Mục ý kiến chuyên gia Biopharmaceutical Logistics 101: Characteristics and Case Studies

1. Characteristics of Biopharma Logistics Pharmaceuticals can largely be classified into two groups: synthetic pharmaceuticals and biopharmaceuticals. Synthetic pharmaceuticals are drugs manufactured through chemical synthesis, and most commonly taken drugs such as high blood pressure drugs and painkillers belong to synthetic drugs. Synthetic pharmaceuticals are composed of various combinations of chemicals, characterized by their relatively small molecular size and simple structure. These drugs are developed to produce consistent effects for most people and are known to be effective to an adequate degree. Humanity has long relied on chemical drugs to manage diseases and alleviate pain. However, from the perspective of the human body, chemical drugs are foreign substances. The body continuously breaks down and expels these foreign substances through immune and metabolic processes, necessitating ongoing medication intake, which can eventually lead to drug resistance. To address these issues, biopharmaceuticals have emerged as an alternative.

Biopharmaceuticals are medicines made using raw materials (proteins) derived from humans or other living organisms using biotechnology and include vaccines, insulin, and antibody medicines. Biopharmaceuticals are composed of components derived from living organisms, characterized by their complex structures and large molecular sizes. They utilize proteins or cells sourced from humans or other organisms, resulting in lower toxicity and fewer side effects. These drugs are highly effective in targeting specific indications. However, because they are produced using living cells, the manufacturing process is intricate and costly. In addition, biopharmaceuticals selectively work on a user’s body before a disease breaks out, which makes them highly effective against intractable and chronic diseases. Thanks to this benefit, biopharmaceuticals are exerting increasing influence in the pharmaceutical market.

Biopharmaceuticals are made from organisms, which make them susceptible to damage. Damaged biopharmaceuticals lose their intended function and, in the worst-case scenario, have a critical impact on the life and health of those who use them. In particular, the need for a cold chain has been reexamined due to issues with cold distribution of the 2020 flu vaccine and COVID-19 vaccine.

The biopharmaceutical cold chain refers to a logistics system for drug temperature management throughout the entire process, including production, shipment, distribution, and administration. Biopharmaceuticals require management of not only low temperature conditions but also humidity control, shock prevention, and light exposure prevention.

Numerous countries and pharmaceutical associations have been ramping up regulations to ensure the safety of biopharmaceuticals distributed in the market. The wide range of regulations and certifications include the European Union’s GDP Guidelines, the United States’ FDA GDP Guidelines and DSCSA, Korea’s KGSP, WHO’s pharmaceutical regulations, and the IATA’s CEIV Pharma Certification. Anyone who handles biopharmaceuticals is required to obtain and comply with these strict certifications and regulations, while maintaining compliance with the conditions required for each specific product.

It is a daunting task to maintain the right temperature and humidity throughout the entire logistics process, from inland transportation and warehousing to international transportation, and it is difficult to satisfy the myriad regulations and conditions during this time. The traditional biopharmaceutical cold chain consists of commercialization technology based on a passive temperature control system and logistics technology such as refrigerated transportation. Pharmaceutical products are packaged with dry ice and special packaging materials after attaching a temperature sensor, and are transported through refrigerated containers and refrigerated warehouses. Distribution process management uses methods such as having the person in charge scan a barcode to check compliance with the specified temperature, or tracking the distribution process via email and phone. 2. Case Study for Biopharma Logistics: Ocean Transport of Frozen Human Blood Plasma for Company P Blood products are medicines made from blood, and are manufactured in the form of medicines such as albumin and immunoglobulin by fractionating and purifying the components in the blood. Blood products are used as essential treatments in various fields such as shock caused by excessive bleeding, congenital immunodeficiency disease, and hemophilia. In national disaster situations, blood products such as albumin and immunoglobulin are widely needed, so they are designated and managed as national essential medicines. there is.

The Singapore government has been promoting a project to procure blood products in the form of a national tender and supply them to its citizens. P, a company specializing in blood products, was selected as the first Asian country to produce all of the volume supplied by the Singapore Health Sciences Authority in 2021 in the national tender for blood products by the Health Sciences Authority (HSA) of Singapore. Company P will exclusively supply blood products worth a total of 30 million Singapore dollars (about KRW 29 billion) for up to 6 years, starting with the initial export in the fourth quarter of 2023. When Singapore's health authorities supply plasma obtained through the country's blood source to Company P, Company P produces finished blood products such as albumin using plasma as a raw material at its Andong plant and sends them to Singapore.

Samsung SDS was in charge of the project to transport plasma from the Singapore health authorities to P's Andong factory. The scope of this project was to perform PTI in Singapore, perform inland transportation, transport by sea from Singapore to Busan, and then perform inland transportation at the destination country, Korea. Since it is transported a relatively short distance from Singapore to Busan, the possibility of issues with the Reefer Container is low, but it was essential to maintain the product temperature throughout the entire section from departure to destination at -35℃.

