How CDMOs are adapting to the new mRNA technological demands

From 2020, with the outbreak of COVID-19, there has been a steady increase in the demand for new technologies like messenger RNA (mRNA). Contract Development and Manufacturing Organizations (CDMOs) are forced to rapidly expand capacities to meet this boom. Let us see how CDMOs have prepared for the new wave of technologies on the horizon, and the challenges they have faced in welcoming a new era of such technologies.

The COVID-19 pandemic highlighted the successful development and use of mRNA vaccines. This has encouraged biopharmaceutical companies to explore and use these technologies for other diseases. There are many new therapeutic programs based on mRNA and lipids, which are encouraging CDMOs to invest in new expertise to deliver complete solutions.

CDMOs are building new capacity, as well as building capacities, to better prepare for the new wave of technologies. Many CDMOs have invested in new processes and resources to protect product integrity, reduce waste, and deliver safe and effective supplies to patients without delay.

“In the area of ​​mRNA technology, we have seen CDMOs build almost exclusive internal ones, while others are making strategic acquisitions to develop their mRNA capabilities. Many CDMOs, such as the Center for Breakthrough Medicine, use this dedicated and separate capability. This is extraordinarily complex and CDMO is a separate process from other processes currently running, so you should make sure to isolate these tasks as much as possible from your current build. Jorge Ahlgrim, President and CEO, Center for Breakthrough Medicine, U.S.

With mRNA-based drugs increasing in popularity over such a short time frame, the companies supporting their development and manufacture had to adapt quickly as mRNA-based vaccines required cold chain capabilities and more robust aseptic fill-finish technologies. it occurs.

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Even though COVID-19 fueled the growth of the CDMO market, it also brought its fair share of challenges. Management of supply chains was perhaps the biggest challenge as the pandemic had a sudden and extreme impact on the supplier/distributor network.

“This challenge calls for rapid, yet accurate, expansion of clinical supply chains, which will need to be informed by data and expertise and underpinned by global infrastructure and networks,” it said. Kevin Cheong, Director, Clinical Operations-Asia, Almac Clinical Services, UK, Kevin is based in Singapore.

As mRNA-based technology is a new approach in the industry, some CDMOs have extensive experience and a historical track record to point to. However, CDMOs with teams of scientists specializing in the field can mediate challenges and more quickly address the growing mRNA market.

“The mRNA-based technology challenges are not necessarily unique. All cell and gene manufacturing technologies have faced obstacles that need to be overcome. That said, for mRNA I see these two challenges. The first construct Or gain the ability to scale up manufacturing, as well as be able to source high quality mRNA synthesis. The other is mastering and being able to replicate the technology process, which is a key element to having a successful CDMO. It is,” said George.

During the pandemic, production capacity and yields had to be increased dramatically, which came with obvious challenges. “Efficiency is another obstacle to DNA and plasmid production, a process that utilizes fermentation with E. coli. Suit dedication is a major issue because of carrying out the fermentation process in a suite that also runs a mammalian cell culture.” , which can lead to a risk of cross-contamination. As a result, alternative manufacturing platforms such as synthetic plasmid DNA (dog bone) may rise to prominence,” said Lawrence Yap, Global Head, Technical Operations, Hillman Laboratories, Singapore,

The unique nature of mRNA also creates analytical challenges in drug development. It is important to remember that mRNA technology itself is rapidly advancing and evolving on an ongoing basis. Developers of analytical methods for mRNA therapeutics and vaccines are therefore challenged not only by the complexity of these biomolecules and their delivery vehicles, but also by the need to develop flexible methods that operate in mRNA structures and final formulations. Can accommodate changes.

“There is also the analytical challenge to identify suitable tests that can monitor the quality of each intermediate. This requires highly specialized assays and analytical testing to properly characterize the molecule, and select the most appropriate formulation, which may involve lipid nanoparticle fabrication,” Lawrence said.

Lack of skilled workforce is another bottleneck. CDMOs require highly technically skilled talent for development, production and testing of each mRNA-based unit. “It has been challenging to find talent that can support rapid manufacturing in manufacturing, analysis, manufacturing science and technology (MST), technology transfer and chemistry, and manufacturing and control (CMC). We see a growing demand for those talents. We are looking for someone who has the skill set and in-depth knowledge in the microbial fermentation and biocatalytic enzymatic synthesis process,” Lawrence said.

lessons Learnt

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The pandemic and the resulting rapid approval of vaccines have highlighted the industry’s ability to move through the drug development process far more rapidly than was ever thought possible. It also shows the importance and power of strategic cooperation.

“One of the most important lessons we learned about preparing for the future stems from our experience with COVID-19 vaccines. It is clear that both innovator companies and CDMOs, with the right amount of public support, can develop a product and bring it to market very quickly. That said, all the stars were aligned. Every government and health agency wanted a rapid-fire solution – a product that worked and worked safely, so the usual barriers to fast-tracking a product to market were eliminated.,Jörg said.

Another important lesson is having strong supply chain management processes. “One of the lessons to be learned is in supply chain management to avoid disruptions. Manufacturers must ensure that there is always a reliable supply of raw materials and consumables. At the same time, we need to identify potential sources of equipment and consumables as alternative options in the event of delays from their primary source,” Lawrence said.

Contract manufacturers are now evolving into the area of ​​contract research and manufacturing services (CRAMS), becoming important partners for pharma players in every sense of the word. “The model involves working with contract research organizations (CROs) to generate data supporting the route to clinic entry, followed by partnership with an innovator to provide resources for drug development.” The small biotech-innovator relationship would ideally turn into a tripartite agreement, where the execution component would come from an integrated service provider (CRO-CDMO) with end-to-end capabilities. Dr. Mahesh Bhalgat, COO, Syngene International, India,

Much of what CDMOs can achieve during this crisis is also due to technology and digitization of the development and manufacturing process, and going forward technology will play an even more important role in the functioning of CDMOs.

The challenges faced by the sector during the pandemic highlighted how important it is to be agile and resilient to ensure consistent and cost-effective delivery. CDMOs that demonstrated agility and ability to respond to changes in market dynamics, as well as adapt their manufacturing capabilities to new technologies, are best suited for the future.

Ayesha Siddiqui

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