Archive for category: Special Report

The COVID-19 pandemic and global disruptions have exposed the vulnerabilities of pharmaceutical supply chains that rely heavily on overseas manufacturing. In response, many in the industry and government are exploring nearshoring – shifting production closer to the U.S. – to reduce dependence on countries like China and India. This section examines the trend toward nearshoring in pharma, government incentives and cost factors, challenges to implementation, and case studies illustrating efforts to localize production.

Shifting Production Closer to Home

For decades, American pharmaceutical companies have offshored manufacturing of active pharmaceutical ingredients (APIs) and generic drugs to lower-cost countries. As a result, the U.S. today depends on just a few countries for the majority of its drug supply. Over 60% of APIs for U.S. medicines come from India and China, with India alone supplying nearly half​ (wilsoncenter.org). Overall, an estimated 77% of key pharmaceutical ingredients used in the U.S. are sourced overseas, including a significant share from China​ (smith.senate.gov). This concentration has created critical choke points: if a single foreign plant shuts down or if geopolitical tensions rise, U.S. hospitals and patients can face drug shortages.

Recent health crises have highlighted these risks. The pandemic, along with other disruptions, “awakened the pharma industry to the dangers of relying too heavily on suppliers located thousands of miles away”​ (fullavantenews.com). There is growing consensus that diversifying and regionalizing the supply base is crucial for national health security. Nearshoring – moving manufacturing to the U.S. or nearby countries – is seen as a solution to shorten supply lines and gain more control. For example, Puerto Rico (a U.S. territory) is re-emerging as a pharma manufacturing hub with strong federal support, and as of 2020, 12 of the 20 largest drugmakers have operations on the island​ (sdcexec.com). Likewise, partnerships with Mexico are being considered, taking advantage of existing industrial capacity and proximity​ (wilsoncenter.org).

Government Incentives and Cost Considerations

Rebuilding pharmaceutical production domestically or in friendly nearby nations requires significant investment and policy support. To encourage nearshoring, the U.S. government has introduced or proposed several incentives:

• Tax Advantages: The federal government and some states offer tax credits to firms that manufacture medical products in the U.S. For instance, the Domestic Medical and Drug Production tax credit effectively halves the corporate tax rate on income from domestic drug manufacturing​ (wilsoncenter.org). Industry groups like PhRMA have even lobbied for CHIPS Act-style tax credits (around 25%) for pharmaceutical manufacturing investments​ (fiercepharma.com).
• Grants and Contracts: Using funding mechanisms like the Defense Production Act, authorities have directly invested in onshoring critical drug production. In one example, the Department of Defense committed $1 billion over 5 years to boost domestic biomanufacturing infrastructure​ (sdcexec.com). During the pandemic, the government also awarded contracts to build U.S. API manufacturing capacity for essential generics.
• “Buy American” Preferences: Proposed legislation such as the bipartisan American Made Pharmaceuticals Act aims to prioritize U.S.-made drugs in federal healthcare programs​ (smith.senate.gov). This would reward manufacturers of critical medicines who produce domestically by giving them preferred status in Medicare/Medicaid formularies and reimbursement​ (smith.senate.gov).
• Streamlined Regulation: Policymakers recognize that lengthy approval processes and complex regulations can deter domestic plant construction. Recommendations have been made to streamline facility approvals and inspections without compromising safety, in order to shorten the time to stand up new production lines​ (wilsoncenter.org).

Despite these incentives, cost remains a central consideration. Manufacturing pharmaceuticals in the U.S. or even in closer countries like Mexico often carries higher labor and overhead costs than in India or China. The price gap has narrowed with automation, but it still exists. One analysis noted that shifting production to North America could be more costly, so incentives or higher reimbursements for U.S.-made drugs may be needed to make nearshoring economically viable​ (wilsoncenter.org). Additionally, building new facilities is capital-intensive and time-consuming – it can take several years and hundreds of millions of dollars to get a pharmaceutical plant operational.

Case studies show both the promise and challenges of nearshoring. Generic drug maker Amneal Pharmaceuticals has publicly supported efforts to reshore production, stating that a resilient supply chain “lies within our nation” and highlighting the company’s investments in U.S. manufacturing​ (smith.senate.gov). Another example is India’s response: India itself depends on China for up to 90% of certain drug ingredients, and in 2020 it launched a $1.3 billion Production-Linked Incentive program to boost domestic API manufacturing​ csis.org (wilsoncenter.org). This underscores that multiple countries are now incentivizing local production, and the U.S. must remain competitive in attracting pharma manufacturing.

