Issue link: https://www.e-digitaleditions.com/i/1450659
28 Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 P h a r mTe c h . c o m Manufacturing T he COVID-19 pandemic highlighted the potential of an array of modalities within the biopharmaceu- tical industry. In particular, the success of messen- ger RNA (mRNA)-based COVID-19 vaccines has encouraged biopharmaceutical companies to explore and utilize these technologies for other diseases and look to rap- idly expand their capacity and capabilities in response to an upsurge in demand. At the end of 2019, the combined market capitalization of the five publicly listed companies focusing on mRNA plat- forms was $15 billion (€13.1 billion), and as of August 2021, that value of capitalization reached more than $300 billion (€262 billion) (1). This significant boost in market valua- tion ref lects the optimism that mRNA technology can de- liver much more and go beyond the current prophylactic COVID-19 vaccines. Preparation for this new wave of technology brought new challenges. The continued growth of biologics pipelines mag- nified limitations in internal manufacturing capacity, driving drug developers to partner with contract development and manufacturing organizations (CDMOs) to enlarge the man- ufacturing network. CDMOs needed to expand capacities and facilities to serve the dynamic market changes. More robust technologies and cold chain capabilities had to be offered to meet the demand too. By increasing capacity and preparing for the multi-modali- ties of new technologies, CDMOs have put themselves in good stead for new therapeutics on the horizon, such as mRNA treatments targeting advanced cancers and heart disease. 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 technologies were slow to advance and there was little investment into the area. James Park is executive vice-president and managing director of the Global Sales Center at Samsung Biologics. MAKS_L AB - STOCK.ADOBE.COM Preparing for the Future: Expanding Capacity and Facilitating Multi-modalities James Park CDMOs need to consistently demonstrate agility as demand increases for newly developed therapeutic modalities.