Rapid Scale-up of Lead Compounds
We meet aggressive timelines without sacrificing quality and regulatory compliance. Our track record demonstrates our ability to consistently deliver results under time constraints. We’re experienced and have successfully delivered FDA fast-track API approvals in near-record time.
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Contract Chemical Process Development and Route Optimization
Process development and route optimization represent a core part of our business. Ash Stevens has a dedicated staff of professional process chemists – they have the know-how to overcome process bottlenecks and make process improvements. Typical process enhancements include improvements in yields, throughput, scalability, safety, robustness, environmental impact and cost.
- Process development, route selection and optimization
- Process scale-up and validation
- Cleaning validation
- Safety/hazard assessment
- Comprehensive regulatory support
- Stability studies
- Method development and validation
- API manufacture and release
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Contract cGMP-API Manufacturing
Ash Stevens has a broad range of organic reaction experience. The newly constructed manufacturing facility in Riverview, Mich., includes pilot plant and commercial scale, glass-lined vessels with volumes ranging from 10 to 500 gallons and operating temperatures ranging from –80° to 200°C. Our capacity ranges from quantities as small as milligrams up to a metric ton.
Our isolation and purification technologies include extraction, filtration, centrifugation, barrier isolation systems (potent compounds), and distillation. The drying and finish equipment includes a variety of forced air and drying ovens, as well as class 10,000 (M5.5) clean suites.
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