Challenges to Implementation

While the trend is toward more regionalized pharma supply chains, significant challenges must be navigated:

• Limited Short-Term Feasibility: It is unrealistic to expect a rapid overhaul of global supply lines. Experts caution that fully replacing Chinese and Indian production is not possible in the short or medium term​ (wilsoncenter.org). Those countries have enormous capacity and well-established supply ecosystems. Nearshoring will be a gradual process, initially targeting select products (especially essential generics and APIs prone to shortage).
• Capacity and Infrastructure: The U.S. and neighbors will need to build or repurpose manufacturing facilities at scale. There is also a shortage of skilled chemical and bioprocess engineers and workers in the domestic workforce, which could bottleneck new projects. Partnering with experienced international firms or training programs may be necessary to staff new plants.
• Supply Chain Complexity: Simply moving final drug production to the U.S. doesn’t eliminate global dependence if raw materials and precursors still come from abroad. True supply chain resiliency requires mapping and securing sources of key starting materials (KSMs) and precursors, many of which are currently only made in China​ (wilsoncenter.org). Without a holistic approach, the locus of dependence could shift to a single domestic facility, which is “no more advisable” for security than a single foreign source (wilsoncenter.org).
• Regulatory and Quality Challenges: Manufacturers must meet stringent FDA standards. Some foreign API producers have struggled with quality issues (for example, in 2022 an Indian company had to suspend imports after an FDA warning letter)​ (csis.org). As production moves closer, maintaining high quality and GMP compliance will be essential to avoid shortages due to regulatory enforcement.

Despite these hurdles, the momentum for nearshoring is strong. The lessons of COVID-19 and recent drug shortages have galvanized stakeholders to prioritize supply chain resiliency. A diversified, geographically dispersed manufacturing base – including facilities in the U.S., Puerto Rico, Mexico, and other allied nations – is viewed as a strategic imperative for healthcare security. As one logistics executive observed, global chains “choked” during the pandemic, and diversified sourcing and nearshoring are considered the best options going forward​ (pharmaceuticalcommerce.com).

Industry Outlook

In the coming years, we can expect continued public-private collaboration to build redundancy into pharma supply lines. Key essential medicines and ingredients may see domestic production increases supported by government purchasing agreements (guaranteeing a market for U.S.-made drugs). Manufacturers will likely adopt advanced technologies (e.g., continuous manufacturing, automation) to make local production more cost-competitive with overseas plants​ (pharmaceuticalcommerce.com). Nearshoring is not a silver bullet – overseas partners will remain important – but it can significantly reduce the risk of supply disruptions for critical therapies.

Conclusion

The push for nearshoring in pharmaceutical supply chains represents a shift from just-in-time globalization to a more secure and resilient model. By leveraging incentives and learning from case studies, the U.S. has an opportunity to strengthen its drug supply while still collaborating globally. Companies that proactively explore regional manufacturing and supply diversification will be better positioned against future shocks.

Euro-American Worldwide Logistics is ready to assist pharma and biotech firms in this transition. From setting up efficient distribution networks in North America to managing cross-border logistics with Mexico and Puerto Rico, our expertise can help realize nearshoring benefits without interrupting supply. Contact Euro-American Worldwide Logistics to learn how we can bolster your pharma supply chain resilience through smart nearshoring strategies.

References

Rudman, A. I. & Haar, J. (2024, June). Strengthening US-Mexico Quality Pharmaceutical Supply Chains. Wilson Center – Wahba Institute.
wilsoncenter.org
​
U.S. Senator Tina Smith. (2023, Nov 15). Press Release: American Made Pharmaceuticals Act Would Reduce Dependence on Foreign Manufacturing.
smith.senate.gov
​
Council on Strategic Risks (Andrew Rudman). (2024, Nov 18). A Bilateral Approach to Address Vulnerability in the Pharmaceutical Supply Chain. CSIS Commentary.
csis.org

Spencer-Jolliffe, N. (2024, Oct 28). Preparing for DSCSA Transition with Tech-Led Compliance (interview with Bandy). Pharmaceutical Technology. (nearshoring quote)
pharmaceuticalcommerce.com

SDC Executive (EPAM Systems). (2023, Nov 7). U.S. Government is Looking to Bring Biotech Manufacturing Back Home.
sdcexec.com
​
AutoStore. (2025, Mar 4). 5 Challenges for 3PLs in 2025. (Trade tariffs and nearshoring)
autostoresystem.com

In the pharmaceutical and biotech industries, maintaining product quality isn’t just about how drugs are manufactured – it’s equally about how they are stored and shipped. Many of today’s medicines, especially biologics, vaccines, and cell/gene therapies, are sensitive to environmental conditions. Any deviation from required storage temperatures or handling procedures can degrade a drug’s efficacy or safety. To prevent such outcomes, companies follow cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) guidelines rigorously in their logistics operations. This section explores best practices for ensuring storage and transportation meet these high standards, particularly for temperature-sensitive products, often referred to as the cold chain.

