What Makes a Great CDMO Partner for mRNA Vaccine Production? Experts at Samsung Biologics Explain
During the COVID-19 pandemic, contract development and manufacturing organizations (CDMOs) saw an increase in demand as pharmaceutical companies looked to adjust supply chain issues by working with outside partners. In addition to this general increase in demand, the pandemic introduced novel demand for mRNA vaccine production, when mRNA COVID-19 vaccines became the first mRNA vaccines approved for human use.
As mRNA vaccine technology develops, CDMOs that have adapted their processes to produce COVID-19 mRNA vaccines will look to remain equipped to handle the expected introduction of a variety of mRNA therapeutics and vaccines for future applications outside of COVID-19.
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Samsung Biologics, one of the world’s largest CDMOs, partnered with Moderna for the mRNA vaccine production of its COVID-19 vaccine, providing fill/finish services. The CDMO has since expanded its mRNA vaccine production capabilities, adding drug substance services as part of an end-to-end mRNA suite.
According to CEO John Rim, the CDMO has made portfolio diversification one of the three pillars of a multidimensional growth plan, and expanded mRNA capabilities look to be a central component of the company’s diversification plan.
In a recent Q&A, two leaders of the company’s mRNA activities — executive vice president and head of manufacturing Pierre Catignol and lead scientist of mRNA manufacturing Huisub Lim — explained Samsung Biologics’ approach as a CDMO partner for mRNA vaccine production, outlining which characteristics partners look for in a CDMO, as well as the broader benefits and obstacles involved in producing mRNA vaccines.
“CDMO competition can be expected to intensify since mRNA manufacturing capacity and CDMOs’ capabilities both expanded significantly to meet the need associated with the pandemic,” said Catignol and Lim. “Additionally, many larger pharmaceutical companies now have added in-house capability. This paradigm demands that CDMOs add value beyond capacity to stand out as optimal partners.
Experience and End-To-End Expertise
According to Catignol and Lim, two of the most important criteria clients look for in a CDMO partner for mRNA vaccine production are experience and the ability to handle all aspects of the process, from drug substance to drug product services, at a single facility for a variety of production scales.
“From a technical standpoint, the processes associated with mRNA manufacture generally are still new; this is pioneering work. Thus, it is vital to work with a partner that has experience with IND [investigational new drug] filings for both mRNA-based vaccines and therapeutics. CDMOs with experience in IND filing are able to guide customers through areas of focus and can help to set management standards for approval, ensuring the product will not face an undue risk of harm.”
Catignol and Lim emphasized that, in addition to this IND experience, an ideally equipped CDMO partner should be able to provide end-to-end mRNA vaccine production services for clients. On the drug substance side, this includes the linearization and transcription of pDNA (plasmid DNA) for in vitro synthesis of mRNA molecules. The process then involves purifying mRNA through chromatography and ultrafiltration, followed by capping and lipid nanoparticle (LNP) encapsulation to ensure stability. CDMOs must also provide cold storage for the mRNA drug substance, with Samsung Biologics utilizing storage systems with temperatures as low as minus 70 degrees Celsius.
The drug product aspects of mRNA vaccine production include aseptic fill/finish services that transfer the mRNA to a vaccine vial while ensuring a lack of contamination, as well as labeling and packaging services.
With the construction of an end-to-end mRNA suite that can complete all of these processes at a single facility, Samsung Biologics sought to both mitigate the risk of degradation from transportation and provide a seamless mRNA vaccine production process for partners.
“Few manufacturers/CDMOs are adequately equipped or capable of carrying out all manufacturing steps, leading to logistical, monetary, and time line difficulties. Frequent handling of mRNA across multiple locations increases contamination and degradation risks,” said Catignol and Lim. “When the entire work stream is coordinated by one partner from a single location, transitions across development and production tasks run smoothly, maximizing efficiency and mitigating potential risks.”
MRNA Vaccine Production and Other CDMO Capabilities
In a Drug Development & Delivery roundtable with pharmaceutical industry executives and scientists, Lim explained that expanding capabilities as an mRNA vaccine production partner can potentially help CDMOs in other areas, including cell line and gene therapies.
When asked which trends will have the most impact on pharmaceutical manufacturing in 2022, Lim explained that CDMOs that embraced the challenge of quickly supporting mRNA vaccine production will be better equipped with the agility to adapt both to new applications of mRNA and other innovative biopharmaceutical technologies.
After noting efforts to develop mRNA therapeutics and vaccines for applications ranging from cancer to HIV, Lim explained that CDMOs with enhanced mRNA capabilities and the ability to remain flexible will be well positioned to partner with companies working on more innovative biopharmaceuticals.
“Despite the difficulties associated with supporting the manufacturing of this relatively new and unfamiliar technology, some CDMOs rose to the challenge and embraced the learning curve. They balanced the needs of these new projects with those ongoing by expanding their facilities and capabilities,” said Lim. “As a result, these CDMOs are now better placed than ever to support emerging technologies, including cell and gene therapies (C>s). Their experience pivoting to accommodate new processes and optimize them will go hand in hand with their increased capacity to smoothly scale C> manufacturing and development to commercial sizes in future.”
While mRNA vaccine production looks to be a significant component of Samsung Biologics’ portfolio diversification strategy, it remains to be seen how the CDMO’s expanded mRNA capabilities will relate to other diversification efforts down the line.
Samsung Biologics has remained focused on mRNA in recent months, demonstrating the capabilities of its new end-to-end suite with the completion of the first commercial-scale manufacturing run of an mRNA vaccine production partnership with GreenLight Biosciences. The run, which was completed earlier this year, completed a scale-up from technology transfer to commercialization of GreenLight’s COVID-19 vaccine candidate in approximately seven months, demonstrating the potential for quick manufacturing scale-ups of mRNA technology through a CDMO partnership.
Author: Digital Solutions
