Oligonucleotide Production Facilities

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The oligonucleotide industry continues to grow at a rapid pace. Given the relatively small quantities of drug substance produced compared to, for example, products at an industrial chemical manufacturing facility, one might assume only limited volumes of solvents would be required. However, solid-phase oligonucleotide synthesis (SPOS) and downstream processing of oligos uses significant quantities of hazardous materials. It takes roughly 3000–7000 L of flammable liquids to produce 1 kg of drug substance.

As oligo manufacturers scale up production from lab-scale to clinical and commercial scales to meet industry demand, they are likely to require volumes of hazardous materials that drive additional facility design considerations for code and regulatory compliance.

Read this article in BioPharm International’s November 2023 Manufacturing and Facilities eBook.

About the authors

Kyle Hubbard is process engineer at CRB; Bill Jarvis is senior fellow, Pharmaceutical Process, at CRB.

Article details

BioPharm International
eBook: Manufacturing and Facilities
November 2023
Pages: 14–21

Citation

When referring to this article, please cite it as Hubbard, K. and Jarvis, B. Oligonucleotide Production Facilities. BioPharm International’s Manufacturing and Facilities eBook. November 2023.