The Importance of cGMP and GDP in Logistics

cGMP guidelines enforced by regulators like FDA and EMA ensure that pharmaceutical products are consistently produced and controlled to quality standards. While cGMP mainly focuses on manufacturing processes, its principles extend to storage and distribution. Facilities that hold pharmaceutical inventory should be considered an extension of the manufacturing process in terms of quality control. Meanwhile, GDP (Good Distribution Practice) provides specific guidance on proper distribution. GDP describes the minimum standards a wholesale distributor must meet to ensure the quality and integrity of medicines is maintained throughout the supply chain​ (ema.europa.eu). In the EU, GDP compliance is legally required for distributors, and inspectors check that medicines are stored and transported correctly, contamination is avoided, stock is rotated, and products reach the right destination on time​ (ema.europa.eu).

Why all this rigor? Consider that a vaccine made under pristine GMP conditions can become useless if it’s later shipped through a “dirty, uncontrolled supply chain” – exposed to heat or mishandled – by the time it reaches a patient​ (qualio.com). To avoid this, companies implement quality management in warehousing and transit, not just in production. Following cGMP/GDP best practices reduces the risk of temperature excursions, contamination, product mix-ups, and delays, all of which can have patient safety implications and cost companies millions in losses or recalls.

cGMP-Compliant Storage: Key Practices

1. Qualified Facilities and Equipment: Warehouses for pharmaceuticals must be designed and qualified for proper storage conditions. This includes having temperature-controlled zones (for example, 2°C–8°C cold rooms, -20°C freezers, or even -80°C ultra-low freezers and liquid nitrogen tanks for certain biologics​ (dicksondata.com). HVAC systems should maintain controlled ambient conditions for drugs that are stable at room temperature (often 15°C–25°C with humidity control). All storage equipment should go through IQ/OQ/PQ (Installation/Operational/Performance Qualification) to ensure they consistently hold the required temperature range.
2. Monitoring and Alarms: Continuous environmental monitoring systems are essential. Temperature (and humidity where relevant) should be tracked 24/7 using calibrated probes. If readings drift out of range, automated alarms must alert staff immediately. Modern systems can send alerts via phone/email and even have backup notification chains. Additionally, having redundant sensors and periodic calibration ensures accuracy. For critical products, some companies use dual monitoring: the facility’s system plus a data logger that travels with the product, to double-confirm conditions.
3. Controlled Access and Organization: cGMP storage requires controlled access to prevent mix-ups or tampering. Only authorized, trained personnel should handle pharmaceutical inventory. Within the storage area, products are segregated by status (released vs. quarantined stock), and look-alike or sound-alike products are stored separately to avoid confusion. A good practice is to clearly label areas and shelves, and use barcoding systems to track locations of each batch. This also helps maintain FEFO (First-Expire, First-Out) inventory management, meaning the items with the nearest expiration dates are dispatched first to avoid waste​ (ema.europa.eu).
4. Cleaning and Contamination Control: The warehouse should follow sanitation SOPs – regular cleaning schedules, pest control, and avoidance of any food/drink or other materials that could contaminate medicines. Even though products are sealed, cGMP expects warehouses to keep an environment that wouldn’t introduce contaminants if a package were compromised. Separate storage for chemicals or anything with strong odors is important so they don’t permeate packaging.
5. Backup Systems: Power failures or equipment breakdowns can be disastrous for cold storage. Backup generators capable of maintaining freezers and cold rooms are a must. Also, having backup freezers or space in alternate locations can save valuable product in an emergency. Many companies conduct drills (e.g., what to do if a freezer fails – how to transfer product to backup storage quickly). Contingency planning is part of GMP/GDP expectations.
6. Documentation: Every aspect of storage – temperature logs, cleaning records, alarm incident reports, personnel training records – should be documented. This not only satisfies compliance during audits, but also helps investigate any deviations thoroughly.

Temperature-Sensitive Shipping (Cold Chain) Best Practices

Managing the cold chain is arguably one of the toughest logistics challenges in pharma. Nearly half of new pharmaceuticals are temperature-sensitive, and by value, cold chain products made up over 26% of the market in 2019, a share that continues to grow​ (dicksondata.com). Moreover, if the cold chain fails, products can spoil: industry research found the pharmaceutical sector loses about $35 billion annually due to temperature excursions and other lapses in cold chain management​ (dicksondata.com). Here are best practices to prevent such losses:

