Supply Chain Challenges
In "The Guard Rail" this week, we're diving into a challenge that defines the pharmaceutical and biotech industries: the delicate balance between Time, Quality, and Cost.
For Metis Consulting Services
By Michael Bronfman
This week’s Guard Rail discusses one exciting therapeutic area that is changing the world of medicine. at a breakneck pace. We will delve into the unique challenges that distinguish the cell and gene therapy supply chain. From managing delicate cryogenic materials to ensuring that each patient's unique biological material is handled with absolute precision. Mastering this precision is not just a matter of good business; it is a matter of life and death for patients worldwide.
Supply Chain Challenges: Complexities in the Cell and Gene Space
The field of cell and gene therapy has experienced remarkable growth over the last decade. These therapies offer hope to patients with rare diseases, cancers, and other life-threatening conditions that have resisted traditional treatment. Driven by new clinical breakthroughs, the Pharmaceutical industry is racing to develop cell and gene products that can transform healthcare.
These therapies require more complex logistics, specialized facilities, and precise coordination among multiple players than traditional pharmaceuticals. The supply chain is not a linear process of producing pills in a factory and shipping them to pharmacies. It is instead a highly dynamic network that involves human cells, time-sensitive deliveries, and rigorous quality checks. The following discussion examines some of the complexities of the supply chain in the cell and gene therapy space, as well as the critical importance of these issues for the industry.
The Personalized Nature of Therapies
A central difference between cell and gene therapies and conventional drugs lies in the manner in which they are manufactured. Many cell therapies are designed for individual patients. For example, in autologous therapies, cells are collected directly from the patient, modified in a specialized facility, and then returned for infusion back into the same patient. This is a very different model compared to the mass production of tablets or vials.
Supply chains must handle thousands of individualized processes simultaneously, because each product batch is unique. Tracking, labeling, and verifying each sample are vital to avoid mix-ups that could have life-threatening consequences. This personalized model introduces an enormous amount of variability, which makes planning and scaling operations far more challenging than in traditional pharmaceutical manufacturing.
Chain of Identity and Chain of Custody
Two terms often repeated in the industry are chain of identity and chain of custody. The chain of identity ensures that a sample collected from a specific patient remains linked to that same patient throughout the entire process. The chain of custody is the detailed documentation of who handled the product at every stage. This includes where it was transported and under what conditions.
Maintaining that documentation requires advanced tracking technologies, digital platforms, and trained personnel at every handoff. A single error could result in the incorrect therapy being administered to the wrong patient. So the supply chain is one of the most sensitive areas in cell and gene therapy. Digital solutions can provide real-time monitoring and secure tracking across multiple sites, so many companies are investing heavily in this area.
Cold Chain Logistics
Temperature control is one of the most critical components of this supply chain. Many cell and gene therapies are extremely sensitive to temperature changes. Some must be kept at cryogenic temperatures as low as minus 150 degrees Celsius, while others must remain between 2 and 8 degrees Celsius.1Infrastructure Archives - VillageReach
Maintaining these conditions from the point of collection to the point of delivery is a monumental task. Specialized freezers, liquid nitrogen shippers, temperature monitoring sensors, and validated transportation partners are required. Even a short lapse in temperature control can compromise the integrity of the therapy.
Additionally, many therapies cannot be stored for extended periods of time. Their shelf life is often measured in days rather than months. Delays in customs, traffic, or weather can put entire treatments at risk; needless to say, this results in an immense amount of pressure on logistics teams to deliver products quickly and without incident.
Manufacturing Bottlenecks
The manufacturing process adds another layer of complexity. Unlike conventional drugs that are synthesized in bulk, cell and gene therapies require a more intricate set of customized bioprocessing steps.
Currently, the number of facilities capable of performing this type of manufacturing is limited. Capacity constraints create bottlenecks that can delay treatment for patients who may not have time to wait. We need to increase that number, but expanding manufacturing capacity requires significant investment. Increased investments in equipment, in trained personnel, and regulatory compliance. Furthermore, as science evolves rapidly, facilities must remain flexible to adapt to new processes and technologies.
