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> Global Supply Chain Security System for GMP Products 
In the ever-evolving landscape of biopharmaceutical industry, cell and gene therapy (CGT) emerges as a highly compelling and rapidly advancing field. At the forefront of these breakthroughs includes autologous and allogeneic cell therapies, personalized treatments involving a patient's own cells or donor cells for a select population. Nevertheless, a challenge facing the CGT industry lies in ensuring a secure and reliable supply chain for critical Good Manufacturing Practice (GMP)-grade raw and ancillary materials for CGT manufacturing. This article explores critical aspects of maintaining a material supply chains, including supply chain management, warehouse inventory management, international transportation logistics, and trade compliance, to support the growing demands of CGT manufacturing.
In the intricate landscape of GMP-grade ancillary materials for CGT manufacturing, the pivotal role of warehousing and inventory management cannot be overstated. These functions are crucial for ensuring the safe storage, precise distribution, and efficient turnover of materials and products, ultimately mitigating the risk of supply chain disruptions.
Given the hypersensitive and vulnerable nature of GMP-grade materials, warehouses must adhere to stringent standards, including controls for temperatures, humidity, cleanliness, expiration, turnover rates, and timely shipment processes. The emphasis on precise inventory management with full lifecycle traceability becomes the foundation to guarantee the safety and quality of raw materials.
To streamline operations, we established an Order and Material Product Management System (OA-CRM-ERP-WMS-WCS). This system includes features such as business opportunity management, automated order conversion audits, unique identification for material products, GMP product classification, and end-to-end product lifecycle tracking. By leveraging barcodes, QR codes, and RFID labels, we ensure complete lifecycle traceability and management to guarantee our customers a consistent and stable supply of high-quality GMP raw materials.
North American International
Logistics Center
Operational for over 10 years on the East Coast, this center is ISO9001 and ISO13485 certified, with a finished product warehouse capacity exceeding 500,000 units.
European Logistics Center
Serving over 90% of European customers, this center aims for ISO9001 and ISO13485 certifications by 2024, enhancing the speed of services.
Beijing Logistics Center
Operational for over 13 years and holds ISO9001 and ISO13485 certifications. This center in China oversees global warehousing logistics, implementing automated low-temperature storage management with a capacity of up to 1.5 million units.
International transportation logistics serve as the crucial link connecting various facets within the raw material supply chain. Given the sensitivity of GMP-grade raw materials, environmental factors such as temperature, humidity, and vibrations during transportation can exert irreversible impacts on their quality, thereby escalating logistics costs and complexity. Therefore, establishing a reliable transportation logistics system is of utmost importance. A stable logistics system ensures the timely and secure delivery of GMP-grade raw materials, enhancing the efficiency and reliability of the CGT manufacturing supply chain.
In light of this, we have strategically partnered with globally renowned and highly reliable logistics suppliers. These logistics partners bring extensive experience in the biopharmaceutical industry and possess a specialized understanding nature of GMP-grade raw material. They offer secure and reliable transportation services across different temperature ranges, ensuring compliance with industry regulations and traceability, aligning with the transportation specifications for critical GMP materials. To our Americas and Europe customers, more than 90% of deliveries are accomplished within three days. Globally, 97% of shipments are in transit within three working days.
Furthermore, a temperature monitoring system is implemented throughout the transportation process, enabling continuous monitoring and tracking. This system detects anomalies promptly, allowing for immediate actions to ensure temperature control remains within acceptable ranges, safeguarding the safety and integrity of the raw materials during transportation。
In addition, we have a thoroughly developed plan encompassing transportation and route planning, ensuring the timely delivery of GMP grade raw materials for customers. Tailoring packaging materials and containers based on the unique characteristics of different materials and destination requirements, the company selects the optimal transportation mode, including air and land transportation. Transportation times are thoughtfully arranged to minimize both the time and risk associated with raw material transportation.
Managing the international movement of critical raw materials is a crucial aspect of supply chain management in the global therapeutic technology landscape of CGT. Yet, navigating international trade remains challenging due to diverse regulatory landscapes and trade policies across countries and regions. Distinct regulations and tax policies for CGT products vary, potentially restricting certain imports or exports. This introduces extra compliance costs and time delays for biopharma. A strategic approach to evaluating and managing international import and export operations is essential 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 the key to successful international trade.
We are unwavering in our commitment to continuous learning, understanding, and adherence to pertinent international trade laws, regulations, and standards. Our emphasis is on ensuring the compliance of its import and export operations. This involves familiarizing itself with the import-export specifications and procedures of the targeted market, establishing robust document management, and filing systems to minimize potential legal risks.
Internally, we have nurtured stable partnerships within its supply chain network, encompassing suppliers, agents, and service providers. These enduring and positive collaborations guarantee the stability and reliability of the supply chain. Regular assessments of existing service providers are conducted to ensure their capability to consistently deliver high-quality services. In addition, when required, new service providers are carefully evaluated based on their qualifications, reputation, and professional competence, particularly in handling unforeseen emergencies.
We also place significant emphasis on information sharing and adopting localized business practices. By maintaining close ties with relevant departments, partners, and local governments, ACROBiosystems advocates for specialized, localized services. This proactive approach enables them to stay abreast of changes and trends in international trade policies promptly, facilitating timely adjustments and informed decision-making in their business operations. The overarching goal is not only to navigate the complexities of international trade but to do so in strict compliance with internal laws and regulations, ensuring a seamless and lawful global operation.
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