Issue link: https://www.e-digitaleditions.com/i/1492687
30 Pharmaceutical Technology ® Bio/Pharma Outsourcing Innovation eBook 2023 PharmTech.com BILLIONPHOTOS.COM - STOCK.ADOBE.COM F ollowing the initial onset of the COVID-19 pandemic, the biopharma industry rapidly reacted, accelerating research surrounding a groundbreaking drug modality: messenger RNA (mRNA) vaccines. With more than 12.1 billion people globally receiving a shot since approval of the first COVID-19 vaccine (1)—Pfizer–BioNTech's mRNA vaccine, it is no surprise that the mRNA tech- nology space has quickly expanded. This is reflected in the global mRNA vaccines and therapeutics mar- ket, valued at $54.37 billion in 2021 (2). The ability of the biopharma industry to meet the worldwide demand for mRNA vaccines was facili- tated by contract development and manufacturing organizations (CDMOs). These par tners promptly adapted their facilities and capabilities specifically for vaccine production, offering contract fill/finish and cold chain services required to meet demand. Examining the lessons learned, this article pro- v ides a perspect ive on t he st rategies a nd tact ics taken to deliver a better drug development program and highlights the importance of remembering key lessons as the industry moves toward an era of new drug modalities. Supporting pandemic production needs The explosive demand for treatments and vaccines for COVID-19 drove the dramatic rise in the volume of bio- logic drug development and manufacturing. Particular emphasis was placed on the need for cold chain capabil- ities and fill/finish processes to support mRNA projects. The onset of the pandemic also contributed to the demand for accelerated project delivery times to bring treatments and vaccines to Phase I and Phase II clinical trials sooner. Manufacturers often opted to depend on cold chain capabilities as opposed to spending Preparing for a New Wave of mRNA Technologies Jeong Jin-hyeok is a lead specialist in drug product at Samsung Biologics. To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.