[1] PTI (Pre Trip Inspection): A term meaning pre-transportation work, which involves pre-testing frozen and refrigerated containers before loading cargo onto a ship at the departure point

First, Samsung SDS conducted preliminary operational consulting through a local logistics consultant in Singapore. At this stage, the Reefer Container and equipment required for transportation were secured in advance and an operation process optimized for the local environment was established. In addition, the existing standard operating procedure (SOP) was redesigned based on temperature management products to minimize the risk of temperature deviation.

At the departure point, it was necessary to manage the transportation lead time and at the same time carry out packaging/packing work that meets customer requirements and purchase and supply auxiliary materials needed for packaging. First, box and pallet packages for packaging the plasma had to be prepared one month before shipment. Additionally, to maintain temperature, we prepared about 50kg of dry ice per pallet, or about 300kg of dry ice for a total of 6 pallets. Refrigerated vehicles were also dispatched to ensure immediate transportation without delay after the packaging/packing work was completed.

For inland transportation, we secured a Magnum container that can maintain a temperature of -35°C, and performed PTI to check in advance whether there were any problems. For stable terminal operations, it was decided to utilize PSA Terminal, which has Reefer Container handling volume and extensive experience. After entering the terminal, we thoroughly performed preliminary work, such as checking again to make sure there was no damage during inland transportation and connecting the generator.

Samsung SDS uses Cello Trust, a specialized platform for biopharmaceuticals, to control the real-time location and temperature of cargo. For international transportation, you can monitor the progress of international transportation at each stage, including ATD, ETA, B/L, and location, and check the temperature history of the entire international transportation/inland transportation section.

At the destination, professional executors and equipment with Reefer Container logistics operation capabilities were secured in advance for inland transportation, and advance truck capacity was also secured considering cargo volume for stable service. In addition, a back-up operation plan has been prepared to comply with emergency delivery request dates. Above all, for temperature management, temperature deviations were checked at each designated point, and temperature abnormalities were continuously shared until entry into the factory. We also implemented a customs clearance process that took into account the characteristics of biopharmaceuticals. In preparation, we operated a timely reporting system to customers in the event of predefined abnormal situations (abnormal situations and events) to monitor cargo issues to prevent them from occurring.

For this project, the entire process of departure and destination transportation was integrated and managed through cooperation between Samsung SDS headquarters and Singapore-based experts. Through this, we were able to secure the stability of plasma transportation that needs to be kept frozen, and most importantly, we were able to achieve on-time delivery within the set project deadline. 3. Why SamsungSDS Thanks to advancements in biopharmaceutical technologies, the increase of biosimilar products replacing original products nearing patent expiration, and the surge of medical demand and cost driven by population aging, the biopharmaceutical market is expected to continue its rapid growth trajectory in the coming years. Staying ahead in the market’s escalating competition requires a stable logistics management system as well as highly effective pharmaceuticals. For a pharmaceutical company, building the infrastructure and global network for biopharmaceutical logistics requires a massive amount of investment. For this reason, it is more efficient to engage the services of a logistics service provider.

Samsung SDS is the ideal partner for biopharmaceutical logistics, characterized by eight key elements: quality management, cold chain, temperature control, security, traceability, regulatory compliance, process standardization, and customized services. The cold chain system maintains a constant temperature to prevent the deterioration of pharmaceuticals, and Samsung SDS provides cold chain solutions utilizing specialized equipment, personnel, and the latest technology. Temperature control involves continuously monitoring to maintain the proper temperature. Samsung SDS employs IoT-based temperature monitoring and a standardized platform to manage and track this in real-time.

With extensive experience in logistics and IT services, Samsung SDS operates top-level security systems to protect high-value pharmaceuticals and provides customized services, including integration with customer systems like ERP. Additionally, specialized SOPs for biopharmaceuticals ensure compliance with stringent regulations and laws across different countries, enabling consistent operations. Samsung SDS's rigorous quality management system guarantees the efficacy and safety of biopharmaceuticals

In recognition of these outstanding logistics operation systems and technologies, Samsung SDS was awarded the Certification for Air Transportation of Pharmaceuticals (CEIV Pharma) by the International Air Transport Association (IATA) in January 2024. The CEIV Pharma Certification issued by the IATA is a global standard certification granted to companies that have satisfied around 280 strict criteria related to pharmaceutical transportation processes, including meticulous temperature control; operation of specialized management personnel; quality control systems; and compliance with international regulations. With the acquisition of the CEIV Pharma Certification, Samsung SDS assures that the products of pharmaceutical companies will be handled with the utmost care and processed in accordance with the highest industry standards.

The biopharmaceutical market has once again captured global attention in the wake of the pandemic. With over 10 years of accumulated expertise and experience, Samsung SDS provides logistics services in 36 countries worldwide and is a trusted logistics partner in the biopharmaceutical market. Leveraging its excellent logistics infrastructure, global network, advanced logistics platform Cello, and cutting-edge technologies like IoT and AI, Samsung SDS offers differentiated logistics services to its customers. Samsung SDS will continue to pursue innovation and improvement, looking forward to growing together with pharmaceutical companies aiming to enter the global biopharmaceutical market.

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