Cell and gene therapy (CGT) and global supply chain security

In the biopharmaceutical industry, cell and gene therapy (CGT) emerges as a compelling and rapidly advancing field of medicine. Recent developments include autologous and allogeneic cell therapies and personalized treatments using patient or donor cells.

One challenge the CGT industry is facing is the establishment of secure and reliable supply chains for critical Good Manufacturing Practice (GMP)-grade raw and ancillary materials for CGT manufacturing.

This article discusses key aspects of maintaining material supply chains, including supply chain management, warehouse inventory management, transportation logistics, and adherence to international trade compliance.

Supply chain management

When considering GMP-grade raw materials for CGT production, it is vital to inquire whether a supplier can consistently meet the raw materials requirements throughout clinical trials and into commercialization. Careful choice of supplier is vital, as the success of a CGT relies heavily on the quality and consistency of ancillary materials.

When evaluating prospective suppliers, their supplier chain management for GMP-grade raw materials must be considered, including robust supply agreements, stringent supplier management practices, and transparent supplier communication.

Robust supply agreements are necessary to ensure the availability of high-quality GMP-grade ancillary materials. They must outline quality standards, delivery schedules, and contingency plans to avoid possible supply chain disruptions.

Potential measures include securing large batches reserved for one customer and validating a second supplier, both of which help to secure the supply chain and final product stability, particularly when scaling up from clinical trials to large-scale commercial manufacturing.

Stringent supplier management practices are vital in ensuring the quality and consistency of GMP-grade ancillary materials. Measures include comprehensive qualification collection, on-site audits, and the establishment of a GMP-grade quality management system to ensure compliance with international standards and regulatory guidelines.

Another crucial aspect of supply chain management for GMP-grade ancillary materials is transparent communication with suppliers. The appointment of a communications lead, and the establishment of a well-defined issue escalation pathway for key suppliers, ensures alignment on key priorities and potential challenges. Regular business review meetings with key suppliers further enhance collaboration and transparency.

Warehousing and inventory management

Warehousing and inventory management are crucial for ensuring the safe storage, precise distribution, and efficient turnover of materials and products, mitigating the risk of supply chain disruptions.

GMP-grade materials are hypersensitive; thus, warehouses must adhere to strict audits, encompassing controls over factors such as temperature, cleanliness, humidity, turnover rates, expiration, and timely shipment processes. Precise inventory management with full lifecycle traceability is central to ensuring the safety and quality of raw materials.

ACROBiosystems' comprehensive management system

ACROBiosystems has established an Order and Material Product Management System (OA-CRM-ERP-WMS-WCS) to streamline operations. It includes several features, including business opportunity management, GMP product classification, automated order conversion audits, unique identification for material products, and end-to-end product lifecycle tracking.

Using barcodes, QR codes, and RFID labels, ACROBiosystems ensures complete lifecycle traceability and management, guaranteeing a consistent and stable supply of high-quality GMP raw materials.

Cell and gene therapy (CGT) and global supply chain security

Image Credit: ACROBiosystems 

Global warehousing presence

To maintain global delivery of products, the establishment of warehouses and logistic centers is critical. ACROBiosystems has three centers, in the United States, EU, and China, guaranteeing fast product delivery to customers.

  • North American International Logistics Center: Located on the East Coast and operational for over 10 years, this center is ISO9001 and ISO13485 certified, with a finished product warehouse capacity exceeding 500,000 units.
  • European Logistics Center: This center serves over 90 % of European customers and aims for ISO9001 and ISO13485 certification by 2024, enhancing the speed of services.
  • Beijing Logistics Center: This center, operational for over 13 years, oversees global warehousing logistics, implementing automated, low-temperature storage management with a capacity of up to 1.5 million units. It is also ISO9001 and ISO13485 certified.

Robust inventory management

Regular inventory checks and quality inspections, in line with internal control and audit standards, are integral to the ACROBiosystems approach. Incorporating safety stock alerts and an AI-driven Material Requirements Planning (MRP) mechanism for timely procurement, the ACROBiosystems inventory management system ensures supply remains consistent in the event of unforeseen circumstances and market fluctuations.

Optimizing warehousing efficiency

Based on its customers’ needs and future plans, ACROBiosystems continually optimizes warehousing layout design automation, digitalization, and intelligent transformation to improve efficiency and space utilization.

In compliance with GMP requirements, storage areas are strategically divided and material classification is employed to prevent cross-contamination, ensuring a high-quality, secure storage environment.

