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Discovery, Design, Formulation Optimization

Preclinical vaccines, and therapeutic formulation discovery, design, and developments: Lipid Nanoparticle formulation design, optimizations, with full analytical support. Whether you work with RNAs (i.e. mRNA, siRNA), DNA, Peptides, Antibodies, and other small or large molecules, our team at formulation is equipped with required facility, expertise, focused experienced. Lets get started:

Please only fill out related sections to your project. No need to complete every field, our team is ready to help direct your project at any state. If NDA is required and not executed, you can only submit as much as not confidential. We will help you place in an NDA however is preferred by you and your organization.

What stage of formulation discovery your therapeutic or vaccine is? (i.e. API Ready?)

Do you have delivery system for your drug developed?

Do you have the API and LNP design and optimization completed?

Full Name

Value is required

Title

Value is required

Organization Name

Value is required

Organization Address

Value is required

Organization Website

Do you require Confidential Non-Disclosure Agreement?

This field is required

Company Tax ID/VAT

Have you already signed Confidential Non-Disclosure Agreement with T&T Scientific?

This field is required

Click here to download our mutual Non-confidential agreement

Key Parameters

Drug Substance

Lipid Components: Biological/Synthet

Non-Lipid Components

Inactive Ingredient and Buffer

Amount For liquid – mg/ml and mg/vial

Morphology of LNP or Liposomes, etc.

Viscosity

Nanoparticle Size

Transition Temperature of Lipid and API

In Vitro Release of the Drug

Leakage Rate of Drug Shelf Life

Drug Release Amount

Drug Encapsulation Efficiency

Drug Loading

Salt Concentration

Analytical Methods

What Analytical Methods Are You Intending to Complete?

Size

Net Charge - Zeta Potential

Morphology and Lamellarity

Drug Encapsulation Efficiency

Pegylated Contents

Phase Transition Temperature.

In Vitro Release of the Drug Substance from the LNP/Liposome

Leakage Rate of Drug from LNP/Liposomes

Drug Release

Liposome Drug Loading

Manufacturing Processes

What Analytical Methods Are You Intending to Complete?

Microfluidics Solvent or Ethanol Injection

Thin-Film Hydration

Extrusion

Lyophilization and Freeze Drying

High Pressure Homogenization

Sonication

Freeze-thawed

Micro- or Nano- Emulsification

Lyophilization and Freeze Drying

Dried Reconstituted Vesicles

T&T Will Develop for Your Drug

Morphology

What Is the Morphology of Your Nanoparticles?

Lipid Nanoparticle

Liposome

Micelle

Lipoplex

Cationic Lipid Nanoparticle

Ionizable Lipid Nanoparticle

Cationic Nanoemulsions

Pegylated Lipid Nanoparticle

Lipopolyplex

Safety

Do you have Safety Data Sheets?

Have You Validated ICH Viral Vlearance?

Any OSHA Consideration?

Any DEA or EPA Consideration?

Product

Select all that applies to your project

Analytical Method Development In Process Testing

Analytical Technology Transfer

Manufacturing Process Development

Qualification and Validation Process

Release Testing

Terminal Sterilization

In Process Testing

Formulation Development

API Sourcing

Excipient Sourcing

Pre-Clinical Manufacturing

Phase I/II Clinical Manufacturing

Phase III Clinical Manufacturing

Commercial Manufacturing

Product Name

Hazardous

Active Drug or Excipient Name

Select all applies to the formulation

Lipid Nanoparticles (LNP)

RNA (mRNA, Self-Amplified RNA, siRNA)

Empty Liposomes/LNP

Functionalized LNP/Liposome

Antibodies

Protein

Peptides

Pegylated

Oligonucleotide

Antibiotics

Vaccines

Viral

Diluent

In Process Testing

Cytotoxic

Diluent

API Contact Incompatibilities

Any Prior Pre-formulation/Formulation Data Available?

Excipient

Assays Performed

Compendial?

Material(s) to Source by T&T

Material(s) Sourced by Client and Where Are They Sourced From?

Critical Quality Attribute

Temperature Sensitive API or Excipient?

Special Handling During Formulation?

