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Molly Klote, President and CEO, Klote Medical Research Advisors

 spoke with Dr. Molly Klote, president and CEO, Klote Medical Research Advisors, and moderator of the conference's regulatory track panel, about what the industry must do to navigate a rapidly changing supply chain landscape.

Molly Klote on Reshoring, Tariffs, and the Future of Pharma Supply Chains

PharmTech: What Is Driving the Current Push To Rethink Pharmaceutical Supply Chains?

 The pressure extends well beyond tariffs, though tariffs are clearly part of it. Companies are also responding to geopolitical instability, supplier concentration risks, inspection vulnerabilities, shortage exposure, and deep uncertainty around future policy direction. What I'm hearing from people here at the meeting is that the unpredictability may be as disruptive as the cost itself. Companies need to make long-range manufacturing, sourcing, and regulatory decisions, and they're doing so without knowing which countries will reliably serve as sources or what trade conditions will look like 12 to 24 months from now. That volatility is the core challenge.

For years, the default approach was to source from wherever costs were lowest. That model is no longer sustainable on its own. Companies are now asking how they can build in resilience through dual sourcing, qualified backup suppliers, or greater transparency into their tier-two and tier-three suppliers without restructuring their cost base so dramatically that it compromises affordability or patient access.

Is the Industry Actually Moving Manufacturing Back to the United States?

Not wholesale, and I think it's important to be clear about that. Some selective onshoring is happening, and it makes sense in certain contexts. But the more realistic trend is regionalization combined with supply chain redundancy, building in alternatives rather than relocating everything domestically. Not everything can or should be reshored here. The real work is determining which parts of the supply chain are critical enough to justify higher cost or redundancy and then making those changes in a way that doesn't undermine the affordability and availability of medicines for patients. That balance is difficult, and it requires careful, strategic thinking rather than a reactive response to political pressure.

What Will FDA Be Looking for From Companies as They Adapt Their Supply Chain Strategies?

The FDA is not looking for slogans about resilience. Companies need to be prepared to demonstrate through evidence how they are making resilience a reality. That means having current supply chain maps, formal risk assessments, credible alternate-source strategies, realistic regulatory pathways for supplier or site changes, and governance mechanisms that define when and how the organization responds as risks escalate.

A credible resilience strategy must also be quality-led, not simply procurement-driven. For the FDA, the central question will be whether a company understands its vulnerabilities and has a controlled, documented, and regulatorily realistic plan to protect patients if a supplier, site, country, or logistics route becomes unavailable.

What Regulatory Shifts Should Professionals Expect?

Three things stand out. First, there will be more data-driven FDA oversight of supply chains. The agency wants to see what companies are doing more than what they intend to do. Second, companies should anticipate more risk-based and globally consistent inspection oversight for anything that is globally outsourced. Third, there will be stronger expectations around formal quality risk management. Quality must be built in from the start. The FDA's focus is patient safety, and if your systems are not oriented around that, that is where you will run into serious problems.

What Is Your Overall Message to Companies Navigating This Environment?

Act now and act with specificity. The uncertainty in the current environment is not going away, and the companies that will be best positioned, both commercially and regulatorily, are the ones that treat supply chain resilience as a quality and patient safety imperative, not an external compliance requirement. FDA will reward the companies that can demonstrate they understand their risks and have taken documented, defensible steps to address them.

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Escalating tariffs intersect with geopolitical instability, supplier concentration, inspection vulnerabilities, and drug-shortage exposure to force a rethink of pharma supply chains. Unpredictable policy trajectories are as disruptive as direct cost impacts, complicating 12–24 month manufacturing and sourcing commitments. Rather than broad US reshoring, the dominant response is regionalization plus redundancy, emphasizing dual sourcing and deeper tier-2/3 visibility while preserving affordability and access. FDA expectations are shifting toward evidence-based demonstrations of resilience, quality-led governance, formal risk management, and regulatorily executable pathways for supplier and site changes.

Molly Klote, Klote Medical Research Advisors, discusses how pharma must move beyond tariff-driven reactions to build evidence-based, quality-led supply chain resilience that satisfies FDA scrutiny and protects patient access.

