White Paper

Considerations And Strategies For Oligonucleotide Manufacturing Scale-Up

By George Flores, Technical Solutions Manager, Asahi Kasei Bioprocess

DNA Strand

Oligonucleotide therapeutics are revolutionizing the way scientists target molecules that are beyond the reach of conventional drugs. As the field of oligonucleotide development continues to expand and mature, manufacturers scaling their processes are entering uncharted territory, given that most oligonucleotide development has so far occurred in labs. While this is a necessary leap forward, scale-up does bring with it significant challenges, which we will outline here. We will also look at potential solutions and considerations during key process steps that play key roles in the overall success of scale up.

In this white paper, you will find:

  • In-depth overviews of the upstream and downstream oligonucleotide manufacturing processes
  • Facilities and equipment considerations to help you achieve sustainable chemistry practices
  • Workforce challenges and how automation helps to fill the skills gap created by a tight labor market
  • Detailed breakdowns of the unique challenges that arise during scale-up
  • Guidance on scale-up to maintain the target product quality attributes and yield
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