Light Sensitive API or Excipient? (Special Handling)

Oxygen Sensitive API or Excipient?

Inert Atmosphere Necessary?

Shear Sensitive API or Excipient?

Surface Absorbant API or Excipient?

Foaming Sensitive API or Excipient?

Metal or Stainless Steel Sensitive API or Excipient?

Is the API and Aqueous Solution?

Is the API or Excipient Viscous?

API Filterability

Is the API a suspension?

Client Supplying Pre-formulated Material?

Drug Product pH

Material Storage Requirement

Administration Medical Device if Any:

Drug Product Osmolality

Maximum Hold Time Allowed

Specific Tissue or Organ Target

Drug Product Density

Pharmacokinetic - Cmax

Pharmacokinetic - Vd

Drug Product Density

Pharmacokinetic - Dosage

Pharmacokinetic - Cl

Incoming Raw Material Identity Testing

Finished Product Release with CofA

Stability Testing

Sterile Fill, Finish, and Labeling

Fill, Labeling and Finish

Vial Size

Quantity per Batch

Thank you! Your proposal process started. Get ready to be impressed how smooth we make the process for you. We will reach out if any question.

Preclinical Pharmaceutical Development

Preclinical vaccines, and therapeutic developments: Formulation, Analytical Methods, All Manufacturing Processes including technology transfer from your facility to or from T&T Scientific to your facility. Lets get started:

Only fill out related sections to your project. No need to complete every field, our team is ready to help direct your project. If NDA is required and not executed, you can only submit as much as not confidential. We will help you place in an NDA however is preferred by you and your organization.

Is your formulation fully developed?

Have you developed any analytical methods or manufacturing processes for your product?

Does the formulation ready for tech transfer and pharmaceutical development?

What Analytical Methods Have You Already Developed?

Full Name

Value is required

Title

Value is required

Organization Name

Value is required

Organization Address

Value is required

Organization Website

Do you require Confidential Non-Disclosure Agreement?

This field is required

Company Tax ID/VAT

Have you already signed Confidential Non-Disclosure Agreement with T&T Scientific?

This field is required

Click here to download our mutual Non-confidential agreement

Key Parameters

Drug Substance

Lipid Components: Biological/Synthet

Non-Lipid Components

Inactive Ingredient and Buffer

Amount For liquid – mg/ml and mg/vial

Morphology of LNP or Liposomes, etc.

Viscosity

Nanoparticle Size

Transition Temperature of Lipid and API

In Vitro Release of the Drug

Leakage Rate of Drug Shelf Life

Drug Release Amount

Drug Encapsulation Efficiency

Drug Loading

Salt Concentration

Analytical Methods

What Analytical Methods Are You Intending to Complete?

Size

Net Charge - Zeta Potential

Morphology and Lamellarity

Drug Encapsulation Efficiency

Pegylated Contents

Phase Transition Temperature.

In Vitro Release of the Drug Substance from the LNP/Liposome

Leakage Rate of Drug from LNP/Liposomes

Drug Release

Liposome Drug Loading

Manufacturing Processes

What Analytical Methods Are You Intending to Complete?

Microfluidics Solvent or Ethanol Injection

Thin-Film Hydration

Extrusion

Lyophilization and Freeze Drying

High Pressure Homogenization

Sonication

Freeze-thawed

Micro- or Nano- Emulsification

Lyophilization and Freeze Drying

Dried Reconstituted Vesicles

T&T Will Develop for Your Drug

Morphology

What Is the Morphology of Your Nanoparticles?

Lipid Nanoparticle

Liposome

Micelle

Lipoplex

Cationic Lipid Nanoparticle

Ionizable Lipid Nanoparticle

Cationic Nanoemulsions

Pegylated Lipid Nanoparticle

Lipopolyplex

Safety

Do you have Safety Data Sheets?

Have You Validated ICH Viral Vlearance?

Any OSHA Consideration?

Any DEA or EPA Consideration?