Q&A: Molly Klote on Dual Sourcing, Regionalization, and the New Pharma Normal

CPHI Americas Panel Making the Case for Product Carbon Footprints

Requests for carbon emissions data from customers or procurement teams may have once seemed peripheral to the core business. That is changing rapidly. During a presentation attended by 

, sustainability consultant David Vázquez, climate principal consultant, Nexius Projects, laid out a clear picture of why product carbon footprints (PCFs), the emissions associated with a product across its entire lifecycle, are moving from voluntary best practice to a baseline commercial and regulatory expectation.

The distinction between corporate-level emissions reporting and product-level carbon accounting matters significantly for suppliers in the pharmaceutical value chain, noted Vázquez. Corporate reporting captures the emissions associated with running operations, energy use, fleets, and facilities. A product carbon footprint, by contrast, traces emissions from raw material extraction through to end-of-life waste management. For a packaging supplier to a pharmaceutical manufacturer, for example, that means accounting for every stage from the sourcing of raw materials through to how the packaging is ultimately disposed of. As Vázquez put it during the presentation, “A product carbon footprint helps us to understand the impacts on climate of that specific product and understand exactly at which stage of the value chain the impact is higher, so that we can use them to make decisions."

When a pharmaceutical company has committed to science-based emissions targets or must comply with frameworks such as the European Corporate Sustainability Reporting Directive or California's climate disclosure regulation, the data gaps almost always sit in what is classified as Scope 3, indirect emissions generated across the value chain, including purchased goods and services. 

AstraZeneca's release of a supplier guide in April requiring carbon data from its supply base is one visible example of how this expectation is being operationalized, according to Vázquez. The National Health Service in the UK has similarly introduced supplier emissions reporting requirements, and France is set to implement regulation mandating that companies supplying medicines to hospitals provide detailed, high-quality product carbon footprints. "This is not something that is done just to tick a box," Vázquez noted. "It is something that is currently growing and has large focus from regulators and also from other stakeholders."

Vázquez made the argument that a PCF was not about regulatory obligation, but about operational value. PCFs, when calculated rigorously, function as a diagnostic tool for manufacturing processes. Emissions intensity often tracks closely with process inefficiencies like energy-heavy steps, suboptimal raw material choices, or process routes that have not been scrutinized through a resource lens. Understanding where emissions are concentrated in a production process can surface opportunities to reduce costs and improve yields that might not have been visible through conventional operational review alone. "Something that is sometimes forgotten when we talk about sustainability is that it is not only about climate," Vázquez said. "It is also about being more efficient and reducing costs. That is why product carbon footprints have huge potential; they also uncover inefficiencies that maybe we are not aware of."

This reframing is practically important for professionals tasked with making the internal case for investing in data collection. Approaching operations leadership with a proposal framed around climate action is a harder sell in the current environment than presenting the same exercise as a tool for identifying production inefficiencies, maintaining customer relationships, and keeping pace with regulatory requirements across global markets.

The methodology for calculating PCFs is well-established. Standards including ISO 14067 and the Greenhouse Gas Protocol provide step-by-step guidance, and software tooling has matured considerably. Vázquez’s advice for organizations starting out was to resist the pressure to do everything at once, selecting a single product, defining the appropriate system boundary based on what a specific customer or regulator is asking for, and building from there is a workable approach. Vázquez framed the broader shift as "understanding your product emissions is the next stage in your climate journey. The first stage was understanding your corporate emissions, but now you need to put more emphasis on these things."

The window in which this can be treated as a niche sustainability concern is closing. The organizations building data collection and carbon accounting capabilities now are likely to find themselves better positioned, commercially and operationally, as requirements from both customers and regulators continue to tighten.

Product carbon footprints are rapidly becoming an expected commercial deliverable across the pharma value chain, driven by Scope 3 disclosure mandates and customer procurement requirements. Unlike corporate emissions inventories, PCFs quantify cradle-to-grave impacts and pinpoint value-chain stages driving the largest climate burden. Rigorous PCFs can also function as operational diagnostics, surfacing energy- and material-intense steps that correlate with inefficiency, cost, and yield loss. Mature standards and tools enable phased adoption by piloting one product and fit-for-purpose system boundaries.

Pharmaceutical suppliers face growing pressure to calculate product carbon footprints as customer requirements and global regulations tighten.

CPHI Americas: The Business Case for Product Carbon Footprints in Pharma

Tom Sellig, Adare Pharma Solutions, shares how the CDMO is positioning for growth amid U.S. reshoring and oral dose innovation trends.

