BioPharm International - May 2021

BioPharm - Partnerships for Outsourcing - May 2021

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8 BioPharm International eBook May 2021 RNA's Expanding Horizons As the RNA therapeutic market grows, contract manufacturing services for GMP-grade RNA are in demand and expected to continue on an upward trajectory. S ince the commercialization of an antisense oli- gonucleotide and subsequent R NA aptamer therapies in the late 1990s and early 2000s, respectively (1), a diverse set of R NA-based drugs that tackle wide ranging therapeutic needs have emerged in development. Most recently, two messen- ger RNA vaccines for COVID-19 have received emergency use approval by global regulatory bodies, representing a milestone success, according to topical commentary (2). The successes of such therapies are being ref lected in the potential growth of the RNA therapeutics market, which is expected to be strong in the near future with some market analysts estimating its worth at $2612.11 million by 2025 (3). Inevitably, market growth is spurred by an increase in demand, which in turn is giving rise to more opportunities for contract manufacturing organizations to service the sector. To d i s c u s s R N A c o n t r a c t m a n u f a c t u r i n g s e r- vices in more detail, BioPharm International spoke with David R icketts, director of Business Development for Manufacturing Services, and Bernard Sagaert, chief oper- ational officer, both at eTheRNA immunotherapies NV—a company that extended its RNA contract manufacturing services in November 2020 to meet growing demand (4). EXPECTATIONS AND PROCESSES BioPharm: Could you prov ide more detail on what is involved in and expected of good manufacturing practice (GMP) RNA contract manufacturing services? Ricketts (eTheRNA): Any group developing a thera- peutic product or vaccine that includes RNA as a drug substance w il l need the R NA to be manufact ured to GMP standards. The overall process for manufacture of research grade or GMP grade is similar, but GMP FELICITY THOMAS Partnerships for Outsourcing Manufacturing CROCOTHERY -

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