Preclinical Drug Delivery System Formulation Discovery and Optimization

Preclinical
Formulation Discovery and Optimization

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

Design and Optimization of Drug Delivery Systems

Designing, Functionalizing, Optimize, and Improvement on Lipid or Polymer Based Nanoparticles Nucleic Acids (mRNA, siRNA, DNA) and Olegonucleotides Antibody Peptides Proteins Small and Large Molecules
  • Designing, Functionalizing, Optimize, and Improvement on Lipid or Polymer Based Nanoparticles

  • Nucleic Acids (mRNA, siRNA, DNA) and Olegonucleotides

  • Antibody

  • Peptides

  • Proteins

  • Small and Large Molecules


Analytical Characterizations and Methods Development

Size by Dynamic Light Scattering Charge - Zeta Potential Purity by HPLC/ELSD, and UV UV-Vis spectroscopy Residual Solvent by GC-FID Identity Testing and Assays by HPLC-MS
  • Size by Dynamic Light Scattering

  • Charge - Zeta Potential

  • Purity by HPLC/ELSD, and UV

  • UV-Vis spectroscopy

  • Residual Solvent by GC-FID

  • Identity Testing and Assays by HPLC-MS


Sample Preparation for All Preclinical Studies

SAMPLE PREPARATION: Small to large scale sample preparation of LNP with or without your cargo, including LNP Nucleic Acids (mRNA, siRNA, DNA) Antibody Peptides Proteins Small and Large Molecules

Sample Preparation: Small to large scale sample preparation of LNP with or without your cargo, including

LNP

  • Nucleic Acids (mRNA, siRNA, DNA)
  • Antibody
  • Peptides
  • Proteins
  • Small and Large Molecules


Scalable Manufacturing Process Development

MANUFACTURING PROCESSES  We have all processes that are needed to prepare your LNP therapeutics or vaccine samples including: Solvent and Ethanol Injection Microfluidics Thin-Film Hydration Extrusion Microfluidizer Homogenization Lyophilization

We have all processes that are needed to prepare your LNP therapeutics or vaccine samples including:

  • Solvent and Ethanol Injection Microfluidics

  • Thin-Film Hydration

  • Extrusion

  • Microfluidizer Homogenization

  • Lyophilization


Studies Plan and Executions

STUDIES, EXPERIMENTATIONS, ANALYTICAL METHODS Our formulation department will help you plan, perform, and reporting such as: Stability Studies Size, Charge, UV-Vis, Purity and Concentrations (HPLC/GC-FID/GC-MS, and LC-MS)

STUDIES, EXPERIMENTATIONS, ANALYTICAL METHODS

 

  • Our formulation department will help you plan, perform, and reporting such as:

  • Stability Studies

  • Size,

  • Charge,

  • UV-Vis,

  • Purity and Concentrations (HPLC/GC-FID/GC-MS, and LC-MS)

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