There are two types in pharmaceuticals: synthetic pharmaceuticals and biopharmaceuticals. According to the Industry and Overseas Investment Research Office of the Export–Import Bank of Korea, the global pharmaceutical market will grow at a yearly rate of 6 percent, reaching USD 1.5 trillion by 2021.
This white paper explains the characteristics of logistics services for biopharmaceuticals, high-value-added products that require an equally high level of logistics capabilities. It also takes a look at technologies required for stable logistics operation.
Characteristics of Biopharmaceuticals
What are Biopharmaceuticals?
Pharmaceuticals can largely be classified into two groups: synthetic pharmaceuticals and biopharmaceuticals And biopharmaceuticals are further broken down into gene-spliced proteins, cell therapeutics, gene therapeutics, blood products, and vaccines.
Characteristics of Biopharmaceutical Logistics
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. This worst-case scenario became a reality in Shanxi, China in 2013, when four children died and seventy others went into a coma or suffered severe disorders after being injected with a hepatitis B vaccine stored and transported at high temperatures. The incident became a serious social issue in that country.
To prevent similar accidents, 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,1) the United States’ DSCSA,2) Korea’s KGSP,3) WHO’s pharmaceutical regulations, and the IATA’s CEIV Pharma Certification.4) 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.
Also, biopharmaceutical logistics requires maintaining optimal temperature and humidity throughout the long and complicated transportation process. 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.
Furthermore, customers should be provided with temperature and humidity information in real time so that they can monitor the condition of their products. In particular, an alarm system should be in place to ensure immediate response to a possible temperature abnormality by alerting the parties concerned through text messages, emails, and other channels.
1) GDP Guidelines: Good Distribution Practice Guidelines
2) DSCSA: Drug Supply Chain Security Act
3) KGSP: Korean Good Supplying Practices
4) CEIV Pharma Certification: Certification issued by the Center of Excellence for Independent Validators in Pharmaceutical Logisticsof the International Air Transport Association (IATA)
Cello-Based Biopharmaceutical Logistics Operations
Cello WMS + IoT: Warehouse Monitoring and Micro Mgmt.
If products are damaged due to improper storage management, the company fails to meet customer orders and loses sales opportunity. It also results in a situation where most products must be disposed of and restocked with urgently produced replacements. Samsung SDS maintains the quality of biopharmaceuticals at the highest level by micro-managing their temperature, humidity, and aging data during storage. This feat is achieved by the combination of IoT technology and Cello Warehouse Management System (WMS), which is Samsung SDS’ own warehouse management system.
First, Cello WMS uses IoT technologies to control the temperature and humidity of each warehouse area. It monitors the temperature and humidity of each area in real time and alerts the relevant personnel of any issue for rapid response.
Furthermore, the system divides the inventory into small groups by item, lot, bin, or customer (consumer) based on the shipper’s (supplier’s) requirements, and manages each item in accordance with the applicable storage standards. Cello ensures impeccable quality control and stable supply of products by tracking the inventory history all the way down to single items during receiving, storage, shipment, and other processes performed in a warehouse.
Cello TMS + IoT: Transportation Monitoring and Performance Mgmt.
Cello Transportation Management System (TMS) uses IoT technology and provides various information on pieces of cargo from the moment when they are loaded until they arrive at their final destinations. The information provided includes temperature and humidity, vehicle locations and routes in real-time, and vehicle and container’ open/closure status.
Such information allows for immediate identification and response in case of situations that may damage the products, such as abnormal temperatures or humidity or prolonged vehicle standby during transport. It can also alert of possible theft indicated by a deviation from the intended route or an unauthorized opening/closure of a vehicle.
The system is also connected to drivers’ mobile devices through Cello Mobile TMS for real-time management of arrival/departure times at each destination, delivery completion reports, and accident/delay reports. Based on the likelihood of predicted issues and the real-time information reported from drivers, the system is capable of ensuring immediate actions are taken as needed, such as the dispatching of an emergency vehicle or sending products to a nearby temporary storage, thereby minimizing product loss.
Staying ahead in the market’s escalating competition requires a stable logistics management system as well as highly effective pharmaceuticals. Biopharmaceuticals should be handled in compliance with special management standards and regulations designed to ensure their safety, which provide for detailed requirements for temperature control, special packaging, transportation, and storage.
Therefore, companies need the logistics capabilities and infrastructure required to comply with and manage these requirements. They should be capable of maintaining their products in their best conditions during transportation and storage by ensuring precise temperature and humidity control, which should be monitored in real time around the clock. In addition, to successfully compete in the global market, companies need to secure a network capable of providing the same level of logistics management on the global level.
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. As a trustworthy partner for pharmaceutical companies who have set their eyes on the global market, Samsung SDS combines its logistics infrastructure and global network, the specialized solutions for logistics processes such as WMS and TMS, and state-of-the-art IoT technology to satisfy pharmaceutical companies’ needs for biopharmaceutical transportation.
To find out more about Biopharmaceutical Logistics of Samsung SDS, visit Cellologistics.com and download the white paper.