Tom Sellig on CDMO Innovation and US Manufacturing Growth

, Tom Sellig, CEO, Adare Pharma Solutions, spoke with 

 to offer his perspective on the forces shaping pharmaceutical development and manufacturing today, from advanced dosage form technologies to the regulatory environment and the industry's reshoring momentum.

Sellig sees the current wave of foreign investment into US manufacturing as a meaningful opportunity for contract development and manufacturing organizations (CDMOs). He says, “as we see companies looking to try to invest in the United States, the opportunity for us is to support these complex formulations that are driving patient needs throughout the world today.”

On the innovation front, Sellig highlights 3D printing of tablets as a consequential growth drivers, enabling differentiated formulation profiles and a broader range of release mechanisms. He also points to solubility and bioavailability enhancement as a crowded but evolving space, suggesting Adare is developing proprietary approaches that could outpace currently available technologies.

Sellig also touches on regulatory dynamics, noting that ongoing changes at the FDA are reshaping how CDMOs and pharma companies collaborate. With priority review vouchers, for example, the agency is placing real pressure on development timelines and demanding faster paths to market.

Workforce development is also an important theme of the discussion as Sellig touches on the launch of the "Adare Academy," an internal training initiative covering both scientific hard skills and professional soft skills, designed to reduce turnover and strengthen client service continuity.

On the broader reshoring narrative, Sellig acknowledges the scale of commitments being made, close to $500 billion pledged by large pharma, while remaining pragmatic. "We're focusing on what we can do today, building out selective capacity and capabilities in order to support the industry's requirements and needs of growth," he says.

Foreign investment and reshoring efforts are creating near-term openings for CDMOs to support increasingly complex formulation work in the United States. Advanced dosage-form innovation is accelerating, with 3D-printed tablets positioned to expand release profiles and product differentiation, while solubility and bioavailability enhancement remains competitive but technically dynamic. Regulatory shifts at FDA are compressing development timelines, with mechanisms such as priority review vouchers intensifying speed-to-market expectations and collaboration demands. Workforce capability is being reinforced through structured internal training to improve retention and ensure continuity in client-facing execution.

Tom Sellig, Adare Pharma Solutions, shares how the CDMO is positioning for growth amid US reshoring and oral dose innovation trends.

At CPHI Americas, Molly Klote, Klote Medical Research Advisors, speaks on how the pharma industry faces tariff volatility and reshoring pressure. She warns FDA wants actionable supply chain plans, not slogans, with quality built in.

, Dr. Molly Klote, president and CEO, Klote Medical Research Advisors, sat down with 

 to share her perspective on the forces reshaping pharma's supply chain strategy and what companies must do to stay ahead of evolving FDA expectations.

On the supply chain front, Klote explains that manufacturers can no longer simply chase the lowest-cost sourcing options. Tariff pressures and domestic reshoring policies are pushing companies to build in redundancy through dual sourcing and other resilience strategies. At the same time, she cautions that a wholesale shift to US-based manufacturing isn't realistic and that getting the cost calculus wrong could ultimately threaten patient access. "Figuring out how they can do that in the most affordable way without changing the cost structure so much that it makes accessibility or availability to patients impossible" is the central tension companies are grappling with, she notes. Klote emphasized that a credible resilience strategy must be quality-led, not simply procurement-driven. For FDA, the question will be whether a company understands its vulnerabilities and has a controlled, documented, and regulatorily realistic plan to protect patients if a supplier, site, country, or logistics route becomes unavailable.

Perhaps more unsettling than the tariffs themselves, however, is the uncertainty surrounding them. Based on her conversations with industry peers at the conference, Klote identifies volatility and unpredictability, not cost alone, as the primary supply chain concern for companies trying to plan long-range.

On the regulatory side, she outlines three trends she expects to define the FDA's posture going forward: more data-driven oversight of supply chains, more risk-based and globally consistent inspection oversight of globally outsourced operations, and stronger requirements for formal quality risk management. Her message to manufacturers is, "The FDA is not looking for slogans from companies. They are looking for actionable plans and what you're doing." Quality, she emphasizes, must be built into systems from the ground up, not bolted on, given the agency's unwavering focus on patient safety.

Pharma supply chains are being reshaped by tariffs, reshoring incentives, and a shift from lowest-cost sourcing toward resilience via redundancy, including dual sourcing. A full pivot to US manufacturing remains impractical, and misjudging the cost equation risks undermining patient access. Greater disruption stems from tariff volatility and planning uncertainty rather than price alone. FDA expectations are trending toward more data-driven supply chain oversight, intensified inspection of globally outsourced operations, and stricter, formalized quality risk management requiring concrete, operational plans with quality embedded by design.

