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cGMP Manufacturing

Overview

For over 40 years Avanti has provided API (Active Pharmaceutical Ingredient) Technology Development for Pharmaceutical and Biotechnology companies. Our unique reputation for quality in the development of pre-clinical and clinical candidates is well established. Our full range of services include process chemistry, scale-up manufacturing, supply chain management with analytical and regulatory requirements. Avanti’s experienced staff of chemists and lipid analysts are ready to meet your development needs with pre-clinical through phase III and commercial launch.

From Research & Discovery > Through Clinical Trials > To Commercialization

Facility

Avanti Polar Lipids, Inc. operates FDA inspected and approved facilities, which consist of a total of
80,000 sq/ft in five buildings on our campus, and include:

  • Synthetic Organic Laboratories
  • cGMP Analytical Laboratories
  • cGMP Kilo Laboratories
  • cGMP Chromatography
  • cGMP Stability Testing Services

Avanti’s facilities and range of services are well suited for lipids and hydrophobic small molecule API Technology Development from pre-clinical through phase III, and API commercial manufacturing for approved drug products.

The Avanti Focus

Avanti will establish a Development Team to ensure the smooth API development you need. Our experienced organic chemists will oversee the process development and scale-up while our lipid analysts guarantee that Avanti quality prevails at each step. A typical development path might include:

  • Synthetic process development
  • Synthetic scale-up developments (non-cGMP and cGMP)
  • Analytical development and validation
  • Full scale cGMP manufacturing with process validation
  • IND/NDA regulatory support and commercial launch

Products

  • Synthetic Phospholipids
  • Synthetic Sphingolipids
  • Cationic Lipids
  • PEG-Lipid Conjugates
  • Synthetic Neutral Lipids
  • Synthetic Cholesterol
  • Synthetic Adjuvants
  • Contract Manufacturing of Proprietary Lipid Compounds

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