Product

Select all that applies to your project

Analytical Method Development In Process Testing

Analytical Technology Transfer

Manufacturing Process Development

Qualification and Validation Process

Release Testing

Terminal Sterilization

In Process Testing

Formulation Development

API Sourcing

Excipient Sourcing

Pre-Clinical Manufacturing

Phase I/II Clinical Manufacturing

Phase III Clinical Manufacturing

Commercial Manufacturing

Product Name

Hazardous

Active Drug or Excipient Name

Select all applies to the formulation

Lipid Nanoparticles (LNP)

RNA (mRNA, Self-Amplified RNA, siRNA)

Empty Liposomes/LNP

Functionalized LNP/Liposome

Antibodies

Protein

Peptides

Pegylated

Oligonucleotide

Antibiotics

Vaccines

Viral

Diluent

In Process Testing

Cytotoxic

Diluent

API Contact Incompatibilities

Any Prior Pre-formulation/Formulation Data Available?

Excipient

Assays Performed

Compendial?

Material(s) to Source by T&T

Material(s) Sourced by Client and Where Are They Sourced From?

Critical Quality Attribute

Temperature Sensitive API or Excipient?

Special Handling During Formulation?

Light Sensitive API or Excipient? (Special Handling)

Oxygen Sensitive API or Excipient?

Inert Atmosphere Necessary?

Shear Sensitive API or Excipient?

Surface Absorbant API or Excipient?

Foaming Sensitive API or Excipient?

Metal or Stainless Steel Sensitive API or Excipient?

Is the API and Aqueous Solution?

Is the API or Excipient Viscous?

API Filterability

Is the API a suspension?

Client Supplying Pre-formulated Material?

Drug Product pH

Material Storage Requirement

Administration Medical Device if Any:

Drug Product Osmolality

Maximum Hold Time Allowed

Specific Tissue or Organ Target

Drug Product Density

Pharmacokinetic - Cmax

Pharmacokinetic - Vd

Drug Product Density

Pharmacokinetic - Dosage

Pharmacokinetic - Cl

Incoming Raw Material Identity Testing

Finished Product Release with CofA

Stability Testing

Sterile Fill, Finish, and Labeling

Fill, Labeling and Finish

Vial Size

Quantity per Batch

Thank you! Your proposal process started. Get ready to be impressed how smooth we make the process for you. We will reach out if any question.

Phase I/II/III Manufacturing & Validations

Have you completed the formulation and moving to clinical studies? Our team is ready to assist you with any phase of clinical trials, and validations required. We will also support with regulatory aspects of manufacturing processes and analytical methods with respect to your country regulatory requirements. We have clinical batch manufacturing world wide including North America, Europe and Asia. Lets get started:

Formulation Completed and Ready for Tech Transfer?

Clinical Phase

Do you need help to complete analytical methods and manufacturing processes plans

Are you looking for alternative supplier or transfring the technology from your company or lab for the first time?

Full Name

Value is required

Title

Value is required

Organization Name

Value is required

Organization Address

Value is required

Organization Website

Do you require Confidential Non-Disclosure Agreement?

This field is required

Company Tax ID/VAT

Have you already signed Confidential Non-Disclosure Agreement with T&T Scientific?

This field is required

Click here to download our mutual Non-confidential agreement

Key Parameters

Drug Substance

Lipid Components: Biological/Synthet

Non-Lipid Components

Inactive Ingredient and Buffer

Amount for Liquid – mg/ml and mg/vial

Morphology of LNP or Liposomes, etc.

Viscosity

Nanoparticle Size

Transition Temperature of Lipid and API

In Vitro Release of the Drug

Leakage Rate of Drug Shelf Life

Drug Release Amount

Drug Encapsulation Efficiency

Drug Loading

Salt Concentration

Analytical Methods

What Analytical Methods Are You Intending to Complete?

Size

Net Charge - Zeta Potential

Morphology and Lamellarity

Drug Encapsulation Efficiency

Pegylated Contents

Phase Transition Temperature.

In Vitro Release of the Drug Substance from the LNP/Liposome

Leakage Rate of Drug from LNP/Liposomes

Drug Release

Liposome Drug Loading

Manufacturing Processes

What Analytical Methods Are You Intending to Complete?

