By Bachem AG
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Bachem expands large-scale oligonucleotide manufacturing capabilities
Bubendorf, Switzerland: –Peptide technology specialist Bachem is meeting the rapidly increasing global demand for small molecule oligomer therapeutics by implementing new, innovative solutions for large-scale oligonucleotide API production.
Interest in oligos has grown, as has the market demand, since their emergence as a new drug modality at the start of the millennium. Initially focusing on rare diseases, oligonucleotide therapeutics are now moving into more common chronic indications like asthma, diabetes, chronic renal failure, as well as cardiovascular and liver diseases.
Unprecedented oligo demand
This has led to unprecedented need for large-scale manufacturing to support market requirements for oligonucleotides, coupled with the emergence of new challenges related to scalability, sustainability and cost.
Recognizing this, Bachem saw the opportunity to expand its existing manufacturing capacity and introduce innovative solutions for large-scale active pharmaceutical ingredients (APIs). It has recently built new cGMP qualified production facilities and is already working on development of customers’ oligonucleotide-based APIs.
Bachem constantly innovates to improve its processes for higher product quality, larger scale, more cost-efficiencies and sustainability. It has now implemented unique engineering solutions in every piece of equipment for each step of the oligonucleotide manufacturing process.
This includes setting up a large-scale synthesizer for oligonucleotides, customized with specific solutions to improve process control and crude API purity. For the cleavage and deprotection (C&D) step, Bachem has designed a unique large-scale automated C&D system giving enhanced production safety and efficiency.
For oligonucleotide purification, Bachem has successfully harnessed synergies in technology and know-how from its strong peptide chromatography expertise, in which it pioneered continuous chromatography on an industrial scale. This has enabled Bachem to build large-scale equipment for oligonucleotide purification, delivering significant advantages in capacity, cost and sustainability by improving yields and purity of products as well as reducing solvent consumption and process mass intensity.
Bachem is also innovating the isolation step to ensure a streamlined process with the highest quality of oligonucleotides. For instance, lyophilization is one of Bachem’s core expertise at high capacity with clean rooms available to avoid any bottlenecks.
Bachem’s world-leading expertise in peptides makes it ideally placed to act as a trusted partner in oligonucleotide development and manufacturing, with in-depth expertise on every aspect of oligonucleotide production processes, and the ability to identify where it can improve and leverage its oligonucleotide manufacturing capabilities.
Bachem’s mission is to simplify the lives of customers seeking to develop and commercialize oligo-based APIs, with a suite of services that meet every need. These include:
- Large-scale GMP manufacturing capacity available from preclinical to commercial scale
- Full range of Chemistry, Manufacturing, and Control (CMC) development services
- Full package of in-house analytical capabilities
- Regulatory support for IND and NDA applications
- Experienced and dedicated Project Management.
Outsourcing API development and manufacturing to Bachem allows its customers to gain flexibility, efficiency and speed of market entry, also minimizing risks during the drug’s development and commercialization phases.
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides.
With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services.
Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.
For further information, see www.bachem.com.
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