All-Inclusive Platform of Formulation, Technology Transfer, and Manufacturing Preclinical to cGMP Commercial: Technologies and Services
Drug Delivery Systems (Lipids, Polymers, Hybrids)
We Form Variety of Partnership through Our Team and Technologies, and Perform Comprehensive and Collaborative Studies Including Practical Research: Development of Drug Delivery System with Desired APIs such as mRNA, DNA, siRNA, Antibodies, Proteins, Peptides and Other Small Molecules: Characterization, and Testing Services, Collaborative Company and Government Supported Developments (I.e. SBIR/STTR)
Analytical Testing, Characterization, Assay Development
Complete Analytical Custom Testing (GMP and Non-GMP) and Methods Developed for Early Stage Drug Developments, Analytical Testing, Developments and Technology Transfer, Full Panel Analytical and Assays Development Such as: Nanoparticle Size, Charge, Encapsulation Efficiency, Purity, Morphology, Residual Solvent, Transition Temperature, Visual Inspections, and Microscopic.
Preclinical Formulation Development and Samples
Feasibility and Comprehensive Studies, Nanoparticle Drug Delivery System Development (Preclinical Synthesis and Analytics), Including Ionizable and Cationic Lipid Nanoparticles as well as Polymeric and Hybrid Lipid Nanoparticles, Optimization, Characterization, Toxicity, Effectiveness, Analytical Methods, and Formulation Manufacturing Process, Small Scale Technology TransferPreclinical Formulation Synthesis, Optimization, Manufacturing Process, Drug Delivery Systems and Nanomedicines Development
Manufacturing Process Development (GMP)
T&T Scientific Offers Variety and In Fact all of Manufacturing Processes Used for Manufacturing of Nanoparticle Drug Products Such as Gene Therapies, and Vaccines. To Name.a Few These Processes Include: Ethanol Injection or Solvent Injection, Thin Film Hydration, Extrusion, Homogenization, Microfluidics and Sonication (Bath, Tip and Continuous).
Analytical Methods Development (Complete Panel, Characterization, Reporting)
At T&T Scientific, We Offer Complete and Full Panel of cGMP Analytical Panel Required for Quality Control of Nanoparticle Drug Products Such as: Nanoparticle Size, Charge, Encapsulation Efficiency, Purity, Morphology, Residual Solvent, Transition Temperature, Visual Inspections, Targeting and Endosomal Scape Properties and Microscopic. We Also Have Established Partners For Clinical Trials And Animal Studies.
cGMP Clinical and Commercial Batch Manufacturing, Fill and Finish
T&T Scientific Is Complete GMP Operation Under One Roof and Has been Audited Successfully Over 5 Times. T&T Scientific Corporation’s Quality Management System takes it guidance from 21 CFR Part 820 Quality System Regulations and complies all FDA GMP regulatory requirements. These requirements include 21 CFR Part 210, 21 CFR Part 211, and 21 CFR Part 11. The company claims no exclusions from the 21 CFR Part 820, 201, 211, 11 at 7140 Regal Lane, Knoxville, TN 37918.
Solvent Injection Manufacturing Technologies
Solvent Injection Technologies A Injection Of The Lipid Solution (In Ethanol Or Diethyl Ether) Into An Aqueous Medium Including Drug And Buffer. The Solvent Injection Methods Consist In The Lipid Dissolution Into An Organic Solvent And The Injection Of The Solution Into Aqueous Phase. Two Main Solvents (Ethanol And Ether)Have Been Employed For The Preparation Of Liposomal Nanoformulation. T&T Scientific Offers the World's Best Platform for Scalable, GMP, Controlled and Precise Production of Nanoparticle Drug Products in a Single Step.
Liposome Extrusion Manufacturing Technologies
Liposome Extrusion Techniques Are Used for Precisely Sizing Lipid Nanoparticles, Liposomes, Lipoplexes, Niosomes and Other Nano-scale Pharmaceutical Drug Products and Drug Delivery Systems. T&T Scientific Offers the World's First Single Use Lipid and Liposome Extrusion System that Allows Fast, Easy, Contamination-Free, and High Quality Production of These Nanomedicine Drug Products with PDI as low as 0.05-0.07
Drug Delivery Systems (Lipids, Polymer, Hybrids)
T&T Scientific Offers Both:
1) Ready-to-Use Products and Kits as Lipids , Polymers and Hybrid Nanoparticles
2) Under Development and Valuation Nanoparticles Made by Lipids (Cationic, Ionizable, and Neutral), Polymers, and Hybrid which Includes Different Types of Lipids and Polymers.
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