Kristin Brooks, Managing Editor03.01.21
With Johnson & Johnson’s candidate becoming the third COVID-19 vaccine to receive Emergency Use Authorization from the FDA, following Pfizer-BioNTech and Moderna, the focus shifts to supply chain logistics and the continued vaccination of millions of people. All three vaccines require cold-chain technologies, which present transportation challenges.
Pfizer-BioNTec’s vaccine must be kept at -70°C (-94°F) and once transferred to a refrigerator, it must be administered within five days. Moderna’s vaccine must be shipped at -20°C (-4°F), and can be stored at that temperature for six months. Once thawed and refrigerated between 2 - 8°C (36 - 46°F), it’s good for up to 30 days. J&J’s vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months refrigerated at temperatures of 36 - 46°F (2 - 8°C).
Cryoport, a provider of cryogenic logistics for life sciences companies, supports 517 active clinical trials globally, including several COVID vaccines and treatments, and multiple cell / gene therapies in commercial distribution.
Cryoport works with Gilead / Kite, Amgen, Celgene, bluebird bio, Novartis and other top biopharma companies around the world. Cryoport is the sole temperature-controlled logistics provider for Novartis’ Kymriah and Gilead / Kite’s Yescarta. It is also the logistics provider for bluebird bio’s Zynteglo.
Mark Sawicki, Ph.D., CEO of Cryoport Systems discusses how the pandemic is reshaping the pharmaceutical supply chain, the hurdles and the capabilities needed to overcome them. – KB
Contract Pharma: How is the pandemic reshaping the pharmaceutical supply chain?
Mark Sawicki: Initially, the pandemic caused a lot of companies to adjust their supply chains on the fly. This was evident by the number of temporary suspensions on clinical trial activity. Now that we are about a year into it, most companies have adjusted and are now looking for new, better ways to back up or bullet-proof all aspects of their systems. Trial activity has also returned to pre-COVID levels.
For Cryoport, we first had to make sure that we took care of our global employees by implementing processes and equipment to try and keep everyone virus-free. By now, we are all used to masking up, socially distancing and washing our hands frequently. And, of course, there are a lot of employees who are still working remotely and expected to continue doing so for much of 2021.
Beyond the impact on employees, the supply chains have had to adjust to the reduced amount of air cargo capacity, shortage of bio-storage capacity brought on by vaccine production, travel restrictions and some boarder closings.
CP: What are the greatest supply-chain hurdles that clients face, and how can they be overcome?
MS: The lack of air cargo capacity due to commercial flight reduction has been well-documented and remains a significant issue. Rates have increased by as much as 107 percent for some routes over 2019 and are likely to remain elevated through mid-2022.
Companies have adjusted by implementing alternative transportation methods and expanding their list of approved freight providers, as well as moving away from just-in-time methodologies.
CP: What are some of the latest capabilities needed?
MS: Bio-storage and contract manufacturing facilities across the world have been expanding their capacity in advance of cell and gene therapies’ progression. However, some of the COVID-19 vaccines require ultra-cold storage, and there remain large parts of the world without the storage infrastructure necessary to handle them.
This has resulted in a scramble to buy and install industrial freezers globally. Additionally, contract manufacturing is heavily engaged with vaccine manufacturing and, in many cases, new programs are experiencing delays.
CP: How has the pandemic impacted clinical trial management needs?
MS: There was a shortage of cell and gene manufacturing capacity going into the pandemic, and it has gotten worse with the significant demand for COVID-19 mRNA vaccine manufacturing. We anticipate delays in new clinical starts, particularly for allogeneic programs that utilize batch manufacturing, which would seem to compete for capacity with vaccine production.
The good news is that, despite the above, we expect to see up to 23 biologics license applications, as well as marketing authorization application filings in the cell and gene therapy space in 2021, albeit some of them may push out to 2022 due to the U.S. Food and Drug Administration’s (FDA) focus on getting COVID-19 vaccines approved for the global population.
Mark Sawicki, Ph.D., is Cryoport Systems' CEO. Dr. Sawicki brings 15 years of business development and sales management experience to the company. He was most recently the chief business officer at AAIPharma Services Corporation / Cambridge Major Laboratories Inc. Additionally, he served in senior business development roles at CMC Biologics and Albany Molecular Research Inc. Dr. Sawicki has authored a dozen scientific publications in drug discovery with a focus on oncology and immunology.
