HTD Biosystems Inc
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Formulation development/ Delivery systems

  • DNA
  • Proteins
  • Peptides
  • Nano-lipid particles (NLP)/ Liposomes
  • Vaccines

Freeze-drying

 Aseptic Preparation and GLP Fill/Finish of parenteral solutions for tox studies

IMG_2786.JPG
Aseptic preparation of liposomes for toxicological studies

Tech Transfer and Scale Up

  • Determination of critical formulation and process parameters 
  • Setting specifications      
  • Scale-up    
  • Tech Transfer to the GMP manufacturing site

Analytical Services 
  • Determination of tertiary protein structure (Second derivative spectrophotometry)
  • Protein content measurements (UV)

  • Osmolality measurements
  • Particle size characterization of proteins, liposomes and nano particles (Dynamic light scattering, DLS)
  • Solid-State Characterization (Differential Scanning Calorimetry, DSC)

Quality Management

  • Preparation of SOPs
  • Method development
  • Method qualificatio
  • High quality reports and documents for IND filing

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