Transportation logistics

International transportation logistics are crucial in linking all aspects of the raw material supply chain. During transportation, environmental factors including humidity, temperature, and vibrations can cause irreversible damage to sensitive GMP-grade raw materials, escalating logistics costs and complexity.

The establishment of a reliable transportation logistics system is therefore of paramount importance, ensuring timely and secure delivery of GMP-grade raw materials and enhancing the reliability and efficiency of the CGT manufacturing supply chain.

ACROBiosystems has partnered with globally renowned and highly reliable logistics suppliers with extensive experience in the biopharmaceutical industry and a specialized understanding of the nature of GMP-grade raw materials.

These partnerships provide secure and reliable transportation services across various temperature ranges, guaranteeing compliance with industry regulations and traceability, and aligning with transportation specifications for critical GMP materials.

For customers in the Americas and Europe, more than 90 % of deliveries are completed within three days. Globally, 97 % of shipments are in transit within three working days.

Temperature monitoring and tracking are employed continuously throughout the transportation process. This system rapidly identifies anomalies, ensuring immediate actions are taken to keep temperatures within an acceptable range, guaranteeing the integrity and safety of raw materials during transportation.

ACROBiosystems has a thoroughly developed plan, involving transportation and route planning, to ensure the timely delivery of GMP-grade raw materials. It employs tailored packaging materials and containers based on the unique characteristics of different materials and destination requirements, selecting the optimal mode of transportation (including land and air). Transportation times are carefully arranged to reduce the risk and time associated with transporting raw materials.

International trade compliance

For the global therapeutic technology landscape of CGT, managing the global transport of raw materials is central to supply chain management. However, due to diverse regulatory environments and trade policies across the globe, navigating international trade remains a challenge.

Regulations and tax policies for CGT products vary and have the potential to restrict certain imports and exports, introducing extra compliance costs and delays for biopharma.

It is essential to adopt a strategic approach for the evaluation and management of international import and export operations to minimize risks, enhance efficiency, and ensure a stable supply of key GMP-grade raw materials. A fundamental understanding of the import-export regulations and tax policies in the target market is essential for successful international trade.

Table 1. List of Relevant International Regulations. Source: ACROBiosystems 

Cell and gene therapy (CGT) and global supply chain security

ACROBiosystems is unwavering in its commitment to understand and adhere to pertinent international trade laws, regulations, and standards, with an emphasis on ensuring the compliance of import and export operations.

This involves familiarization with the import-export requirements and procedures of targeted markets and the establishment of robust document management and filing systems to minimize potential legal risks.

ACROBiosystems has developed stable partnerships in its supply chain network, incorporating suppliers, agents, and service providers, guaranteeing supply chain stability and reliability.

Existing service providers are regularly assessed to ensure their ability to consistently deliver high-quality services and new service providers are carefully evaluated based on reputation, qualifications, and professional competence, particularly in handling emergencies.

Particular attention is paid to information sharing and the adoption of local business practices. ACROBiosystems supports specialized, localized services via close ties with relevant departments, partners, and local governments. This proactivity ensures a rapid response to changes and trends in international trade policies, allowing for prompt adjustments and informed decision-making.

ACROBiosystems aims to navigate the complexities of international trade and ensure strict compliance with internal laws and regulations, guaranteeing a seamless and lawful global operation.

Summary

ACROBiosystems has cultivated an effective global supply chain system that encompasses careful management of GMP-grade products, allowing the company to match the ever-increasing demand for high-quality materials in CGT manufacturing.

ACROBiosystems employs stringent supplier agreements, transparent communication, and advanced warehousing via its comprehensive management system, which includes features like end-to-end product tracking and efficient inventory management, to meet the growing needs of CGT manufacturing.

This strategic approach extends to global warehousing, transportation partnerships, and a commitment to international trade compliance, cementing ACROBiosystems as a key contributor to the expanding field of CGT.

About ACROBiosystems

ACROBiosystems is a cornerstone enterprise of the pharmaceutical and biotechnology industries. Their mission is to help overcome challenges with innovative tools and solutions from discovery to the clinic. They supply life science tools designed to be used in discovery research and scalable to the clinical phase and beyond. By consistently adapting to new regulatory challenges and guidelines, ACROBiosystems delivers solutions, whether it comes through recombinant proteins, antibodies, assay kits, GMP-grade reagents, or custom services. ACROBiosystems empower scientists and engineers dedicated towards innovation to simplify and accelerate the development of new, better, and more affordable medicine.


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Last updated: Feb 12, 2024 at 11:11 AM

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