Chemistry, Manufacturing and Controls (CMC) | SRI International

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Chemistry, Manufacturing and Controls (CMC)

SRI’s dosage form manufacturing facilities are designed to provide you with a single, high-quality resource for the manufacture and packaging of oral, topical, and parenteral products for nonclinical and clinical studies. These activities are supported by our Quality Control and Quality Assurance Units which inspect, test, and release the products in full compliance with the FDA GLP and cGMP regulations and international regulatory agencies.

Our R&D, GLP, and cGMP facilities and equipment are designed to support early phase development. The low volume batches needed for safety evaluations and early clinical trials present unique challenges, and we are ready to work with you to overcome limited bulk drug supplies and tight turnaround times.

Our extensive collection of manufacturing equipment provides the capabilities needed to produce R&D, pilot, and clinical-scale batch sizes, including:

Mixing and Blending

  • Planetary mixers
  • V-Blenders
  • Emulsifiers

Solid Dosage Forms

  • Capsule filling, sizes 00 to 4 and DB
  • Capsule bander
  • Capsule polisher
  • Capsule sorter
  • Tablet press
  • Extruder

Milling

  • Low-speed mills
  • High-speed mills

Granulation

  • Roller compactor
  • Granulator/oscillator
  • Spheronization

Coating

  • Pan coater
  • Spray coater

Packaging

  • Liquid and semisolid fillers
  • Blister pack sealer
  • Heat sealer
  • Laminated tube sealer
  • Vial capper

Sterilization

  • Autoclave
  • Depyrogenation
  • Sterile filtration

 

Projects

Innovative Science Overcomes Formulation Challenges

Innovative Science Overcomes Formulation Challenges

Partnering to Advance Therapy for Radiation Exposure

Partnering to Advance Therapy for Radiation Exposure

gloved hand catching pill capsules coming out of a dispenser

SMARTT Projects: Treatments for Lung, Heart, Blood Diseases

Through a broad range of services for the National Institutes of Health, SRI is accelerating preclinical development of potential therapies for diseases that affect millions of people.

bioscience workers in a lab

Anti-Infectives Development for National Institutes of Health

SRI is conducting preclinical development of treatments for diseases such as tuberculosis, West Nile virus, hepatitis, and biodefense pathogens and toxins.