clinical and commercial manufacturing

Clinical and Commercial Manufacturing

Serving pharmaceutical and biotechnology industries at T&T Scientific Contract Development and Manufacturing Organizations (CDMO), we offer and support comprehensive and complete GMP services required for the development, clinical and commercial manufacturing of pharmaceutical nanomedicines from start to finish:

  • Sterile Manufacturing of pharmaceutical Injectables
  • Small Batches:  uL's to mL's Batch Sizes (i.e., Personalized Medicine) 
  • Medium Scale: 10mL-20L (i.e. Clinical Phase I/II/III Gene Therapies)  
  • Large Scale: 20-1000L+ (Phase III and Commercial Manufacturing
  • Covered Formulations Compounds: PEGylated, Nucleic Acids (mRNA, siRNA, DNA, saRNA), Proteins, Lipids,  
  • Stability Programs throughout the Commercialization
  • Full Assay Analytical Methods and Quality Control Testing  
  • Project Management and Weekly Meetings
  • Quality Assurance, Risk Management and Compliance
  • Sterile Filtrations 
  • Sterile Fill, Finish, and Labeling 
  • Supply Chain and Raw Material Management 
  • Container-closure Integrity

Batch Sizes

  • Small Batches: uL's to mL's Batch Sizes (i.e., Personalized Medicine) in mL 
  • Medium Scale: 10mL-20L (i.e. Clinical Phase I/II/III Gene Therapies)  
  • Large Scale: 20-1000L+ (Phase III and Commercial Manufacturing)

Formulation Focus

  • Lipid Nanoparticle (LNP) Drugs
  • Polymeric Nanoparticle (PNP) Drugs 
  • Polymeric+Lipids (Hybrid Nanoparticles)
  • Nucleic Acids: mRNA, siRNA, DNA, saRNA, tRNA  and rRNA
  • PEGylated Formulations (Liposomal, Lipid-Based, Polymeric, and Hybrids

Manufacturing Processes

  • Solvent Injection
  • Microfluidics Mixing
  • Tangential Flow Filtrations (TFF)
  • Thin Film Hydration (TFH)
  • Extrusion
  • Homogenization
  • Sonication (Tip, Bath, Continuous)

ANALYTICAL ASSAYS

Morphology of the liposomes, including, lamellarity determinationSurface characteristics of the liposomes, as applicable, e.g., pegylation. 
Particle SizeViscosity
Net charge, and Zeta PotentialsDrug Concentration and Purity 
Residual Solvent Content  Transition Temperature 
Quantification of In Vitro Release of the Drug Substance Leakage Rate of Drug Ingredients (API) from the Liposomes and Lipid Nanoparticles Throughout Shelf Life
Leakage Rate of Drug Ingredients (API) from the Liposomes and Lipid Nanoparticles Throughout Shelf LifeEncapsulation Efficiency Assays for APIs such as Plasmid DNA, mRNA, siRNA, Antibodies, and etc. 

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