An industry review of the pharmaceutical supply chain reveals that 40% of the industry’s R&D pipeline is biologics. The biopharmaceutical supply chain is shifting away from primary care to specialty products and personalized medicines, and from large scale production of low-value small molecules to low-volume production of high-value biologics. These shifts are adding levels of manufacturing and supply chain complexity that demand laser focus on resilience and agility across the entirety of the supply chain. Market place disruption has and will continue to occur, and robust, holistic packaging engineering strategies can assist in a company’s mission to alleviate suffering and get patients the products they need.
The production and distribution of novel biologics, specialty products and personalized medicines, such as autologous oncology therapies present unique supply chain requirements.
Some of these unique requirements are listed below:
- Cold chain systemic control from plant to patient and, in CAR-T therapies, temperature control at cryogenic temperatures.
- Supply chain security to ensure data provenance block chain technologies and Internet of Things (IoT) for temperature monitoring, utilizing real time track and trace data for rapid problem solving, performance history and reverse logistics. Supply chain security is also characterized as maintenance of the chain of custody to ensure a “patient centered” supply chain—getting a shipment delivered to a specific patient.
A “patient centered” supply chain that ensures timely delivery of an autologous oncology therapy is a challenge that a skilled, life sciences packaging engineer, with a dedicated team of professionals, can embrace and solve for those companies involved in the cell and gene therapy sector of the biopharmaceutical industry.
Cold Chain Shipping Design and Qualification
For CAR-T therapies, shipping at cryogenic temperatures, those below (-) 150° C, requires the use of liquid nitrogen vapor in a contained system called a dewar. These dewars are a vacuum vessel with a pressure control system. There are several regulations governing the use and shipment of liquid nitrogen dewars, such as US DOT 49 CFR, IATA Dangerous Good and UN1977. There are a few specialty cryogenic shipping solution providers, and it is strongly recommended to partner with these providers to ensure all appropriate and necessary systems and processes are executed. Label performance qualification at cryogenic temperatures is a typical packaging engineering activity that requires the technical acumen and experience of a qualified professional.
Supply Chain Security
In order to deliver lifesaving therapies to a specific patient, high value CAR-T therapies require zero disruptions in the supply chain. To ensure data provenance for chain of custody and temperature control monitoring, real time track and trace technologies are indicated. There are several solution providers for real time track and trace—Sendum PT300 is an example of a package tracker that provides real time GPS location, temperature reading, humidity, shock events and more. The Sendum package tracker utilizes Findum software for real time monitoring with software that is 21 CFR part 11 compliant. Identifying, qualifying, and implementing appropriate technologies and solution providers to ensure supply chain security are programs that can be executed by a qualified packaging engineering and logistics expert.
The growth of the specialty biopharmaceutical market sector and its therapies for life threatening diseases and unmet patient needs has generated new and significant challenges to the pharmaceutical supply chain. From a packaging engineering perspective, cryogenic temperature shipments and supply chain security with real time track and trace requirements, are two of the challenges that can be managed with robust and agile solutions that are executed with the support of an experienced life sciences packaging engineer at Network Partners.
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