Olon’s Daptomycin celebrates its 10th anniversary, and in the very year that marks the first decade of production of this first in a new class of antibiotics that represented a breakthrough in the treatment of skin infections, the leading API supplier Group announces the doubling of its production to meet and exceed global demand for the active ingredient. Olon manufactures Daptomycin by biomanufacturing — in its Biotech centers that are fully integrated with the company’s global manufacturing network — through an advanced and highly complex process of fermentation and purification, thanks to which it has maintained a high level of competitiveness and product sustainability on a global scale over the past 10 years.
The story of Olon Daptomycin began in 2014, with the validation of the first batch. The launch was preceded by massive investment in research and development to achieve a high level of knowledge of the product and its production process, which led to its improvement in terms of sustainability, guaranteeing a very high-quality final product. In the following years, Olon launched in the US and Europe, in parallel with a gradual and steady increase in its market offering. By investing in facilities, it significantly increased its capacity following the growth trend of the global market. The additional expansion milestone announced today will allow the current production capacity to be doubled by 2025 to cover a large proportion of world demand.
Olon was the first API supplier to launch generic Daptomycin in the world, and the first to enter the US and EU markets, with significant production volumes from the offset.
“Ten years on, thanks to continuous improvement, we continue to remain very competitive in all markets without ever losing our focus on the sustainability of the production process,” explains Giorgio Bertolini, VP R&D at Olon. “This is thanks to two keys to success: the first key is the development of a complex research and development strategy integrated with the regulatory strategy, aimed at both achieving a robust process ensuring a product with high quality standards and fully complying with the regulatory requirements for the highly complex peptide that is Daptomycin. The second key to success was a very thorough feasibility study that led to the recovery of the vast quantities of solvents used in the process with the absolute guarantee of zero impact on the quality of the final product. This enables us to be highly sustainable by reducing resource use, process-related environmental impact and ultimately production costs. The impact of all the continuous improvements in our processes used for all our APIs, including Daptomycin, means that we can guarantee access to essential therapies for the health of patients worldwide, at a sustainable price and of high quality.”
Daptomycin was the first member of a new class antibiotics, the cyclic lipopeptides, with a broad spectrum covering Gram-positive pathogens, including multidrug-resistant organisms.
HISTORY
2014 – Validation of the Olon daptomycin process
2017 – Launch of Olon daptomycin in the US market, first API supplier to launch generic Daptomycin
2018 – Launch of Olon daptomycin in Europe, first API supplier to launch generic Daptomycin
2024 – Olon makes investments towards significant expansion, reaching double its production capacity
PRODUCTION OF DAPTOMYCIN BY BIOMANUFACTURING
Strain improvement by mutagenesis and genome shuffling
- Mutagenesis and genome shuffling experiments
- Strain selection by high-throughput screening methods
- Micro fermentation experiments
Strain selection
- Fermentation experiments
- Set up of analytical methods
Fermentation process development
- Fermentation process study
- Definition of optimised parameter for the feed strategy
- Definition of optimised media composition
DSP process development
Process qualification
- Sameness with RLD demonstrated through extensive characterisation studies
Biomanufacturing products means reducing
- CO2 or other emissions
- Waste
- Complex starting materials