Pfizer-BioNTec’s vaccine must be kept at -70°C (-94°F) and once transferred to a refrigerator, it must be administered within five days. Moderna’s vaccine must be shipped at -20°C (-4°F), and can be stored at that temperature for six months. Once thawed and refrigerated between 2 - 8°C (36 - 46°F), it’s good for up to 30 days. J&J’s vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months refrigerated at temperatures of 36 - 46°F (2 - 8°C).
Cryoport, a provider of cryogenic logistics for life sciences companies, supports 517 active clinical trials globally, including several COVID vaccines and treatments, and multiple cell / gene therapies in commercial distribution.
Cryoport works with Gilead / Kite, Amgen, Celgene, bluebird bio, Novartis and other top biopharma companies around the world. Cryoport is the sole temperature-controlled logistics provider for Novartis’ Kymriah and Gilead / Kite’s Yescarta. It is also the logistics provider for bluebird bio’s Zynteglo.
Mark Sawicki, Ph.D., CEO of Cryoport Systems discusses how the pandemic is reshaping the pharmaceutical supply chain, the hurdles and the capabilities needed to overcome them. – KB
Contract Pharma: How is the pandemic reshaping the pharmaceutical supply chain?
Mark Sawicki: Initially, the pandemic caused a lot of companies to adjust their supply chains on the fly. This was evident by the number of temporary suspensions on clinical trial activity. Now that we are about a year into it, most companies have adjusted and are now looking for new, better ways to back up or bullet-proof all aspects of their systems. Trial activity has also returned to pre-COVID levels.
For Cryoport, we first had to make sure that we took care of our global employees by implementing processes and equipment to try and keep everyone virus-free. By now, we are all used to masking up, socially distancing and washing our hands frequently. And, of course, there are a lot of employees who are still working remotely and expected to continue doing so for much of 2021.
Beyond the impact on employees, the supply chains have had to adjust to the reduced amount of air cargo capacity, shortage of bio-storage capacity brought on by vaccine production, travel restrictions and some boarder closings.
CP: What are the greatest supply-chain hurdles that clients face, and how can they be overcome?
MS: The lack of air cargo capacity due to commercial flight reduction has been well-documented and remains a significant issue. Rates have increased by as much as 107 percent for some routes over 2019 and are likely to remain elevated through mid-2022.
Companies have adjusted by implementing alternative transportation methods and expanding their list of approved freight providers, as well as moving away from just-in-time methodologies.
CP: What are some of the latest capabilities needed?
MS: Bio-storage and contract manufacturing facilities across the world have been expanding their capacity in advance of cell and gene therapies’ progression. However, some of the COVID-19 vaccines require ultra-cold storage, and there remain large parts of the world without the storage infrastructure necessary to handle them.
This has resulted in a scramble to buy and install industrial freezers globally. Additionally, contract manufacturing is heavily engaged with vaccine manufacturing and, in many cases, new programs are experiencing delays.
CP: How has the pandemic impacted clinical trial management needs?
MS: There was a shortage of cell and gene manufacturing capacity going into the pandemic, and it has gotten worse with the significant demand for COVID-19 mRNA vaccine manufacturing. We anticipate delays in new clinical starts, particularly for allogeneic programs that utilize batch manufacturing, which would seem to compete for capacity with vaccine production.
The good news is that, despite the above, we expect to see up to 23 biologics license applications, as well as marketing authorization application filings in the cell and gene therapy space in 2021, albeit some of them may push out to 2022 due to the U.S. Food and Drug Administration’s (FDA) focus on getting COVID-19 vaccines approved for the global population.
Mark Sawicki, Ph.D., is Cryoport Systems' CEO. Dr. Sawicki brings 15 years of business development and sales management experience to the company. He was most recently the chief business officer at AAIPharma Services Corporation / Cambridge Major Laboratories Inc. Additionally, he served in senior business development roles at CMC Biologics and Albany Molecular Research Inc. Dr. Sawicki has authored a dozen scientific publications in drug discovery with a focus on oncology and immunology.
