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Disruptive purification consumables for the pharmaceutical industry

Periodic Reporting for period 1 - Separative (Disruptive purification consumables for the pharmaceutical industry)

Reporting period: 2018-03-01 to 2018-07-31

SEPARATIVE is a French startup developing consumables for purification by chromatography thanks to a ground-breaking multicapillary material and the related manufacturing process, both protected by four patents. It is the first innovation for several decades that disrupts the state-of-the-art high-pressure constraints of the High-Performance Liquid Chromatography (HPLC), and that achieves chromatographic purification and analysis without the inherent high-pressure and high-cost. SEPARATIVE allows to offer reusable low-pressure HPLC columns and reduces the cost of current chromatography by a factor of 10-50 (depending on the application).
The technology was validated by an independent laboratory. The manufacturing process internally developed and assessed, including an industrial pilot plant, demonstrated some strong productivity and cost-effectiveness potential. On this basis, the industrialization was the next step to ensure the reproducibility of the manufacturing, reach the market performances expectations, and make the process scalable.
The SME Phase 1 involved an industrialization study including an automation study, a value chain organization analysis and a marketing mix review.
The outcomes of the work plan include the technical solutions and the roadmap toward the process automation, a better knowledge of the supplier landscape and the identification of the partners needed, and a comprehensive marketing mix definition that give SEPARATIVE’s team strong confidence in the way to carry out the future beta testing program.
The progresses achieved are critical for the following of the project. They include some decisive development as much from the business point of view as the production end :
- a more accurate knowledge of the market expectations,
- the automation of the key steps of the manufacturing process,
- the definition of the control process,
- the design of the next version of the pilot plan,
- the selection of the key suppliers.
The expected results are the industrialization validation and the gathering of the expected conditions to initiate an optimization program of the product to improve its performances.
Bringing the product to the market will provide several technological advantages to the healthcare industry: better quality of drugs due to higher purity, lower investments for production plants (savings of 59% for separation), lower manufacturing costs due to better yields (no losses of valuable material in process) and higher security of manufacturing process due to lower volumes of flammable and toxic solvents.
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