ANGELINI PHARMA SPA offer service "CDMO Services"
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Offer Service
Service Name
CDMO Services
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Specifications
- Service Category: Custom API development services (route scouting, continuous-flow process development, genotoxic/nitrosamine evaluation) and cGMP manufacturing.
- Regulatory Certification: cGMP manufacturing with process and analytical validation, plus ICH stability studies.
- Capacity Scale: Continuous-flow process development up to 10 kg/h, scaling to multi-ton continuous-flow manufacturing, with small- and large-scale HPAPI production (OEB5).
Other Information
Additional Description:
Custom development services include route scouting, process development, continuous-flow process development up to 10 kg/h, optimization and intensification studies, analytical method development, genotoxic evaluation, nitrosamine studies, crystallization and polymorphism studies, cGMP manufacturing, technology transfer, process and analytical validation, continuous-flow manufacturing at multi-ton scale, small- and large-scale HPAPI manufacturing (OEB5), kilo-scale through pilot and commercial supply, clinical supply, process safety assessments, and ICH stability studies.
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