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CMC Development

Tag-Assisted Peptide Synthesis (TAPS)

White Papers and Case Studies

IMPROVING OLIGO MANUFACTURE WITH STIRRED-BED

Oligonucleotide-based active pharmaceutical ingredients (APIs) have emerged as a powerful approach to treating diseases. With hundreds of them in advanced clinical trials, a potential metric ton demand for certain products is expected that might not be easily fulfilled by conventional solid phase oligonucleotide synthesis (SPOS). It is essential to develop more efficient, more sustainable, and highly scalable manufacturing techniques.
This whitepaper explains how the innovative stirred-bed technology (SBT) for SPOS fulfills all these requirements and represents an economical engineering solution with a simple reactor design and adapted chemistry. Thus, ton-scale commercial oligonucleotide API manufacture with unmatched process mass intensity is within reach.

Continuous Chromatography – Pushing the boundaries of peptide and oligonucleotide production

During the manufacturing of a peptide API, well-established purification is crucial for achieving high purity and yield, and at the same time is a major determinant for the cost efficiency and process productivity.

Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) has shown to achieve substantially higher capacity and yield than single-column batch processes. This innovative purification process leads to time savings, economic advantages and a lower environmental footprint.

Greener purification at large-scale

An oligonucleotide case study

Resembling a new era of innovative drug development, the interest of the biopharma industry in the oligonucleotide markets has grown significantly in the past five years.

In 2021, the US Food and Drug Administration (FDA) approved the first-in-class siRNA to lower cholesterol – a drug with a multi-ton potential to treat millions of patients per year. Moving forward, the demand for oligonucleotide batch size is likely to increase as well as the need for large-scale manufacturing capacity to support this growth.

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