Ash Stevens Facility

Facility

Ash Stevens’ corporate headquarters is located with its commercial drug substance development and cGMP manufacturing facility in Riverview, Michigan.

Ash Stevens Equipment & Operations

Equipment & Operations

State-Of-The-Art Equipment

  • Glass-lined batch reactors up to 4,000L
  • Plant-scale hydrogenation equipment
  • Centrifugal and Nutsche filtration equipment
  • Contained Rosenmund® filter dryers (glovebox technology)
  • Vacuum and convection tray drying ovens
  • Stability chambers (all ICH conditions)
  • Hazard analyses (RC-1) and API physical characterization equipment
  • High containment laboratories (airlocks) and equipment for development and cGMP manufacture of HPAPIs

Safety & Environmental Responsibility

The health and safety of our staff, visitors and community are the primary considerations in the operation of our business. Ash Stevens has an excellent chemical hygiene program in place that closely monitors air quality and other environmental data in our facilities to ensure a safe operating environment. Hazard identification and risk assessments are also an integral part of project management and planning.

EHS&S Programs

Ash Stevens' environmental health, safety and security (EHS&S) program is certified by the Society of Chemical Manufacturers & Associates (SOCMA) ChemStewards® program. ChemStewards® is SOCMA's flagship environmental EHS&S continuous performance improvement program and it ensures companies are compliant with all EHS&S regulations and best practices. Ash Stevens has received multiple awards from SOCMA for continuous improvement in this program.

Ash Stevens Process Development & Manufacturing

Process Development & Manufacturing

Riverview, Michigan

Ash Stevens' process development and drug manufacturing facility is where we conduct commercial activities. Our 60,000 sq. ft. facility houses eight chemical drug development and production laboratories, four full-scale production areas, and three analytical laboratories for quality control. Projects at this facility involve:

  • Process development
  • Material manufacture for toxicology studies
  • cGMP manufacture of clinical trial materials
  • High Potency API drug substance development and cGMP manufacturing
  • Post-approval commercial production of drug product
  • From grams to metric tons of API

Major Production Equipment Includes:

  • Glass-lined batch vessels (up to 4,000L), hydrogenation vessels and other pressure vessels
  • Centrifugal, Nutsche and contained filter-dryer equipment (with glovebox technology), and vacuum and convection tray drying ovens
  • Barrier isolation systems for manufacture of highly-potent or air-sensitive compounds

Major Quality-Control Instrumentation Includes:

  • High performance liquid chromatography (HPLC-equipped with the following detectors: VWD, DAD, CAD, RI and MS)
  • Gas chromatography (GC, GC with headspace, GC/MS)
  • High field NMR, UV/Vis and FTIR spectrophotometers
  • Total organic carbon analyzer and Karl Fischer titrators
  • Stability chambers maintained at ICH accelerated, intermediate, room temperature, refrigerator and freezer conditions
  • API solid state characterization and hazard analysis equipment

Ash Stevens Manufacturing Expansion

Manufacturing Expansion

Riverview, Michigan

In 2013, Ash Stevens completed a multi-million dollar expansion to its cGMP facility in Riverview, Michigan. The project was completed over several years and added large-scale production capacity to the site, including a commercial-scale reactor bay and a companion isolation bay.

The New Reactor Bay

The new reactor bay houses 2,000–4,000 liter glass-lined vessels with engineering controls for potent compound charging and handling. The adjacent isolation bay features a 1.5m2 fixed filter dryer with glove-box technology for contained isolation, drying and packaging of large-scale batches. This expansion gives Ash Stevens the capacity to meet the needs of most projects, while our company culture and expert personnel still ensure intimate client focus and comprehensive project management, which are fundamental to a successful outsourcing experience.

about ash stevens

Ash Stevens is a full-service pharmaceutical contract manufacturer (CMO) with over five decades of experience developing drug substances & manufacturing active pharmaceutical ingredients.

Ash Stevens Vision

To translate scientific discoveries into medicinal products that improve quality of life.