At CPHI Americas, Molly Klote, Klote Medical Research Advisors, spoke about how the pharma industry faces tariff volatility and reshoring pressure. She warned FDA wants actionable supply chain plans, not slogans, with quality built in.

At CPHI Americas, Delaware Gov. Matt Meyer argues domestic pharma manufacturing is a national security priority and positions Delaware as the ideal reshoring hub.

Delaware Governor Meyer on Drug Pricing, Reshoring, and National Security

, Delaware Governor Matt Meyer sat down with 

 to make the case that domestic pharmaceutical manufacturing is far more than an economic issue, it's a matter of national survival. Drawing on lessons from the COVID-19 pandemic, Meyer argues that the US can no longer afford to depend on foreign suppliers for its most critical medicines and medical equipment.

"The manufacturing of the latest, greatest pharmaceutical innovations are not just a matter of economic growth, it's a matter of national security and winning in a global marketplace," Meyer says, framing domestic production as a strategic imperative rather than simply a jobs program.

Meyer points to Delaware's streamlined regulatory environment as a key advantage for pharmaceutical companies looking to bring innovations to market quickly or expand existing facilities. He emphasizes the importance of matching the speed of global commerce, arguing that removing bureaucratic friction is just as valuable as direct investment in new technologies.

On drug pricing and market competition, Meyer strikes a free-market position, supporting competition as the primary mechanism for setting prices, while acknowledging that certain healthcare markets are functionally broken due to overregulation or monopolistic practices. He signals a willingness to intervene at the state level, particularly as federal engagement on those issues has waned.

The COVID pandemic looms large in Meyer's remarks as a turning point in how policymakers think about supply chain vulnerability. "For life-saving medicines, life-saving treatment, life-saving equipment, we need to manufacture it here at home," he states, adding that Delaware is actively positioning itself as the lowest-cost, fastest-to-market destination for companies looking to reshore production.

Delaware Governor Matt Meyer frames domestic pharmaceutical manufacturing as a national security priority intensified by COVID-era supply chain shocks. He argues the US should reduce dependence on foreign sources for essential drugs and medical equipment to safeguard public health and maintain global competitiveness. Delaware is positioned as a rapid, low-friction environment for pharma expansion, leveraging streamlined regulation to accelerate facility buildout and product commercialization. On pricing, Meyer favors competition while conceding some healthcare markets are distorted by overregulation or monopolistic dynamics.

FDA headquarters at White Oak Campus in Silver Spring, Maryland, USA - January 13, 2020. The United States Food and Drug Administration (FDA) is a federal agency. | © JHVEPhoto - stock.adobe.com (330225712)

Richard Pazdur, former director of the FDA's Oncology Center of Excellence, with 26 years of experience at the organization, spoke at a panel during 

 held in Philadelphia from June 2-4. He offered an assessment of where the agency stands today.

Is Regulatory Inconsistency a Systemic Problem?

Pazdur directly stated that inconsistency in the review process is real, and it is tied in part to how applications are evaluated across the lifecycle of a submission. He highlighted the need to revisit Special Protocol Assessments, formal agreements between sponsors and the agency on study design, noting these frameworks, developed more than a decade ago, need modernization. He emphasized that the agency's focus remains on primary endpoints and core statistical principles but acknowledged that inconsistent application of standards remains a challenge the agency must actively address.

Variability in regulatory expectations creates uncertainty in trial design, submission strategy, and timelines. Pazdur advocated for greater use of regulatory plan templates, where sponsors and reviewers work from a shared document, reducing duplicative reporting across review layers. He also pointed to real-time oncology review, where study data are submitted to the agency ahead of the formal application, as a model that can meaningfully compress development timelines.

Advisory committees, he argued, remain essential to transparency and should be strengthened rather than sidelined. He recommended making committee member selection more open and inclusive, involving industry representatives, patient groups, and clinical trialists alongside agency staff. He also called for more focused committee discussions and suggested moving open public hearings to the start of proceedings to improve flow and reduce redundancy.

What Is the Real Impact of Staff Turnover?

Pazdur spoke on how the departure of experienced personnel, including senior scientific and leadership staff, is not simply a numbers problem. It is a quality problem. Complex regulatory decisions require deep scientific expertise, and the loss of institutional knowledge compounds as regulatory challenges grow more sophisticated.

