Going large-scale with manufacturing of oligonucleotides

The growing number of oligonucleotide-based APIs is accompanied by an increasing need for efficient routes for their large-scale manufacturing. It is therefore essential to develop more efficient, more sustainable, and highly scalable manufacturing techniques. The speaker will give an overview of Bachem’s existing oligonucleotide capacity based on traditional packed bed synthesizers from small-, mid-, pilot- to large-scale and according chromatography. Besides scalability considerations and equipment comparisons, the talk will also outline currently ongoing capacity expansion, where a new, additional large-scale line for metric ton oligonucleotide output is commissioned.

Daniel Samson

Vice President, Head Oligonucleotides

Fragment-based approaches for acylated peptide synthesis; an analysis of cost and capacity

Acylated peptide are required in multi-tonne amounts for treating type-2 diabetes and obesity. This contribution will focus on cost and capacity models for fragment-based approaches and compare this with linear SPPS.

Leendert van den Bos

CEO of EnzyTag

Analytical Procedure Development for Novel Peptides: From Column Screening to GMP Releases

In the current pharmaceutical landscape, therapeutic peptides are on the rise. To ensure the large-scale production of peptides in the highest quality, Bachem implements a holistic analytical control strategy. Beginning with product-specific understanding of e.g. related impurities and aggregation behavior, state-of-the-art chromatographic detection methods are developed and validated. This approach alongside the process development enables that stringent product specifications in line with current regulatory demands are continuously met.

Priska Frei

Scientist QC