1. Validated Packaging Solutions: Use qualified insulated shippers or active temperature-controlled containers appropriate for the product’s needs. For short shipments, passive coolers with gel packs or dry ice (for frozen goods) are common – these should be tested to maintain required temperatures for longer than the maximum transit time, accounting for possible delays. For high-value or longer shipments, active containers (electric refrigerating units, or liquid nitrogen dry vapor shippers for ultra-cold) may be used. Always follow the packaging manufacturer’s instructions for conditioning (pre-cooling packs, etc.) and packing configuration. Reusable container options can also be considered for cost and sustainability benefits, as long as they are properly checked and refurbished each cycle.
2. Route Planning and Speed: Minimize transit time and handoffs. The more transfers or stops, the greater the risk of temperature deviation or delays. Choose direct flights for international shipping where possible. Also be mindful of external temperatures – shipping through very hot or cold climates might require packaging with more buffer or special handling. Some logistics providers offer temperature-controlled truck service to and from airports to avoid exposing shipments on the tarmac. It’s often worth using priority freight services for medicines to shorten time out of storage.
3. Real-Time Monitoring in Transit: Just as warehouses are monitored, shipments can be tracked with data loggers. Many companies include GPS-enabled temperature monitors that provide live data on a cloud platform. If a threshold is breached or a shipment is delayed in a wrong location, the company can be alerted and take action (e.g., re-icing a package, expediting clearance). Such IoT-based monitoring has become more prevalent – as noted, 69% of pharma firms have automated real-time cold chain monitoring in place​ (sdcexec.com). These devices also create an electronic record that the product stayed within the acceptable range, which is important for quality assurance.
4. Trained Logistics Partners: Ensure that all parties in the chain – freight forwarders, airlines, couriers – are experienced with pharmaceuticals. They should understand urgency (no waiting around on the tarmac or in customs), have facilities like refrigerated storage if there’s a layover, and follow any special instructions (like do not x-ray, if applicable for certain biologics). Working with logistics providers who specialize in healthcare reduces risks. Some regions have logistics “cold hubs” at airports with freezer farms and cooler rooms; directing shipments through these hubs can be safer.
5. Detailed Procedures and Communication: Provide clear handling instructions with the shipment (both on the box and in documents). For example, labels indicating “Store at 2-8°C. Do not freeze. Open and place in cold storage upon arrival.” Also, include emergency contact numbers on the shipment so that if any issue arises, personnel know who to call 24/7. Internally, have a standard operating procedure for your team on what to do when a shipment arrives (e.g., check logger data immediately, inspect for damage, then move to storage). Standardization ensures no steps are missed.
6. Review and Continuous Improvement: After major shipments or periodically, review performance. Did any shipments come close to temp limits? Were there any delays? Gather data and work with your logistics partners to improve routes, packaging, or processes. Continuous improvement is a key principle of cGMP – learning from each shipment helps strengthen the system.

Compliance and Accountability

Regulators expect that companies know and control their distribution chain. During inspections or audits, firms may need to show evidence that their storage facilities are qualified and their shipping methods are validated. It’s wise to maintain a qualification dossier for each packaging configuration (showing test results for temperature maintenance) and for any third-party warehouses used (audits reports, etc.). Many organizations also perform lane qualifications – basically test shipments or thermal modeling for new shipping lanes to verify that packaging will hold up under specific transit conditions.

Another best practice is having a robust recall/return procedure. GDP guidelines require the ability to recall products promptly​ (ema.europa.eu). This means keeping distribution records such that you know exactly which batches went where, and having a logistics plan to retrieve any distributed stock if needed. It ties into traceability systems and is part of compliance. Even a startup should have a basic recall plan drafted as soon as they start distributing product, just in case.

Finally, don’t forget training: everyone involved, from warehouse staff to those packing a shipping container, should be trained in these best practices and the reasons behind them. When people understand that a short temperature spike could make a cancer drug less effective, they appreciate the importance of following procedures to the letter.

By adhering to cGMP/GDP best practices in storage and shipping, pharmaceutical companies ensure that patients receive medications that are as safe and effective as when they left the factory. This protects patients and also the company’s reputation and bottom line.

Call to Action

Maintaining a flawless cold chain and compliant storage is complex, but you don’t have to manage it alone. Euro-American Worldwide Logistics specializes in cGMP-compliant storage (2°C–8°C, 15°C–25°C, frozen, and ultra-cold) and end-to-end temperature-controlled shipping. We help implement all the best practices outlined above – from validated packaging to real-time monitoring. Contact Euro-American Worldwide Logistics today to safeguard your pharmaceutical products with our state-of-the-art cold chain solutions and expert handling. Let us worry about compliance and quality, so you can focus on your core mission of improving health.

Biologic medicines – from vaccines and insulin to advanced cell and gene therapies – are often temperature-sensitive and require strict cold chain management. In recent years, the rise of biologics has brought new challenges in storing and transporting these fragile products, especially those needing ultra-cold conditions. Looking ahead, cold chain management for biologic drugs is evolving with innovative technologies like ultra-cold storage solutions and AI-driven monitoring, alongside heightened regulatory expectations for quality. In this section, we discuss emerging innovations, regulatory standards, and best practices to ensure the integrity of biologic therapies throughout their journey to patients.