He described a palpable sense of anxiety within the agency’s workforce, noting that scientists with advanced degrees require an environment that supports open exchange of ideas. With acting leadership currently in place across multiple senior positions, the absence of stable direction is a real operational concern. For sponsors navigating submissions, this translates into a less predictable review environment.

Two programs Pazdur championed at the agency illustrate where oncology drug development is heading. Project Optimus challenges the long-standing practice of pushing toward maximum tolerated doses in oncology, arguing that doses patients cannot sustain over time may ultimately undermine clinical outcomes. He acknowledged industry resistance but maintained that dose optimization must be treated as a core development responsibility rather than an afterthought.

Project Orbis, meanwhile, was designed to address the lag in approvals for smaller regulatory markets. By coordinating simultaneous submissions across partner agencies, including those in Canada, Australia, and Switzerland, the program accelerates access to promising therapies globally and promotes consistent standards of care that support more coherent subsequent development.

On the question of Chinese clinical trial data, Pazdur drew a clear line between clinical and manufacturing considerations. He supports incorporating international trial data, including from China, into multi-regional development programs, while separately advocating for domestic onshoring of manufacturing, a distinction he described as both practical and important for US competitiveness. He added that decentralized trials and integration of clinical data into electronic health record systems could dramatically improve trial access and data quality across diverse patient populations.

Richard Pazdur characterized FDA oncology review inconsistency as a persistent, lifecycle-wide issue that affects trial design and submission predictability, while calling for modernization of Special Protocol Assessments and broader use of shared regulatory plan templates. He underscored staff attrition as a loss of institutional scientific judgment compounded by acting leadership and workforce anxiety. He highlighted Project Optimus as a paradigm shift toward dose optimization beyond MTD and Project Orbis as a mechanism to harmonize and accelerate global approvals. He also endorsed using international clinical data while onshoring manufacturing.

FDA instability, staff turnover, and evolving review standards are reshaping drug development. Richard Pazdur, formerly with the FDA, shares what sponsors need to know now.

CPHI Americas: How FDA Instability Is Reshaping Pharmaceutical Development

Stuart Tindal, Sartorius, and David Chau, Thermo Fisher

connected with Stuart Tindal, portfolio manager, Intensified Downstream Systems, Sartorius; and David Chau, global technical product specialist, Thermo Fisher—both Bio-Process Systems Alliance committee leaders—discuss automation, single-use technology challenges, and smarter process control in bioprocessing.

Watch the 2-part video interview with Tindal and Chau:
Part 1: 

How Predictive Control Is Reshaping Continuous Bioprocessing

Stuart Tindal and David Chau on Sensors, Standards, and Shared Progress

PT: How Should Companies Think About Integrating Automation into Continuous Bioprocessing?

 Automation isn't optional anymore, it's an integral part of any continuous or advanced bioprocessing operation. The industry has moved decisively away from purely manual operations. As processes have become more data-driven and connectivity has increased, the need for robust control and automation has become paramount. It's no longer a nice-to-have; it's a must-have for maintaining consistency and productivity.

 The foundation must be process understanding. Before you can automate anything, you need to know what you're trying to make continuous. You must consider what the inputs and outputs are, what parameters matter, how you'll measure them through sensors or equipment. People entering continuous bioprocessing right now can feel overwhelmed, whether they're building a process from scratch or retrofitting an existing one. Going back to the fundamentals of your process is often the most valuable first step.

How Do Single-Use Technologies Fit in with the Demands of Continuous Manufacturing?

 It's a real tension. Single-use technology has earned its place in the industry with faster turnaround times, flexibility, speed at the R&D and pilot scale. But those same benefits can become concerns when you're talking about commercial-scale continuous manufacturing, where processes run for weeks or even months. Single-use was designed to be limited. As an industry, vendors and end users must come together to honestly assess the limitations and innovate around them.

 It comes down to the materials of construction. When something is designed for a single day of use and you're asking it to perform for weeks, critical failure points emerge. Are the sensors drifting over time? Are the actuators, the pumps and valves moving plastic components, going to withstand prolonged friction and wear? The work being done now is about understanding how far these materials can be pushed and what alternatives or design changes can support longer continuous runs.

What Does the Future of Process Control Look Like in Continuous Bioprocessing?

