Development

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Pharmaceutical Development Services

GRAM provides a wide variety of development services to support parenteral formulations.

Formulation

GRAM’s formulation development capabilities can be applied to large and small molecule, antibody (modified), DNA (plasmid), manipulated/transplanted cells, biologic proteins, enzymes, biologic and chemical peptides, antibodies, protein conjugates, inactive vaccines, monoclonal antibodies, and recombinant proteins.

Process

The GRAM  team can address all aspects of process development for small- and large-molecule parenteral dosage forms, including solutions, suspensions, and lyophilized products.

  • Formulation Development
  • Analytical Method Development and Validation
  • QbD Implementation
  • Manufacturing Process Design, Optimization, and Scale-up
  • Sterilization Cycle Development
  • Lyophilization Development
  • Technical Transfer
  • Labeling and Packaging Design
  • Stability Storage and Testing
  • Regulatory Affairs Support
  • Project Management

Analytical Services

Our analytical development, validation and analytical testing services include:

  • Drug Substance and Reference Standard Material Characterization
  • Reference Standard Qualification
  • Cleaning Method Verification/Validation
  • HPLC (High Performance Liquid Chromatography)
  • Wet Chemistry Testing
  • Container Closure Integrity
  • Particulate Matter Injection (<USP 788>)
  • Endotoxin (<USP 85>)
  • Bioburden
  • TLC (Thin Layer Chromatography)
  • GC (Gas Chromatography)