernizing facilities, adopting advanced technologies, and integrating automation and AI/ML to improve efficiency. Lab leaders must now weigh decisions around long-term cost savings, speed to market, scalability, and sustainability. Labs must also attract, train, and retain a skilled workforce aligned with quality and regulatory requirements.
These choices set the stage for how laboratories will adapt and compete as new technologies and business drivers redefine pharmaceutical development and production.
Technology investments transforming pharmaceutical labs
Advanced manufacturing technologies: Many laboratories are leveraging AI and ML, from discovery through production, and are employing advanced manufacturing technologies such as 3-D printing, continuous flow, process analytical technologies (PAT), biotechnology, and the development of new synthetic routes that may be more efficient and sustainable.
In June 2025, US Pharmacopeia (USP) opened an Advanced Technologies Laboratory to support and accelerate the adoption of newer technologies that may be used to produce and analyze quality medicines.
According to Dennis Hall, VP of advanced manufacturing technologies at USP, one focus is expanding the use of flow chemistry in pharmaceuticals to replace slower, batch-based synthesis. Andy Carpenter, chief scientific officer at Phlow, adds that continuous flow can eliminate unnecessary unit operations and improve manufacturing efficiency when combined with PAT tools and automated reaction design.
New processes for manufacturing APIs and KSMs have also been developed by innovative companies such as Antheia, Capra Biosciences, and Ginkgo Bioworks. Using bio-derived starting materials, bioengineering, and bioprocessing, these organizations are creating efficient and scalable routes for API and KSM production.
Advanced modeling software and process automation, medium- and high-throughput robotics, and multi-unit operations can add efficiencies, along with data-driven optimization and data analytics to inform and accelerate drug development and manufacturing. AI can be leveraged to design new synthetic routes and increase efficiency, quality, and real-time monitoring/real-time release, according to Ryan Littich, chief technology officer at the Medicines for All Institute. “The use of AI as an enabling technology for solving problems at lower costs offers an extra set of hands to enhance current talent. Robotics can be effectively applied, especially based on the complexity of molecules (e.g., higher molecular weight, sophisticated scaffolds, chiral compounds) and for more complex projects.”
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Power of collaboration: Public-private partnerships—such as those led by the US Pharmacopeia (USP), the API Innovation Center, and the BioMaP Consortium—are helping labs coordinate and access shared infrastructure, training, and technical expertise. Federal programs from agencies including the FDA, ASPR, DoW, ARPA-H, EDA, and the NSF are also funding initiatives that advance domestic manufacturing and workforce development through regional innovation hubs. These regional efforts are creating ecosystems that drive innovation and growth.
For lab leaders, these collaborations create opportunities to pilot new technologies, access specialized capabilities, and build talent pipelines. Engaging with academic partners, CDMOs, and government-backed programs can help labs expand capacity, validate new methods, and position themselves for future growth.
Practical considerations: For expanding pharma laboratories and CDMOs, there are a variety of important decisions to consider:
Lab readiness
- Will new equipment need to be purchased to accommodate additional capacity? Is this a good time to evaluate newer technologies, both for manufacturing and for analytical QC? Can current regulatory systems accommodate new technologies, and how will compliance and quality systems need to be adapted?
- As new technologies are introduced, it’s critical to understand future maintenance support from the supplier with respect to current technologies and how long current platforms will be supported.
- Is leasing equipment a viable option for short-term projects, or if technology rapidly advancing? Often, leases will include service coverage, so the ROI of lease vs. buy decisions can be calculated based on anticipated lifetime, current cashflow considerations, and depreciation schedules.
- Are there incentives for adding new technologies? Tax incentives or accelerated regulatory pathways (e.g., via the FDA FRAME program with goals to modernize drug production and improve supply chains) may facilitate the adoption of newer technologies.
- Flexibility and scalability for future growth are key in adding equipment. Modular solutions that can be repurposed or used for multiple projects/ products are important for maximum instrument utilization.
Planning, sourcing, and collaboration
- Early planning and engagement (both internally and externally) with facilities, QA/regulatory, EHS, suppliers, and procurement teams are key for site preparation and meeting required timelines.
- Will multi-year supplier agreements yield greater discounts and savings? What is the turnaround time for delivery and installation? Have alternative suppliers been identified and contacted to ensure continued supply? Do vendor audits need to be scheduled? Have the required software platforms and applications been reviewed and approved by IT and regulatory teams to reside on internal networks?
- Are there project partners that can be identified early on that provide complementary expertise/capacity (upstream or downstream capabilities) for joint investment? Very often, CDMOs and universities can provide additional capabilities, capacity, or specialty services for faster start up.
Data management tools and compliance
With new instruments, software systems, operating systems, and validated solutions are critical for data acquisition, analysis, storage, and archival. Platforms such as ELN, SDMS, LIMS, and cloud-based solutions should be reviewed with all suppliers, as well as IT and regulatory, to plan and align early on specific applications that control systems and acquire data. Qualification and validation of these systems in a seamless fashion, with SOPs established by the lab and QA personnel, should be planned and coordinated with any new equipment acquisitions. Data integration among different software platforms is an important consideration for decision-making, compliance, and easy retrieval of results.
Data sharing capabilities are also important, especially among collaborators and CDMOs with their sponsors, while ensuring data integrity and protection of intellectual property. Cloud labs and secured open-access platforms are examples of how results can be shared while maintaining system security.
Adoption of digital and AI tools
This is probably one of the fastest-growing areas, with the importance of automation and AI-driven tools to improve and optimize processes throughout the drug development and manufacturing lifecycle. These enhancements can inform discovery, development, and production, including new synthetic routes, predictive analytics, modeling software, intelligent maintenance platforms with automated troubleshooting, feedback, and usage metrics, automated method validation software, process analytical technologies with the potential for real-time release testing, and the use of digital twins for QC optimization via sensors and simulations.
Building and retaining a strong workforce
Talent is one of the most valuable resources of an organization; thus, investment in training and employee development is important in attracting and retaining talent. Especially with advanced technologies and platforms, skill-based competencies and expertise are a competitive advantage for any organization. Some resources and best practices include:
- Continued training and skill development, as well as ensuring there is a career path for employee advancement
- Working closely with local universities and community colleges to identify and attract talent, participate in career days, and partner on continuing education or online training programs for employees. Attending local meetings, professional societies, discussion groups, and conferences, where applicable
- Mentoring and cross-training programs within the organization
- Practical hands-on training opportunities, as well as the use of online and virtual reality platforms
- Skill-based learning via micro-credential programs and digital badges for specific laboratory competencies
Preparing for the future of pharmaceutical production
The renewed focus on domestic pharmaceutical manufacturing gives labs a clear mandate: modernize, collaborate, and invest in the systems and people that ensure quality and resilience. Lab leaders who align technology adoption with workforce development and strong partnerships will be best positioned to sustainably drive efficiency, compliance, and innovation in the next era of drug production.