Rising Demands and Ultra-Cold Innovations

The growth of biologics is accelerating: nearly all new biotech drugs (monoclonal antibodies, gene therapies, mRNA vaccines, etc.) require some level of refrigeration​. Many biologics must be kept at 2°C to 8°C (36°F–46°F), and some, like certain vaccines or cell/gene therapies, need ultra-low temperatures of -70°C or below​ (pharmaceuticalcommerce.com,  grandviewresearch.com). Maintaining these temperatures from manufacturing through last-mile delivery is critical – any deviation can reduce a drug’s efficacy or even render it harmful​ (pmc.ncbi.nlm.nih.gov). For example, the mRNA COVID-19 vaccines highlighted the challenge: Pfizer’s vaccine initially required around -70°C storage, spurring a scramble for specialized freezers and dry ice shippers worldwide.

In response to these needs, companies are investing in ultra-cold chain innovations:

• Advanced Freezer Technology: New generations of ultra-low temperature (ULT) freezers offer more reliable cooling to -80°C or -100°C with better energy efficiency and temperature uniformity. Some designs use liquid nitrogen-based systems or novel compressor technologies to maintain ultra-cold temps more stably. Portable ULT freezers (small, battery-powered units) have also been introduced to facilitate field use, such as transporting gene therapy doses to clinics without temperature excursions.
• High-Performance Insulated Packaging: Packaging suppliers have developed shippers with superior insulation (using vacuum panels, phase-change materials, etc.) that can hold ultra-cold temperatures for longer durations. Dry ice remains a staple coolant for -70°C shipment; innovative shippers can extend dry ice sublimation time and minimize hotspots. For instance, there are pallet-size “deep freeze” containers that use rechargeable coolant or gel-based refrigerants to keep contents at ultra-cold conditions for several days, even if external temperatures fluctuate.
• Continuous Dry Ice Replenishment Systems: A novel approach for long shipments is using IoT-enabled containers that can automatically replenish dry ice from a built-in cartridge when sensors detect temperature rising. This can greatly reduce risk of losing cold temperature in transit, especially for intercontinental shipments subject to delays.
• Monitoring-Integrated Containers: Manufacturers like Envirotainer and others have introduced container systems (like the Envirotainer Releye series) that provide real-time temperature monitoring and control inside the unit​ (pharmaceuticalcommerce.com). These containers have sensors and can actively adjust internal conditions or alert a remote control tower if attention is needed (for example, if dry ice is running low or if a door was opened). Having “live monitoring” capability built-in means excursions can be corrected before products are compromised.

Importantly, beyond technology, some firms are exploring reducing cold chain dependency altogether. Researchers have called it the grand challenge of “ridding the cold chain” – through formulation science that makes biologics more stable at ambient temperatures​ (pmc.ncbi.nlm.nih.gov). While promising (e.g., freeze-dried or shelf-stable formulations of vaccines), such breakthroughs are on the horizon but not yet widely available. In the near term, the focus is on strengthening the cold chain via innovation rather than eliminating it.

AI-Driven Temperature Monitoring and Data Analytics

One of the most impactful trends in cold chain management is the integration of digital monitoring and AI analytics to oversee temperature control in real time. Traditional methods relied on data loggers that recorded temperatures for later download. In contrast, modern systems use IoT sensors that continuously transmit data to the cloud, enabling immediate response if something goes wrong.

AI-driven monitoring takes this a step further by not just collecting data, but also analyzing it to predict and prevent problems:

• Predictive Analytics: By analyzing temperature patterns and shipment routes, AI algorithms can predict the risk of a temperature excursion before it happens. For example, if a certain logistics lane historically has delays or a certain time of day tends to warm shipments, AI can flag high-risk shipments and suggest adding extra coolant or adjusting the route. Predictive models can factor in weather forecasts, traffic, flight delays, etc., to anticipate challenges to a shipment maintaining its required temperature.
• Anomaly Detection: Machine learning algorithms quickly learn what “normal” temperature curves look like for a product in a given container. If a sensor begins to report data that deviates from the norm (even slightly), the system can raise an alert to a human operator. This might catch, say, a cooling unit starting to fail, or a container left on a tarmac too long, before the product goes out of spec. Early detection means saving a shipment that might otherwise spoil.
• Cold Chain Control Towers: Many pharma companies or 3PL providers now operate centralized monitoring hubs (control towers) staffed 24/7. These centers use dashboards aggregating live data from shipments around the world. AI tools in the control tower software triage the data, so staff can focus on shipments that need intervention. For instance, an AI might highlight that “Shipment XYZ’s internal temperature is trending up faster than expected” – enabling staff to contact the carrier at the next stop to check the container’s coolant or move it to a colder storage area. Envirotainer and other container providers link their live monitoring to such control tower services for proactive management​ (pharmaceuticalcommerce.com).
• Asset Management and Maintenance: AI is also applied to cold storage equipment maintenance. By monitoring freezer performance data, algorithms can predict when a freezer is likely to fail or when it needs servicing. This predictive maintenance avoids catastrophic freezer failures that could ruin entire inventories of biologics.

