Commercial Manufacturing with Full Analytical Panel Quality Assurance - Aseptic Fill and Finish
Formulation Discovery and Optimization
(Scale Up, Methods, Processes)
Commercial Batch Manufacturing, Fill and Finish
- Complete Commercial Drug Manufacturing Services from Start to Finish
- Experience reliability with best price guaranteed, on time delivery, always having additional team ready to help you with quickest turn around and highest quality standards from T&T Commercial CDMO.
- Our focus is always exceeding expectations by being under budget, on time, and high quality. Our team has technology transfer extensive experience team who initiated and executed over 20 lipid nanoparticle pharmaceutical drugs projects
- We guarantee to cut cost with our automated minimized human error platforms, call us to learn how you can significantly improve your margins moving from traditional CDMO to fully integrated technology service company.
- Technology transfer from start to finish
- All pharmaceutical liquid lipid nanoparticles including
- LNP mRNA and All polymer and hybrid lipid nanoparticles
- LNP siRNA and all polymer and hybrid lipid nanoparticles
- LNP DNA and all polymer and hybrid lipid nanoparticles
- LNP Conjugated Targeting Antibodies
- Any other API lipid and polymer nanoparticle
- Single-use and cleanable cGMP technologies for 1000L+ batches as fast as one week release
- 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 for pegylated pharmaceutical complexing
- 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
- 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 products
Quality Assurance with Complete Analytical Panel
- At T&T Scientific, the patients who taking these novel pharmaceutics, and the clients who we work with are above any other priority for us. We will be part of your team with weekly updates and report on detail progresses, that exceed any expectation, and make us unique and competitive with traditional CDMOs.
- Our strict quality team with expectation of excellence will make sure your products are manufactured to your exact expected specifications.
- We have a team for quality assurance of your products to cover the full analytical panel assays
- T&T Scientific has clinical client in from all around the world including Asia, Europe and United States.
Commercial Drug Manufacturing Services
- 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