Regulatory Complexity
Regulatory requirements for cell and gene therapies are among the most stringent in health care. Regulators demand extensive data on product safety, identity, purity, and potency. Additionally, every step of the supply chain must be validated and thoroughly documented. This level of oversight increases the already complex nature of operations. Companies must establish quality systems that meet the standards for review, auditing, and high regulatory requirements. They must also ensure that suppliers, logistics providers, and manufacturing partners comply with the same high standards. Achieving and maintaining compliance can slow down operations and add significant costs, but it is necessary to protect patients and maintain trust in the industry. 2Key Skills and Experience to Look for in Pharmaceutical Sales Talent.
Global Supply Chain Challenges
Cell and gene therapies are not limited to one country; clinical trials and treatments often span multiple continents. This creates multiple additional challenges related to transportation regulations, customs, and international quality standards.
For example, shipping cryogenic material across borders requires permits, specialized containers, and coordination with customs officials who may not always be familiar with the time-sensitive nature of such shipments. Variations in regulations between countries add another layer of complexity. A therapy that is approved in one country may face delays or restrictions in another.
These global challenges require close collaboration between regulators, manufacturers, and logistics providers. Standardization of procedures and alignment of regulations could help reduce delays and improve patient access.
Workforce and Training Issues
From laboratory technicians to logistics managers, cell and gene therapies require a highly trained workforce. The specialized nature of these therapies means every person involved must understand the sensitivity of the products and the importance of compliance. Unfortunately, there is a shortage of skilled professionals in this field.3CGT Applications Data Management - BioProcess International.
Recruiting, training, and retaining talent are challenges for most companies. The learning curve is steep, and mistakes can be costly. Additionally, as the industry continues to grow rapidly, competition for skilled workers is intensifying. Building a strong workforce is essential for strengthening the supply chain and ensuring the safe delivery of therapies.
Financial Pressures
The cost of developing and delivering cell and gene therapies is exceptionally high. Manufacturing processes are labor-intensive, facilities are expensive, and logistics require specialized equipment. All of these factors contribute to the high price of these therapies, which can exceed hundreds of thousands or even millions of dollars per patient.4 Zadig, S. M., & Tejay, G. (2012). Emerging Cybercrime Trends. Advances in Information Security, Privacy, and Ethics Book Series.
Every step in the supply chain must be carefully optimized to control costs without compromising safety. Waste reduction, efficiency improvements, and digital automation are key strategies. However, the bespoke nature of Cell and Gene therapies makes it difficult to achieve the economies of scale typically found in traditional pharmaceutical manufacturing.
The Role of Technology and Innovation
Despite these challenges, the forecast in our industry remains optimistic. New technology is significantly improving supply chains. Currently in use or soon to be introduced are digital tracking platforms, blockchain solutions, advanced sensors, and artificial intelligence-driven analytics. New methods to reduce errors and improve efficiency are being explored. Standardized modular facilities are being developed that can be rapidly deployed in different regions.
Automation in manufacturing is also helping to reduce variability and increase throughput. The promise in all of these innovations is creating more resilient supply chains and easing the current bottlenecks.
The Human Element
People place enormous trust in these therapies, often seeing them as their last hope. This reality adds urgency and responsibility to every decision made in the industry.
Healthcare providers, logistics partners, and manufacturers must work together with both compassion and precision. The supply chain in cell and gene therapy is not simply about moving products from one place to another. It is about ensuring that each patient receives the correct treatment at the right time, with no compromises in safety or quality.
The supply chain challenges in the cell and gene therapy space are unlike any seen in the history of medicine. Personalized products, strict regulatory requirements, temperature-sensitive logistics, manufacturing bottlenecks, and global coordination issues create a level of complexity that is unprecedented. At the same time, these therapies hold extraordinary promise. They have the potential to cure diseases that are considered untreatable. This could transform the future of health care.
To realize this potential, the industry must continue to invest in infrastructure, digital solutions, workforce development, and international collaboration. Overcoming supply chain challenges will not only save lives but also improve efficiency and the bottom line. The road ahead is difficult, but with continued innovation and commitment, the cell and gene therapy field can achieve its promise and deliver lasting hope to patients worldwide.
At Metis Consulting Services, we have seen firsthand that the logistics of Cell and Gene therapies are far more intricate than traditional pharmaceuticals. Contact us today to learn how we can help you optimize your operations and accelerate your path to delivering these life-changing therapies to patients. Hello@Metisconsultingservices.com