 We're moving beyond conventional PID controllers toward predictive and model-based control. In a continuous process, your operating window becomes more of a tunnel, you need to steer the process along that tunnel in real time, being adaptive and anticipatory. That requires a very fast control and response loop. For more complex or labile molecules with tighter critical quality attributes, advanced predictive control isn't a luxury, it's what enables you to maintain the process trajectory from start to finish.

 Continuous manufacturing generates enormous amounts of data, and the question becomes what we do with it. Model-based approaches make a lot of sense in this context; with enough data, you can build predictive models that guide processes rather than simply hold set points. The shift is from reactive control to genuinely steering and predicting where your process is headed. That's where the industry is going, and it's an exciting direction.

Automation is now foundational to continuous and advanced bioprocessing, driven by increased connectivity and data-centric operations requiring robust control to maintain consistency and productivity. Effective implementation starts with deep process understanding—defining critical inputs, outputs, and measurable parameters—especially when retrofitting legacy operations. Single-use systems offer flexibility and rapid changeover, yet commercial continuous runs expose durability limits in materials, sensors, pumps, and valves. Process control is shifting from PID to predictive, model-based strategies that use high-frequency feedback and large datasets to steer processes within tight operating windows.

Stuart Tindal, Sartorius, and David Chau, Thermo Fisher, discuss automation, single-use technology limits, and predictive control shaping continuous bioprocessing's future.

Q&A: How Continuous Bioprocessing Is Evolving With Smarter Automation

sat down with Bryan Poltilove, strategic advisor and independent board director focused on bioprocessing and advanced therapy manufacturing, to discuss how just-in-time, point-of-care manufacturing is revolutionizing biopharma without compromising quality.

Watch the 2-part video interview with Poltilove:
Part 1: 

Bryan Poltilove on Evolving Bioprocessing Manufacturing Paradigms

Point-of-Use Media Manufacturing Could Cut Bioprocessing's Carbon Footprint by Two Thirds

What's Changing in Bioprocessing and Advanced Therapy Manufacturing and What Is Staying the Same?

The fundamentals aren't going anywhere, validation and GMP manufacturing. Nobody's willing to take risks there, nor should they be. The industry standard is well established and well understood.

What is changing is how and where manufacturing happens. We're seeing a significant shift toward point-of-care and place-of-care models, more distributed approaches to manufacturing, and supply chains that are becoming increasingly flexible in how reagents and other products are delivered to the industry. Cost has always mattered, but now environmental sustainability and supply chain resilience are becoming equally important drivers of that change.

It's a genuine paradigm change, a change in mentality and approach, not just a tweak to existing processes. The best analogy I can offer is the auto industry in the 1980s moving from large, inventory-heavy operations to just-in-time manufacturing. Biopharma is undergoing something very similar right now.

The key challenge is achieving that flexibility without compromising on the things that cannot be compromised. Reproducibility, availability, quality standards, those are non-negotiable. The goal is to find technologies and supply chain approaches that reduce inventory, make logistics more seamless, and give manufacturers more operational flexibility, all while keeping the product and the regulatory standards fully protected.

Where Are You Seeing this Play Out Most Concretely?

Cell therapy is probably the clearest example. We're seeing modular clean rooms, new cell processing technologies, and unit operations that can realistically be executed in a hospital setting. It's a remarkable development when you think about where cell therapy manufacturing stood even a decade ago.

I'm currently working with Nucleus Biologics, which has a particularly innovative approach to media manufacturing. The model is almost like a Nespresso or Keurig concept for cell culture media. Rather than producing a large, centralized batch and distributing it broadly, you're enabling on-demand, point-of-use manufacturing of the media itself. Their Krakatoa technology is built around that idea, storing powders on-site and only requiring water on-demand, rather than shipping and storing large volumes of liquid media.

What's the Practical Significance of that Powder-Based, On-Demand Approach?

The potential is substantial. Shipping requirements drop considerably because you're moving powder rather than liquid, and storage needs on-site shrink accordingly. Beyond the logistics, you gain the ability to manufacture exactly when and what you need, no excess, no waste.

What makes it compelling is that it combines the best of both existing formats: the ease of use and flexibility of liquid media with the logistical and cost advantages of powder. Bringing those two things together in a single workflow is genuinely innovative.

How Significant Is the Environmental Sustainability of this Shift?

