All-inclusive Platform of Services and Technologies with Proven and
Deeply RootedExpertise on Nanoparticle-Based
Drug Products (LNPs, PNPs, and Hybrids)from
Preclinical Formulations to cGMP Manufacturing
T&T Scientific’s Electronic Quality Management System (eQMS)
Guided bythe FDA 21 CFR Part 820 Regulations and Complied with
All FDA 21 CFR Part 210, 21 CFR Part 211, and 21 CFR Part 11 Regulations
Fully Integrated and Automated Nanoparticle Pharmaceutical Manufacturing Technology Platform:Scalable & Continuous, Implementing Machine Learning and Artificial
Intelligence inPharmaceutical Manufacturing:
mLs to 100s of L's | Low Cost | High Throughput | Small Foot-Print NanoSizer FLOWTM Technologies

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.
All Inclusive Platform Technology and Service Contract Development and Manufacturing Organization (CDMO)
All Inclusive Platform Technology and Service Contract Development and Manufacturing Organization (CDMO)
Compliant with FDA 21 CFR Part 820 Regulations, FDA 21 CFR Part 210, 21 CFR Part 211, and 21 CFR Part 11 Regulations
Fully Integrated Nanoparticle Drug Products Manufacturing Technology Platform
:Scalable & Continuous:
mLs to 100s of L's Batch Sizes

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

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

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
T&T Scientific Is an All-inclusive Platform of Services and Technologies with the Focus on Biopharmaceutical Nanoparticle-Based Drug Products Formulations and Manufacturing
Our Scalable, High-Quality, and Low-Cost Manufacturing Platform Produces Precise, High-Throughput, and Quality-ControlledTherapeutic Nanomedicines and Vaccines
Our Services Include Formulation, Developing, and cGMP Manufacturing of Nanomedicines and Gene Therapies from Preclinical to Commercial Stageswith Various APIs Scaling from Microliters to more than 100 Liter Batches.
T&T Scientific Has Established Clients and Partnerships in over 50 Countries,with a Customer-Centric and Educational Talent Development Culture to Effectively Create the Forthcoming All-Inclusive Personalized and Translational Medicine Platform.

Lipid-Based Delivery Systems in Development of Genetic and Subunit Vaccines
Lipidic carriers are composed of natural, synthetic, or physiological lipid/phospholipid materials.

Optimization of storage conditions for lipid nanoparticle-formulated self-replicating RNA vaccines
One of the first experiments on the delivery of RNA molecules dates back to 1978, when mouse lymphocytes were transfected in vitro with mRNA encoding rabbit globin using liposomes

Scope and challenges of nanoparticle-based mRNA delivery in cancer treatment
mRNA has a unique and transient expression that lowers the risk of insertional mutagenesis. Since the discovery of in vitro transcribed mRNA, synthetic mRNA has gained tremendous interest from different biology, medicine, and material science scientists.

Taylor Dispersion Analysis to support lipid-nanoparticle formulations for mRNA vaccines
Lipid nanoparticles (LNPs) are currently the most advanced non-viral clinically approved messenger ribonucleic acid (mRNA) delivery systems....

Payload distribution and capacity of mRNA lipid nanoparticles
Lipid nanoparticles (LNPs) are effective vehicles to deliver mRNA vaccines and therapeutics. It has been challenging to assess mRNA packaging characteristics.....

Circular RNA: An emerging frontier in RNA therapeutic targets, RNA therapeutics, and mRNA vaccines
Circular RNAs (circRNA) is a class of natural (biogenic) or synthetic closed RNA without 5′ or 3′ ends......

Full encapsulation of oncolytic virus using hybrid erythroctye-liposome membranes for augmented anti-refractory tumor effectiveness
Lipid nanoparticles (LNPs) are currently the most advanced non-viral clinically approved messenger ribonucleic acid (mRNA) delivery systems.

Lipid Nanoparticles─From Liposomes to mRNA Vaccine Delivery, a Landscape of Research Diversity and Advancement
Impact of anti-PEG antibodies induced by SARS-CoV-2 mRNA vaccines

Why mRNA-ionizable LNPs formulations are so short-lived: causes and way-out
Over time, a trace amount of ethanol degrades the lipid membrane, making the formulation unstable.

Albert Einstein
Physicist
"Imagination is more important than knowledge. Knowledge is limited. Imagination encircles the world.... The important thing is to not stop questioning. Curiosity has its own reason for existing.... Life is like riding a bicycle. To keep your balance, you must keep moving.... Strive not to be a success, but rather to be of value....."

Thomas Edison
Inventor
"Never get discouraged if you fail. Learn from it. Keep trying.... I have not failed. I've just found 10,000 ways that won't work.... Restlessness is discontent and discontent is the first necessity of progress. Show me a thoroughly satisfied man and I will show you a failure."

Bob Langer
MIT - Harvard
"Encourage students to work on high impact projects that can change the world. Never say this idea can’t work. Just follow your heart. Pick something you think you are going to love. I was trying to develop a controlled release polymer and things weren't working well. There were hundreds of possible ways to think about doing this... My intuition helped lead me to a way that worked."

Steve Jobs
Apple
"People think focus means saying yes to the thing you've got to focus on.... It means saying no to the hundred other good ideas that there are. You have to pick carefully. Don't let the noise of others' opinions drown out your own inner voice... Sometimes life hits you in the head with a brick. Don't lose faith..... It's not a faith in technology. It's faith in people.

Jack Ma
Alibaba Group
"If you don't give up, you still have a chance. Giving up is the greatest failure. I have failed funny things: key primary school test for two times, three times in middle school, I applied for Harvard, for 10 times, rejected; I applied for KFC when it arrived in China. 24 people came for the job, 23 got it. I was the only one who didn't.”

Jeff Bezos
Amazon
"If we can keep our competitors focused on us while we stay focused on the customer, ultimately we'll turn out all right.... What's dangerous is not to evolve. Amazon is the best place in the world to fail... the best place in the world to fail and failure and invention are inseparable twins. Companies that don't continue to experiment or embrace failure eventually get in the position where the only thing they can do is make a Hail Mary bet at the end of their corporate existence."