Issue link: https://www.e-digitaleditions.com/i/1499694
28 BioPharm International ® Partnerships for Outsourcing eBook May 2023 www.biopharminternational.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 technology space has quickly expanded. This is reflected in the global mRNA vaccines and therapeutics market, val- ued at $54.37 billion in 2021 (2). The ability of the biopharma industry to meet the worldwide demand for mRNA vaccines was facilitated by contract development and manufacturing organi- zations (CDMOs). These partners 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 provides a perspective on the strategies and tactics 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 biologic drug development and manufacturing. Particular emphasis was placed on the need for cold chain capabilities 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 considerable time ensuring product stability in all development stages, further truncating timelines. This shift of focus increased pressure for additional and specialized capabilities. Preparing for a New Wave of mRNA Technologies Jeong Jin-hyeok is principal scientist in drug product at Samsung Biologics. To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities. BILLIONPHOTOS.COM - STOCK.ADOBE.COM