It's increasingly central to how the industry evaluates these decisions. Best-in-class sustainability thinking now looks at total environmental impact from sourcing all the way through disposal, not just what comes out of a single step in the process.

Based on figures I've seen, moving to a distributed, point-of-use model for cell culture products can reduce end-to-end carbon footprint by roughly two-thirds compared to traditional centralized manufacturing. There's enormous promise here, or the industry and for the world more broadly.

It's just getting off the ground. A prototype system has been deployed in academic and industrial labs across multiple continents, used hundreds if not thousands of times, and has demonstrated strong reproducibility, consistency, and reliability at that scale. The commercial launch is happening now. Scaling that performance up to full bioprocessing scale is the next step, and I have every reason to believe the results will follow the same trajectory.

Validation and GMP rigor remain non-negotiable in bioprocessing, but manufacturing paradigms are shifting toward distributed, point-of-care/place-of-care models that prioritize flexibility, resilience, and sustainability alongside cost. This represents a just-in-time mindset change analogous to automotive manufacturing’s 1980s evolution, requiring inventory reduction without sacrificing reproducibility or quality. Cell therapy is the clearest near-term proving ground, enabled by modular clean rooms and hospital-executable unit operations. Powder-based, on-demand media manufacturing could materially reduce logistics burden, waste, and end-to-end carbon footprint.

Bryan Poltilove discusses how distributed, point-of-care manufacturing is reshaping biopharma supply chains and cutting carbon footprints.

Q&A: Bryan Poltilove on the Future of Bioprocessing

George Kwiecinski, Global Key Solutions Corp

connected with George Kwiecinski, CEO and co-founder of Global Key Solutions Corp, to discuss FDA GMP inspection trends, supplier oversight gaps, and the rising regulatory scrutiny of AI in pharma compliance.

Watch the full video interview with George Kwiecinski:


George Kwiecinski on Why Now Is the Time to Reassess Your GMP Audit Strategy

PT: How Should Quality and Compliance Teams Prioritize Foreign Suppliers for Audit or Reinspection when Inspection Coverage Is Limited?

Kwiecinski: It comes down to resources and organizational capacity. Whether you're inspecting an internal facility or auditing a supplier, most organizations are working within real constraints. The question becomes: are you procuring the right tools and technology to make sound assessments? Are you selecting suppliers through a documented, demonstrable process? These aren't just best practices, they're expectations. With the QMSR changes affecting both medical devices and the FDA's ability to scrutinize internal audit documentation, this has become a hot-button issue. Organizations need to take a second look at how those processes are being handled and reprioritize accordingly. The good news is that tech stacks have improved significantly for most workflows, so there's really no excuse not to reassess.

What's Your Outlook on Compliance Risk in Global Supply Chains?

Honestly, I don't think the fundamental risk picture changes dramatically. The top citation areas will continue to revolve around the quality unit, drug efficacy and safety standards, and how those standards are being enforced across vendors. Those core pillars aren't going anywhere. What will shift is the context around them, especially as new technologies and practices become more common in the industry.

How can AI-powered Regulatory Intelligence Improve Oversight without Providing False Positives or Incomplete Data?

Yes, this is something we've been tracking closely. One trend that really made waves recently was that an AI citation appearing in an FDA warning letter. Essentially, a company had used AI to respond to the FDA and generate some of their documentation, and that usage was called out directly. Now, I think this kind of citation will become more frequent over time. It may not always be flagged explicitly, but AI use in regulatory processes is clearly on the FDA's radar.

We put together a white paper recently looking at how the FDA has used ‘AI’ as a keyword across its correspondence and documentation over the last 3-4 years. What we found was telling: there are now 5 distinct regulatory correspondences specifically referencing AI, and over 20 FDA guidance and documents that mention it, with the frequency increasing steadily over time. That trajectory tells us that AI is becoming a meaningful part of the agency's regulatory purview, and companies need to start thinking about what that means for them.

What Changes Do You Recommend to Strengthen Foreign Supplier Governance when API and Finished-dose Sourcing Is Heavily Concentrated Overseas?

The first step is just awareness, understanding that these changes are happening and that it's accelerating. From there, it's about looking at your own tech stack and honestly evaluating how your organization is managing AI-related risk. If your organization is using AI tools in any part of its regulatory or quality workflow, you need to be thoughtful about how those decisions are documented and defended.

