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26 BioPharm International May 2022 eBook www.biopharminternational.com cold chain capabilities had to be offered to meet the demand too. By increasing capacity and preparing for the multi-modalities of new technol- ogies, CDMOs have put themselves in good stead for new therapeutics on the horizon, such as mRNA treatments tar- geting advanced cancers and heart dis- ease. Preparing for these advancements will ease transitions into supporting the production of cell and gene therapies (C>s), another key growth area for the industry in the future. CHALLENGES FACED BY CDMOs Prior to the past decade, mRNA tech- nologies were slow to advance and there was little investment into the area. With gradual innovations, mR NA began to be considered a safe and effi- cient therapeutic tool in vaccine devel- opment. However, it was not until recently, with the onset of the COVID- 19 pandemic, that the mRNA vaccine field quickly expanded. The need for a rapid response drove the swift adoption of these new technologies in vaccine and treatment development. CDMOs were increasingly becom- ing more heavily relied upon to support the development and manufacturing of these new drug technologies. This necessitated CDMOs to rapidly pre- pare for improvements to accommodate mRNA manufacturing and overcome any challenges they faced in an unprec- edented amount of time. Adapting existing capabilities quickly Wit h a n upsu rge in dema nd for this new wave of technology, man- u fac t u rer s needed to ma k e nec- essa r y cha nges to t hei r faci l it ies and processes for them to be optimized to the product characteristics. Cold chain capabilities had to be expanded and optimized to suit the temperature-sensitive nature of mRNA molecules. This has been achieved by investing in different types of capabil- ities, from blast rate freezers to control rate freezers, and offering a wide range of container storage types to best fit the needs of the product. The necessary standard operating procedures (SOPs) have also had to be put in place for each new storage capability. The lipid nanopa r ticles used to encapsu late the mR NA were a lso u n fa m i l ia r to ma ny ma nu fac t u r- ers that predominantly worked with water-like solutions. Time was needed to determine how the nanoparticles wou ld behave and how processing conditions could impact the character- istics of the mRNA products. Balancing new and existing projects Not only did CDMOs need to accom- modate and support COVID-19-based projects, including vaccines, but they also needed to maintain the production of other medications requiring similar facilities. Ensuring suff icient capac- ity was, therefore, one of the great- est challenges to CDMOs during the COVID-19 pandemic. Careful management was needed to avoid delays due to bottleneck pro- cesses and ensure suff icient capacity for the increased level of demand. Ba lancing these requirements a lso necessitated both f lexibility and scal- abilit y to successf ul ly suppor t the development of a wide variety of essen- tial products. Accelerating speed to market was essential Speed was essential in the deliver y of products to patients in a short time frame, especially during the COVID- 19 pandemic, and presented another challenge to manufacturers. To facil- itate speed to ma rket, reg u lator y approaches to accelerate the availability of vaccines and treatments were heav- ily relied upon. These included FDA's Emergency Use Authorization (2) and Priorit y Review (3) approaches and emergency conditional market authori- zation in the European Union (4). To successfully shorten timelines and meet capacity demand, CDMOs needed to expand facilities to offer improved sca labi l it y and increase efficiency of existing processes. This required all aspects of development and manufacturing to be highly opti- mized. Throughout this process, the high quality had to be balanced with delivering at an unprecedented speed. Managing supply chains to avoid disruptions Manufact urers had to a lso ensure t hey ma inta ined a rel iable supply of raw materia ls and consumables. Many projects, both COVID-related and not, relied on much of the same equipment, processes, and raw mate- rials. However, with the onset of the COV ID-19 pandemic, biomanufac- turers were waiting up to a year for supplies and equipment. Despite ven- dors responding to increased demand by expanding capacity, projects still took months to come online (5). Essential materials for making vac- cines were in short supply—exposing how the supply chain is reliant on only a handful of countries, and even com- Partnerships for Outsourcing Manufacturing To successfully shorten timelines and meet capacity demand, CDMOs needed to expand facilities to offer improved scalability and increase efficiency of existing processes.