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Bachem drives innovation and invests into new oligo manufacturing capacities to meet the needs of our customers.
Released By Bachem
November 17, 2022
The therapeutic usage of oligonucleotide-based drugs is growing. Moving from rare diseases to chronic indications, the market demand for oligonucleotide therapeutics keeps increasing and is coupled by the emergence of new challenges related to scalability, sustainability and cost. Recognizing this, Bachem drives innovation and invests into new oligo manufacturing capacities to meet the needs of our customers. We built facilities and implemented new, innovative solutions for large-scale oligonucleotide based Active Pharmaceutical Ingredients (API) production. With our GMP-qualified equipment, we are already developing and manufacturing oligonucleotide-based API together with our customers. These new chemistry and manufacturing capabilities are complemented by the support of exceptional analytical chemistry teams. We have a long-standing expertise in developing and validating test methods for large and structurally complicated molecules. To support our customers in their oligonucleotide development, we offer a full range of Chemistry, Manufacturing and Control (CMC) services starting with the establishment of scalable manufacturing processes and ending with Investigational New Drug (IND) application and New Drug Application (NDA). Innovations that solve industry challenges on API development As a new therapeutic modality, oligonucleotides present numbers of challenges on regulatory aspects for the agencies and the pharmaceutical companies. So far, no guidelines from the International Council for Harmonization (ICH) nor from the U.S. Food and Drug Administration (FDA) have been published for the specifications of oligonucleotides quality expectations. No consensus has been found to report thresholds for impurities identification and qualification. Indeed, the nature of oligonucleotides makes them complex to characterize, as well as the impurities that can arise from their production. Most impurities exist as mixtures of closely related molecules of the target API and become tedious to separate during chromatography purification. Furthermore, there is a lack of analytical methods to accurately resolve these impurities. Therefore, having expertise in peptides is a big advantage because of the many similarities between oligonucleotides and peptides. Our world-class TIDES team is used to building in-depth know-how based on past experiences in the production of commercial API. At Bachem, we are aware of these challenges and anticipate an evolution of the quality expectations and standards. Based on this observation, we have technologies in place to deliver improved impurity profiles accompanied with the required analytics: Continuous chromatography for a resolved separation of product and close impurities Maximizing yield and quality in a sustainable, streamlined way has always been important for API production. Continuous processes are the perfect method to tackle these challenges in large-scale manufacturing. We have set up the first continuous chromatography system, a MCSGP (Multicolumn Countercurrent Solvent Gradient Purification) technology, for center-cut purification at industrial scale. The innovative MCSGP technology represents great progress in the downstream processing for peptides and oligonucleotides. The process allows a higher capacity at typically 30% lower solvent consumption, and reaches the target purity of the product often with a higher yield, typically 10 % more, compared to a conventional single-column batch purification. It is a scalable, highly efficient and cost-effective process – particularly for large scale production. It is also an automated system, which can run 24/7, allowing a significant decrease in the purification campaign cycle times. An additional benefit is that MCSGP is a more sustainable process. It reduces solvent consumption and process mass intensity (PMI). Finally, MCSGP deploys standard chromatographic conditions, and API quality is not adversely affected by changing from batch to continuous mode. This technology increases capacity, quality and sustainability of the purification process (Figure 1).
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