Real-world collaborations underscore this trend. For example, logistics provider World Courier partnered with Controlant (an IoT monitoring company) to integrate real-time condition monitoring into shipments, and Cryoport, a leading cryogenic logistics firm, has incorporated AI/ML techniques to better serve cell/gene therapy clients​ (pharmaceuticalcommerce.com). Cryoport’s CEO noted that combining condition monitoring, cloud platforms, and AI has improved supply chain visibility for these ultra-cold shipments​ (pharmaceuticalcommerce.com).

AI-driven cold chain management delivers value by reducing product loss (through early intervention) and by documenting compliance (proving to regulators that required conditions were maintained). It also optimizes operations – AI might find that certain lanes consistently use less dry ice than estimated, allowing cost savings by packing less, or conversely flag lanes where more cooling should be added as a precaution.

Regulatory Expectations for Biologics Logistics

Regulators worldwide are acutely aware of the risks associated with biologic product handling. Agencies like the FDA in the U.S. and EMA in Europe have stringent requirements to ensure that product quality is maintained throughout distribution. Several key expectations and regulations include:

• Good Distribution Practice (GDP) Guidelines: These are guidelines (e.g., EU GDP, WHO GDP) that outline how medicinal products should be transported and stored. They require that companies have qualified equipment, validated processes for packing and shipping, and systems in place to monitor conditions. Deviations (excursions outside labeled temperature) must be documented and investigated. Companies are expected to perform route risk assessments and temperature mapping for their shipping lanes as part of validation.
• 21 CFR Part 211 (FDA cGMP for finished pharmaceuticals): Within FDA regulations, 21 CFR 211.150 and related sections mandate that manufacturers have distribution procedures to ensure drug quality, including using appropriate storage conditions and maintaining records​. While this mostly covers having procedures for recalls and stock rotation (FEFO – First Expiry, First Out), implicitly it requires that products are shipped under conditions that will not compromise them. Failure to do so can be cited in FDA inspections (Form 483 observations).
• 21 CFR 203 (PDMA storage): For prescription drug samples, 21 CFR 203.32 specifically requires samples be stored and handled under labeled conditions​ (elangham.com). Although this is about samples, it reflects FDA’s stance that any deviation from required temperature is a violation. Similarly, USP guidelines (United States Pharmacopeia) such as <1079> on Good Storage and Distribution Practices provide industry-accepted standards for maintaining proper environments.
• Regulator Inspections and Enforcement: Companies should expect that regulators will audit their cold chain controls. FDA inspectors can inspect warehouses, 3PL facilities, and even review transit data. If a company cannot demonstrate that its biologics stayed within the labeled temperature range, the product might be deemed adulterated. Import shipments can be held if they arrive with evidence of temperature abuse. In worst cases, regulatory actions like product seizures or recalls occur when cold chain breaches are discovered and not managed.
• Stability Data and Excursion Allowances: As part of drug approval, manufacturers establish stability profiles for their biologics (e.g., how long it can be at room temp vs. refrigerated). Regulators expect companies to have this data and define allowable excursions (for instance, a product might be labeled “store 2-8°C, excursions up to 25°C permitted for 24 hours”). Logistics teams must adhere to these limits. If an excursion beyond what the stability data supports happens, the product generally should not be used without a scientific assessment. This means every link in the chain must be trained to immediately report excursions so that quality teams can evaluate impact.

In summary, regulatory expectations can be boiled down to continuous control and documentation. Every biologic drug developer should have a robust cold chain management program as part of their quality system. This includes qualifying shipping containers, monitoring each shipment, and having SOPs for what to do if something goes wrong (e.g., using backup inventory, notifying health authorities if a batch is compromised). Regulators in 2025 are unlikely to be lenient about lapses – the technology and processes to assure cold chain are available, and firms are expected to use them. The FDA has even worked on advanced initiatives (in partnership with NIST and others) to improve temperature monitoring methods for biologics​ (fda.gov), indicating how critical this area is.

Best Practices to Ensure Biologic Drug Integrity

Given the high stakes, companies handling biologic drugs should follow best practices that marry technological solutions with operational excellence:

• Validate and Qualify Everything: Use only qualified shippers and storage units for your products. Conduct test shipments (summer and winter profiles) to ensure packaging holds required temperatures for worst-case durations. Re-qualify if routes or seasonality changes. Validate lanes with dummy shipments if introducing a new distribution route.
• Employ Redundant Safeguards: Build in redundancy where possible. For example, use dual temperature monitors per shipment (in case one fails). Have backup power generators for storage freezers. If a product is extremely valuable (like a patient-specific cell therapy), consider sending it with two couriers via different routes to hedge against one failing to arrive on time.
• Use Real-Time Monitoring and Alerts: As discussed, implement IoT monitoring on all critical shipments. Set up alert protocols so that if a temperature excursion is impending, key personnel are notified immediately via email/SMS. Some companies contract third-party monitoring services that will intervene 24/7 if an alert triggers – for instance, instructing a driver to refill dry ice mid-transit. Rapid response can save a product from a complete loss.
• Enhance Visibility with Data Platforms: Utilize centralized platforms to track all shipments in transit. Having a single dashboard for all logistics partners and carriers makes oversight easier. This should include not just temperature, but also location tracking. Knowing exactly where a shipment is and its condition in real time allows for faster decision-making.
• Staff Training and SOPs: Ensure all staff (and logistics partners’ staff) are trained in handling cold chain products. Simple human errors, like leaving a box out on a loading dock, can break the cold chain. Emphasize standard operating procedures such as pre-cooling trucks before loading, minimizing exposure during transfers, and checking container seals. Train teams on what to do if an excursion occurs – e.g., quarantine products, retrieve data, etc. Clear roles and communication channels are vital during excursions.
• Contingency Planning: Incorporate contingency plans in your supply chain strategy. If a primary route is disrupted (say a flight cancellation or a customs delay), have alternative routing ready. Maintain a network of backup warehouses or freezers in strategic locations. For ultra-cold material, know the nearest facilities en route that could store the product if an emergency arises (some airports or cities have specialty pharma storage where a shipment could be held safely if needed).
• Regular Audits and Continuous Improvement: Treat cold chain like a living process. Regularly audit performance – how many excursions happened per 100 shipments? Investigate root causes and implement fixes (whether it’s better packaging, different logistic partners, or additional training). Also, keep an eye on new technologies or services. For example, drone delivery is emerging for rapid transport of medical products – if applicable, this might cut transit times and reduce risk for remote areas​ (grandviewresearch.com). Continuously improving the process will both satisfy regulators and reduce costs of waste.

By adhering to these best practices, companies can achieve near-zero loss of product due to cold chain failures. More importantly, patients will receive medications that are effective and safe, as intended.

Conclusion and Call to Action

The future of biologic drug cold chain management is being shaped by innovation and higher standards. With more high-value, temperature-sensitive therapies in the pipeline, the industry must deploy ultra-cold solutions, real-time AI monitoring, and rigorous quality systems to protect product integrity. Those that do will not only comply with regulators but also gain efficiency and trust in the market.

Euro-American Worldwide Logistics specializes in life science logistics and cold chain solutions. We offer state-of-the-art ultra-cold storage options, IoT monitoring technology, and logistics expertise to ensure your biologics remain within temperature from factory to patient. Don’t leave your critical therapies to chance – contact Euro-American Worldwide Logistics for a tailored cold chain strategy that leverages the latest innovations and best practices to safeguard your biologic products.

References

Basta, N. (2024, April 3). The Pharma Cold Chain: More Visible, More Sustainable — and Colder. Pharmaceutical Commerce​
pharmaceuticalcommerce.com
​
Taraban, M. B. et al. (2021). Grand Challenges: Ridding the Cold Chain for Biologics. AAPS PharmSciTech, 22(3)​
pmc.ncbi.nlm.nih.gov
​
Grand View Research. (2023). Healthcare Cold Chain 3PL Market Report, 2020-2030​
grandviewresearch.com
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Miller & Chevalier. (2025, Jan 14). UFLPA Enforcement 2024 Year in Review (CBP statistics on detentions)​
millerchevalier.com

Langham Logistics. (2020, Dec 23). Understanding Cold Chain Logistics and FDA Compliance​
elangham.com

Berlinger & Co. (2024). Cutting-Edge Monitoring Tech Transforming Cold Chain (Collaboration examples with World Courier, Controlant)​
pharmaceuticalcommerce.com

Introduction

As the pharmaceutical landscape faces slowing growth in traditional strongholds, major pharmaceutical companies are turning their focus towards emerging markets. Countries like India, China, and Brazil are witnessing significant investments from Big Pharma, driven by the need to tap into these rapidly growing economies. According to IQVIA data, between 2016 and 2021, the pharmaceutical markets in Brazil, China, and India grew by 11.7%, 6.7%, and 11.8%, respectively, compared to an average growth of 5.8% in the top five EU markets and 5.6% in the U.S. market.

Strategic Shifts in Emerging Markets

The shift towards emerging markets is not just about capitalizing on growth but also about fostering innovation and improving accessibility to critical medications. Vasant Narasimhan, CEO of Novartis, recently announced that the company aims to make India a hub for innovation, focusing on artificial intelligence, data science, and basic science research. India, which already houses 8,300 Novartis associates, is poised to play a pivotal role in the company’s global strategy.

Similarly, companies like Merck KGaA and Bristol Myers Squibb (BMS) have tailored their strategies to meet the unique needs of emerging markets. Merck KGaA’s “Triple A” framework focuses on availability, accessibility, and affordability of its healthcare portfolio in low and middle-income countries (LMICs). The company aims to treat over 80 million patients per year in LMICs by 2030, up from 55 million in 2022.