Microfluidics Solvent or Ethanol Injection

Thin-Film Hydration

Extrusion

Lyophilization and Freeze Drying

High Pressure Homogenization

Sonication

Freeze-thawed

Micro- or Nano- Emulsification

Lyophilization and Freeze Drying

Dried Reconstituted Vesicles

T&T Will Develop for Your Drug

Morphology

What Is the Morphology of Your Nanoparticles?

Lipid Nanoparticle

Liposome

Micelle

Lipoplex

Cationic Lipid Nanoparticle

Ionizable Lipid Nanoparticle

Cationic Nanoemulsions

Pegylated Lipid Nanoparticle

Lipopolyplex

Safety

Do you have Safety Data Sheets?

Have You Validated ICH Viral Vlearance?

Any OSHA Consideration?

Any DEA or EPA Consideration?

Product

Select all that applies to your project

Analytical Method Development In Process Testing

Analytical Technology Transfer

Manufacturing Process Development

Qualification and Validation Process

Release Testing

Terminal Sterilization

In Process Testing

Formulation Development

API Sourcing

Excipient Sourcing

Pre-Clinical Manufacturing

Phase I/II Clinical Manufacturing

Phase III Clinical Manufacturing

Commercial Manufacturing

Product Name

Hazardous

Active Drug or Excipient Name

Select all applies to the formulation

Lipid Nanoparticles (LNP)

RNA (mRNA, Self-Amplified RNA, siRNA)

Empty Liposomes/LNP

Functionalized LNP/Liposome

Antibodies

Protein

Peptides

Pegylated

Oligonucleotide

Antibiotics

Vaccines

Viral

Diluent

In Process Testing

Cytotoxic

Diluent

API Contact Incompatibilities

Any Prior Pre-formulation/Formulation Data Available?

Excipient

Assays Performed

Compendial?

Material(s) to Source by T&T

Material(s) Sourced by Client and Where Are They Sourced From?

Critical Quality Attribute

Temperature Sensitive API or Excipient?

Special Handling During Formulation?

Light Sensitive API or Excipient? (Special Handling)

Oxygen Sensitive API or Excipient?

Inert Atmosphere Necessary?

Shear Sensitive API or Excipient?

Surface Absorbant API or Excipient?

Foaming Sensitive API or Excipient?

Metal or Stainless Steel Sensitive API or Excipient?

Is the API and Aqueous Solution?

Is the API or Excipient Viscous?

API Filterability

Is the API a suspension?

Client Supplying Pre-formulated Material?

Drug Product pH

Material Storage Requirement

Administration Medical Device if Any:

Drug Product Osmolality

Maximum Hold Time Allowed

Specific Tissue or Organ Target

Drug Product Density

Pharmacokinetic - Cmax

Pharmacokinetic - Vd

Drug Product Density

Pharmacokinetic - Dosage

Pharmacokinetic - Cl

Incoming Raw Material Identity Testing

Finished Product Release with CofA

Stability Testing

Sterile Fill, Finish, and Labeling

Fill, Labeling and Finish

Vial Size

Quantity per Batch

Thank you! Your proposal process started. Get ready to be impressed how smooth we make the process for you. We will reach out if any question.

Clinical trial vaccines, and therapeutic manufacturing: Is your vaccine or therapeutics formulation development completed and ready for scale up or tech transfer for GMP manufacturing? Our team at T&T is ready to fill any gap in analytical and methods you have already developed and GMP manufacture your pharmaceuticals for clinical trial phase I/II/III. We can support you through the entire clinical studies and commercial batch manufactuLets get started:

Commercial Manufacutirng

Have you completed clinical trials or have generic drugs ready for manufacturing? We have the most capable team to support and plan your commercial GMP manufacturing needs. Lets get started:

Are you looking to alternative manufacturer? (Explain)

Are you looking for a back up manufacturer? (Explain)

Have your drug been approved by the FDA or other appropriate regulatory bodies? (Explain as needed)

How soon would you like to start? (Explain as needed)

Full Name

Value is required

Title

Value is required

Organization Name

Value is required

Organization Address

Value is required

Organization Website

Do you require Confidential Non-Disclosure Agreement?

This field is required

Company Tax ID/VAT

Have you already signed Confidential Non-Disclosure Agreement with T&T Scientific?