As for whether companies should invest in new AI tools, I think that's a legitimate conversation to have, but the justification has to be grounded in business reality. If a tool can demonstrably save cost or drive profit, and you can implement it in a safe, controlled way, then pursuing it makes sense. What's going to matter most though, is the risk-based approach: how are you accounting for AI-assisted or AI-driven decisions within your processes? That's exactly the kind of thing that's subject to FDA scrutiny right now.

Global supplier oversight remains constrained by finite audit resources, elevating the importance of documented, defensible risk prioritization and fit-for-purpose technology. Persistent GMP citation drivers—quality unit effectiveness and enforcement of efficacy/safety standards across vendors—are expected to continue, but will be reframed by expanding use of AI in quality and regulatory workflows. FDA attention to AI is increasing, including explicit mention in warning-letter context and growing references across agency correspondences and guidances. Organizations should reassess audit strategies, strengthen governance of overseas sourcing, and formalize controls for AI-assisted decisions.

George Kwiecinski, Global Key Solutions Corp, breaks down GMP inspection risks, global supply chain compliance, and AI's growing role in FDA regulatory scrutiny.

Q&A: George Kwiecinski on How AI Is Reshaping FDA Regulatory Compliance

sat down with Ryan Kelly, interim CEO and senior director of Supply Chain Security and Brand Protection, Rx360, to explain why true supply chain visibility, smarter auditing, and quality alignment are critical to protecting patients.

Watch the 2-part video interview with Kelly:
Part 1: 

Ryan Kelly on Smarter Pharma Supply Chain Audits

Ryan Kelly's Tips for Drug Supply Chain Protection

PT: What Is the Impact of Third-Party Audits?

Kelly: The results have been significant. We have case studies where we've saved millions of dollars simply by catching issues early. There's also a compounding benefit, when third-party audits are done well, they can reduce how frequently a company needs to be audited at all. That's a win on both sides. The supplier isn't constantly hosting audit teams, and the company doing the auditing saves on cost and resources. It becomes cheaper, more efficient, and more effective for everyone involved.

The reality is you can't audit everything. It comes down to risk stratification, focusing your most intensive scrutiny on the most critical areas, and using the third-party model to provide a right-sized level of assurance for areas that are lower risk. The goal is coverage without overkill.

What Is Changing About the Intersection of Quality and Supply Chain?

Historically, quality owned the manufacturing process, batch release, process controls. Supply chain focused on execution, coordination, and moving product. Those were largely siloed functions. At Rx360, we're actively working to break down that divide, because the truth is they are inseparable. How you move product through the supply chain, maintaining temperature, visibility, and control at every stage, directly impacts quality. We have to look at GMP and GDP holistically and build quality into supply chain design from the very beginning, not add it as an afterthought.

The most effective way to drive alignment is to work backwards from the patient. If every decision ties back to ensuring the patient receives a safe and efficacious dose, quality and supply chain teams naturally find shared purpose.

What Are the Most Common Mistakes You See Organizations Making?

One big mistake I see is a false sense of supply redundancy. A company will identify a primary supplier and a secondary supplier and feel confident they're protected. But when you dig deeper, you often find that the secondary supplier is sourcing their raw materials from the same place as the primary supplier. So if there's a supply disruption at that source, there is no reliable backup in your supply chain.

That's why supply chain mapping is so essential. You need to understand every single product, its full end-to-end flow, where your inventory sits at every node, and what could go wrong at each point. That includes geographic, regional, transportation, and financial risks within your supply base. It sounds straightforward, but many organizations genuinely don't have complete visibility into where their physical product is at any given time, from raw materials and APIs all the way through to final labeling and delivery to the customer.

In order to address these gaps organizations need to digitize where they can, audit against the highest international standards regardless of where you're operating, and build quality into your workflows from the start. You simply cannot add quality at the end. The organizations that understand that are the ones that will protect both their supply chain and their patients.

Third-party auditing, when executed rigorously, can generate material cost savings by identifying issues early and can reduce redundant audit burden across suppliers and sponsors. Because comprehensive auditing is impossible, risk stratification is required to match assurance levels to criticality. Quality and supply chain can no longer operate as silos; GMP and GDP are operationally inseparable, and quality must be engineered into supply chain design rather than appended at release. Common vulnerabilities include illusory redundancy and limited end-to-end visibility, underscoring the need for mapping, digitization, and global standards.

Ryan Kelly, Rx360, shares how aligning quality, supply chain functions, and auditing deeper is key to pharmaceutical patient safety.

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