BMS has introduced the ASPIRE strategy, which stands for Accessibility, Sustainability, Patient-centric, Impact, Responsibility, and Equity. This strategy includes creating new access pathways for BMS medicines by launching Emerging Market Brands (EMBs), which use tiered pricing to reflect each country’s ability to pay. BMS aims to reach more than 200,000 patients in LMICs by 2033.

Challenges and Opportunities

Despite the immense opportunities, pharmaceutical companies face several challenges in emerging markets. These include regulatory complexities, intellectual property (IP) issues, political instability, and the need for equitable access to therapies across diverse socioeconomic segments. Companies must navigate these hurdles while ensuring that their investments lead to meaningful health outcomes.
Collaboration with local stakeholders is crucial for overcoming these challenges. For example, Merck & Co. entered a licensing agreement with Indonesia’s Biofarma to produce its HPV vaccine locally, supporting the country’s national immunization program. Such partnerships enable companies to better understand local market dynamics and establish strong distribution channels.

The Role of Euro-American Worldwide Logistics

As pharmaceutical companies expand into emerging markets, the logistics of materials management become increasingly complex. This is where Euro-American Worldwide Logistics can make a significant impact. With our expertise in global logistics, we can help pharmaceutical companies navigate the unique challenges of emerging markets by providing tailored solutions that ensure the efficient and reliable distribution of products. From managing supply chains to ensuring timely deliveries, Euro-American Worldwide Logistics is committed to supporting the pharmaceutical industry’s expansion into these critical markets.

Conclusion

The strategic shift of Big Pharma towards emerging markets represents a significant opportunity for growth and innovation. However, to capitalize on this potential, companies must navigate a complex landscape of challenges. By leveraging local partnerships, adopting tailored strategies, and utilizing the logistics expertise of companies like Euro-American Worldwide Logistics, pharmaceutical firms can ensure that their products reach the patients who need them most.

Reference: Article by Soman Harachand, Contributing Writer, Contract Pharma 07.22.24

Introduction

The Contract Development and Manufacturing Organization (CDMO) sector has become a critical player in the U.S. pharmaceutical industry, particularly as companies increasingly outsource drug development and manufacturing to focus on core competencies. With the rise of advanced therapeutics, such as cell and gene therapies, and the ongoing pressures of a post-pandemic market, CDMOs face new challenges in ensuring efficiency, scalability, and resilience in their operations. A key strategy for addressing these challenges lies in the integration of third-party satellite facilities to support materials management and supply chain continuity.

The Role of CDMOs in Pharmaceutical Manufacturing

CDMOs provide specialized services that encompass the entire pharmaceutical lifecycle, from early-stage drug development to commercial-scale manufacturing. This model allows pharmaceutical companies to leverage the technical expertise and advanced capabilities of CDMOs while reducing the need for substantial investments in infrastructure. The U.S. CDMO market has seen significant growth, driven by the increasing complexity of drug formulations and the demand for innovative treatments. However, this growth also introduces challenges, particularly in managing the complex supply chains that are critical to pharmaceutical manufacturing.

The Strategic Importance of Third-Party Satellite Facilities

Enhancing Materials Management

Materials management is a crucial aspect of pharmaceutical manufacturing, requiring the precise coordination of raw material procurement, storage, and distribution. Third-party satellite facilities can optimize this process by providing localized storage and distribution hubs, reducing transportation costs and lead times. These facilities ensure that materials are available when needed, preventing production delays and maintaining the integrity of the supply chain.

Mitigating Supply Chain Risks

Supply chain disruptions can have significant consequences for CDMOs, including production delays, increased costs, and regulatory challenges. Third-party satellite facilities provide additional capacity and redundancy, mitigating these risks by ensuring a continuous supply of materials even in the face of disruptions. The strategic placement of these facilities near key markets also enhances supply chain resilience, allowing CDMOs to respond quickly to changes in demand.

Supporting Sustainable Practices

Sustainability is increasingly important in pharmaceutical manufacturing, with a growing emphasis on reducing environmental impact. Third-party satellite facilities can contribute to sustainability goals by minimizing transportation distances, incorporating energy-efficient technologies, and implementing waste reduction strategies. This localized approach not only supports environmental objectives but also improves overall operational efficiency.

Conclusion

As the U.S. CDMO sector continues to evolve, the integration of third-party satellite facilities into materials management strategies is becoming essential. These facilities enhance supply chain resilience, optimize materials management, and support sustainability efforts, all of which are critical to the success of CDMOs in a competitive market.

Euro-American Worldwide Logistics offers tailored solutions that align with these needs, providing strategically located satellite facilities that enhance the efficiency, resilience, and sustainability of CDMO operations. By partnering with Euro-American, CDMOs can navigate the complexities of modern pharmaceutical manufacturing with greater confidence and agility.