Preclinical Developments

Formulation Optimization

Drug Delivery Systems Design and Characterization

 

Preclinical Development and Formulation Optimization of Nanoparticle Drug Delivery Systems and Nanomedicine Drug Products

At T&T Scientific, we complement the drug discovery process by optimizing concentration, drug delivery compositions and formulations, dosing formulations ahead of efficacy, pharmacokinetic and toxicological preclinical studies by assessing solubility and short-term stability using minimal API to achieve maximum efficacy and quality

Preclinical Development Research Collaboration and Development in Partnership with Companies and Academia

At T&T Scientific, we complement the drug discovery process by optimizing concentration, drug delivery compositions and formulations, dosing formulations ahead of efficacy, pharmacokinetic and toxicological preclinical studies by assessing solubility and short-term stability using minimal API to achieve maximum efficacy and quality; and minimum long term cost. Our expert drug delivery and pharmaceutical scientists along with 15,000 square foot equipped facility allow us to provide most competitive and fast turnaround time with cost-effective services. Our global partners and suppliers for raw materials let source efficiently and effectively for our client's to get the most qualified material at low prices including APIs (DNA, RNA, Small Molecules), and excipients (Lipids, Surfactants, Buffers, and more). In the preclinical and research finalization and optimization formulation at this stage, bioavailability profiles can be improved and the exposure levels achieved during toxicology studies can be enhanced. The preclinical formulation development includes selection of lipids, excipient for drug delivery formulations.

 

Frequently Asked Questions

Services and cGMP CDMO

What Services T&T Scientific Offers to Its Clients?

T&T Scientific Services Include Preclinical Formulations, Manufacturing Processes and Analytical Testing and Methods Development with Focus on Gene Therapy, Drug Delivery, and Nanomedicines Drug Products.

Does T&T Scientific Offer Analytical Studies and Testings?

Yes, T&T Scientific offer range of analytical assays testings and characterizations, as well as analytical methods development with technology transfer capabilities

Competition of Quotation (Overall Costs Relative to Industry Standard):

T&T Scientific offers the most competitive pricing by providing the most streamlined processes of administration and manufacturing in place. Based on Client's Preference T&T Scientific Uniquely and Confidently Offer Two Cost Structures to Its Clients:

  1. Times and Materials Cost Based Structure: Our General Cost Structure and Pricing Is the Industry Most Competitive Price and Rates for Staff Times, and Materials Purchased Are Passed Through Client
  2. Project Long FIXED Cost Structure: Based on Client's Preference, We Also Offer Fully Committed Fix Cost for the Project and Schedule Payments Based on Client''s Preferance.

Does T&T Develop and Tech Transfer Analytical Methods Based on FDA Guidelines and Compliance?

Yes. T&T Scientific develops the complete analytical panels for its client's based on FDA guidelines on Nanomedicines and Gene Therapies, and Vaccines Drug Products.

Do the company offer consulting services?

Yes, certainly, for start of the project and based on our client's preference, we do accept to start the work on consulting basis.

Does T&T Scientific support the animal studies and their material supplies?

Yes, when it comes to manufacturing, T&T Scientific offers to produce small (uLs) to large (10s of Liters +) scale drug products, in most competitive timeline and cost, compliance from preclinical to commercial manufacturing.

Does T&T Scientific support all the manufacturing regulatory works and paper works involved for IND submissions compliant with FDA guidelines?

Yes T&T Scientific Support all paper works required from our CDMO including Master Batch Records (MBR), Batch Record, Protocols, Processes, Certificates of Analysis (CofA), OOS, NCR, and provide comprehensive report of all to the client.

What Analytical Assays Development and Testing T&T Scientific Offers to Its Clients?

Wide Range of Analytical Assays Are Offered by T&T Scientific and its global partners:

What Manufacturing Processes Solutions T&T Scientific Offers to Its Clients?

  1. Solvent Injection and Tangential Flow Filtration (TFF)
  2. Homogenization + Solvent Injection
  3. Tangential Flow Filtration (TFF)
  4. Thin Film Hydration (TFH) + Extrusion
  5. Thin Film Hydration (TFH) + Homogenization (Microfluidizer)
  6. Thin Film Hydration (TFH) + Sonication (Tip and Continual)
  7. Homogenization (Microfluidics)
  8. Sonications (Bath, Continual, and Tip)
  9. Sterile Fill and Finish

What Are T&T Scientific's Strength on Project Management or Client Services?

  1. Weekly Meeting with All Clients Are Scheduled for Project Length
  2. Our Team is Dedicated to Close Relationship with Client's and Daily Response within 24 Hours to Client's Inquiries and Questions.
  3. At T&T Scientific, we are proud of the customer care and focus we provide weekly communication through online meetings and set those up at the time of execution for any proposal. The entire team for the project will be attending those meetings.
  4. Moreover, we always have an on-call person and project manager for our service projects who have deep understanding of the entire process from manufacturing to Quality Control (QC) as well as the compliance and Quality Assurance (QA).