This field is required

Click here to download our mutual Non-confidential agreement

Key Parameters

Drug Substance

Lipid Components: Biological/Synthet

Non-Lipid Components

Inactive Ingredient and Buffer

Amount For liquid – mg/ml and mg/vial

Morphology of LNP or Liposomes, etc.

Viscosity

Nanoparticle Size

Transition Temperature of Lipid and API

In Vitro Release of the Drug

Leakage Rate of Drug Shelf Life

Drug Release Amount

Drug Encapsulation Efficiency

Drug Loading

Salt Concentration

Analytical Methods

What Analytical Methods Are You Intending to Complete?

Size

Net Charge - Zeta Potential

Morphology and Lamellarity

Drug Encapsulation Efficiency

Pegylated Contents

Phase Transition Temperature.

In Vitro Release of the Drug Substance from the LNP/Liposome

Leakage Rate of Drug from LNP/Liposomes

Drug Release

Liposome Drug Loading

Manufacturing Processes

What Analytical Methods Are You Intending to Complete?

Microfluidics Solvent or Ethanol Injection

Thin-Film Hydration

Extrusion

Lyophilization and Freeze Drying

High Pressure Homogenization

Sonication

Freeze-thawed

Micro- or Nano- Emulsification

Lyophilization and Freeze Drying

Dried Reconstituted Vesicles

T&T Will Develop for Your Drug

Morphology

What Is the Morphology of Your Nanoparticles?

Lipid Nanoparticle

Liposome

Micelle

Lipoplex

Cationic Lipid Nanoparticle

Ionizable Lipid Nanoparticle

Cationic Nanoemulsions

Pegylated Lipid Nanoparticle

Lipopolyplex

Safety

Do you have Safety Data Sheets?

Have You Validated ICH Viral Vlearance?

Any OSHA Consideration?

Any DEA or EPA Consideration?

Product

Select all that applies to your project

Analytical Method Development In Process Testing

Analytical Technology Transfer

Manufacturing Process Development

Qualification and Validation Process

Release Testing

Terminal Sterilization

In Process Testing

Formulation Development

API Sourcing

Excipient Sourcing

Pre-Clinical Manufacturing

Phase I/II Clinical Manufacturing

Phase III Clinical Manufacturing

Commercial Manufacturing

Product Name

Hazardous

Active Drug or Excipient Name

Select all applies to the formulation

Lipid Nanoparticles (LNP)

RNA (mRNA, Self-Amplified RNA, siRNA)

Empty Liposomes/LNP

Functionalized LNP/Liposome

Antibodies

Protein

Peptides

Pegylated

Oligonucleotide

Antibiotics

Vaccines

Viral

Diluent

In Process Testing

Cytotoxic

Diluent

API Contact Incompatibilities

Any Prior Pre-formulation/Formulation Data Available?

Excipient

Assays Performed

Compendial?

Material(s) to Source by T&T

Material(s) Sourced by Client and Where Are They Sourced From?

Critical Quality Attribute

Temperature Sensitive API or Excipient?

Special Handling During Formulation?

Light Sensitive API or Excipient? (Special Handling)

Oxygen Sensitive API or Excipient?

Inert Atmosphere Necessary?

Shear Sensitive API or Excipient?

Surface Absorbant API or Excipient?

Foaming Sensitive API or Excipient?

Metal or Stainless Steel Sensitive API or Excipient?

Is the API and Aqueous Solution?

Is the API or Excipient Viscous?

API Filterability

Is the API a suspension?

Client Supplying Pre-formulated Material?

Drug Product pH

Material Storage Requirement

Administration Medical Device if Any:

Drug Product Osmolality

Maximum Hold Time Allowed

Specific Tissue or Organ Target

Drug Product Density

Pharmacokinetic - Cmax

Pharmacokinetic - Vd

Drug Product Density

Pharmacokinetic - Dosage

Pharmacokinetic - Cl

Incoming Raw Material Identity Testing

Finished Product Release with CofA

Stability Testing

Sterile Fill, Finish, and Labeling

Fill, Labeling and Finish

Vial Size

Quantity per Batch

Thank you! Your proposal process started. Get ready to be impressed how smooth we make the process for you. We will reach out if any question.