Chemistry, Manufacturing + 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

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.

Topics: Chemistry, Manufacturing + Controls (CMC) Discovery ADMET and In Vitro Metabolism Disease Focus Areas Drug Discovery Drug Formulation Development Infectious Diseases Pharmaceutical R+D
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.

Topics: Chemistry, Manufacturing + Controls (CMC) Clinical Laboratory Services Disease Focus Areas Drug Discovery

Press Releases

Jia-Hwa Fang
Jia-Hwa Fang Joins SRI Biosciences as Director of Clinical Manufacturing

Jia-Hwa Fang, Ph.D., has joined SRI Biosciences as Director of Clinical Manufacturing. In this new role, he will lead a team to transfer and scale-up R&D, Good Laboratory Practice (GLP), and pilot formulations for early stage clinical trial materials.

Topics: Chemistry, Manufacturing + Controls (CMC) Clinical Laboratory Services Combinatorial Chemistry Drug Discovery Drug Formulation Development Drug Pipeline Pharmaceutical R+D Pharmaceutical Sciences: Analytical Chemistry Pharmaceutical Sciences: Stability Studies Pre-formulation Studies
SRI International Awarded National Institutes of Health Preclinical Services Contract

SRI International announced that it has been awarded a $20 million preclinical services contract by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Topics: Basic Cancer Research Chemistry, Manufacturing + Controls (CMC) Developmental + Reproductive Toxicology Discovery ADMET and In Vitro Metabolism Disease Focus Areas Drug Formulation Development Genetic Toxicology Immunology + Inflammation Medical Imaging Medicinal Chemistry Pharmaceutical R+D Pre-formulation Studies Preclinical Development Plans + Regulatory Services Proteomics

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