Our services to the pharmaceutical industry include process development and manufacture of intermediates and API, from clinical trial quantities to large-scale volumes of up to hundreds of tons. We are your ideal scale-up partner, establishing cost-efficient, reliable, validated manufacturing processes. We provide additional regulatory support and expertise, full analytical services, stability Studies, and expert project management. We are committed to the highest quality standards, from ISO 9001 to full cGMP compliance. We are FDA and Swissmedic inspected. Click here for more reference projects.
Small molecule API for the US, European and Japanese Market
- Small molecule API for the US, European and Japanese Market: Carbohydrate and heterocyclic chemistry including high pressure catalytic hydrogenation (50) bar with the need to control several stereocenters.
- 11 step synthesis was transferred from lab scale to production
- Initial data was available only at a research level, the largest scale done before was 10 kg
- Production / validation on 1’000 kg scale in 11 months from scratch with no technical batch on production scale
Large-scale production of a non-regulated Pharma intermediate
- Three step process for an intermediate used in the production of an API blockbuster. RohnerChem accompanied the project from lab scale (2002) through piloting (2004) to large scale production
- Since 2006, Rohner has consistently delivered 100 MT per year of this non-regulated intermediate
- Optimization of critical process parameters (pressure, temperature) in combination with catalyst (catalyst screening important step) has led to superior quality
- Significant reduction of residual solvents (factor 10) and improvement of colour