Phase I/II/III Clinical Development and Manufacturing

Preclinical
Formulation Discovery and Optimization
Preclinical Development
(Scale Up, Methods, Processes)
Clinical Phase I/II
Commercial
Fill and Finish

Phase I, II, III Clinical Batch Manufacturing

Phase I

Phase II

Phase III

  • Single-use cGMP Batch Manufacturing: 500 L, 1000 L, and 2000 L
  • Multiple single-use platforms supported
  • Manufacturing Platforms:
  • Ethanol Injection Techs (From 1mL Batch to 1000+ Liter Batch)
  • Extrusion Technologies (From 1mL Batch to 100 L Liter Batch)
  • Microfluidics Microfluidizer Homogenization (From 1mL Batch to 1000+ Liter Batch)
  • Thin film hydration
  • Wide range of mixing technologies and pumps
  • Lyophilization Small to Large Batches up to 10kg
  • Sonications and Nano and Micro Emulsions
  • Guaranteed fastest delivery on time and under budget
  • Flexible bio-manufacturing solutions
  • Technology transfer with extensive experience team who initiated and executed over 20 lipid nanoparticle pharmaceutical drugs
  • Expandable and scalable manufacturing space to be expanded up to 82,000 sq.ft.
  • Supporting Scale Up Flexibly with a Novel Strategy for most smooth delivery of project with most speed, lowest price, and highest minimized human error free products

Complete Analytical Panel and Methods Development for Quality Assurance

We have a team for quality assurance of your products to cover the full analytical panel assays

  • Surface Charge, Zeta Potential Method Development - Compliant with USP Standards and FDA requirement
  • UV-Vis for light absorption characterizations - Compliant with USP Standards and FDA requirement
  • Osmolality Compliant with USP Standards and FDA requirement
  • Viscosity - Compliant with USP Standards and FDA requirement
  • Concentration Methods Using High-Performance Liquid Chromatography (HPLC) with UV-Vis, Evaporative Light Scattering Detector (ELSD) and Refractive Index, Fluorescence Detectors Compliant with USP Standards
  • pH Assay Using Compliant with USP Standards
  • Visual Appearance Compliant with USP Standards
  • Residual Solvent Using Gas Chromatography Flame-Ionization Detection (GC-FID) and Headspace Samplers - Compliant with USP Standards and FDA requirement
  • Content Purity Using High-Performance Liquid Chromatography (HPLC) with UV-Vis and Refractive Index, Fluorescence Detectors - Compliant with USP Standards and FDA requirement
  • Thin Layer Chromatography -Compliant with USP Standards
  • Mass Spectroscopy: we use HPLC-MS for measurement of the specific molecule
  • Complete ICH Short and Long Term Stability Studies

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