Technologies

What Manufacturing Technologies Are Offered for Sales by T&T Scientific?

T&T Scientific Services Include Preclinical Formulations, Manufacturing Processes and Analytical Testing and Methods Development with Focus on Gene Therapy, Drug Delivery, and Nanomedicines Drug Products.

NanoSizer Extrusion Technologies (MINI, STERILE, AUTOs)

  1. NanoSizer FLOW Solvent Injection Technology Platform (BLINK, CHANNEL, GMP)
    • BLINK: Small Scale from uL to 10s of milliliters
    • CHANNEL: Small Scale from uL to 10s of milliliters Customized with Temperature Control and Inline Dilutions
    • GMP (ALL IN ONE): Small to Large Scale with All Inclusive Capabilities, Industrial Computer, and Software Platform
  1. NanoSizer Extrusion Technologies (MINI, STERILE, AUTOs)
    • MINI: World's First Fully Assembled Low Dead Volume Liposome Extruder
    • STERILE: Sterilized Liposome and Lipid Extruders for Applications that Required Sterility, Such as Cell Works, Exosomes, Etc.
    • NanoSizer AUTO I: Fully Automated Liposome Extruder Ideal with 1-10mL Batch and Runs Sizes
    • NanoSizer AUTO X: Fully Automated Liposome Extruder Ideal with 10mL-200mL Batch and Runs Sizes
    • NanoSizer AUTO Plus: Fully Automated Liposome Extruder Ideal with 10mL-200mL Batch and Runs Sizes

What Concept the Solvent Injection Technology, NanoSizer FLOW, uses to produce Nanoparticle Drug Products?

T&T Scientific FLOW technologies use the turbulent flow mixing Technologies optimized and proprietary technology to manufacture nanoparticle drug products with high quality, high throughput, and low overhead.

Quality Assurance and Quality Control

T&T Scientific Has Been Audited Over Five Times by cGMP Clients and Successfully Addressed All Major and Minor Finding within 30 and 60 days of the Audits, Respectively. There were rare of any major findings during audits performed at T&T Scientific.

Is there an independent Quality Control/Quality Assurance department?

Yes, T&T Scientific does have staff and quality system and department that are independent operated from other departments. The Head of Quality Assurance at T&T Scientific is responsible for compliance of the operation incurs at T&T Scientific; and the Head of Quality Control independently responsible for products quality controls testing and analytics reports. T&T CDMO Space and Sector at T&T Scientific is divided to three independent department of 1) Manufacturing Operations, 2) Quality Assurance, and 3) Quality Control.

What T&T Scientific's Quality Management Systems Are Compliant to?

Each department is a discrete functional unit of the organization, and a quality centric approach is at the core of all that we do here. T&T’s Quality Operations are governed by the site’s Quality Manual. 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 including 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.

What Are the Quality Policies for T&T Scientific?

  • Foster a quality mindset that promotes a passion for continual improvement.
  • Ensure compliance with all applicable regulatory requirements.
  • Guarantee safe and effective products and services that fulfill customers' needs.

Does T&T Scientific Has Electronic Quality Management System?

  • Yes T&T Scientific Utilizes the Top Electronic Quality Management System (Qualio) as Its Electronic Quality Management System Fully Compliant with FDA Requirements.

Does Qualifications and Validation Services Offered for NanoSizer FLOW Technologies

Yes, T&T Scientific Quality Department offer complete installation, training, periodic qualifications and validation services for NanoSizer FLOW technologies.

How Many Times T&T Scientific Have Been Audited in the Past?

T&T Scientific Has Been Successfully Audited Over Five Times by cGMP Small to Large Pharmaceutical Clients and Successfully Addressed All Major and Minor Finding within 30 and 60 days of the Audits, Respectively. There were rare of any major findings during audits performed at T&T Scientific

Does T&T Scientific Have Programs for Task Specific Personnels Training?

T&T Scientific All Under One Roof GMP Manufacturing Has Significant Focus on Staff Training and Its Systematic Training Programs, Matrix Defines, Trains, and Evaluate All Roles Carefully in the Organization.

Does T&T Scientific Perform Recurring Internal and Third Party Self Audits?

T&T Scientific has audits being performed multi time per year internally to assure compliance with latest regulations. These audits are performed by the department of quality assurance and compliance.

 

How Does T&T Scientific Investigate Internal Non-Conforming Operation/Products and Reports?

T&T Scientific Has Been Audited Over Five Times by cGMP Clients and Successfully Addressed All Major and Minor Finding within 30 and 60 days of the Audits, Respectively. There were rare of any major findings during audits performed at T&T Scientific.

Does T&T Scientific, in Regular Basis, Update the SOPs, Protocols, and Procedures?

Yes T&T Scientific Quality Department Meet in regular weekly, monthly, and quarterly and stay up to compliance at all time.

Does T&T Scientific Quality Management System Implemented and Practices Change Control and Complete Traceability?

T&T Scientific Has Been Audited Over Five Times by cGMP Clients and Successfully Addressed All Major and Minor Finding within 30 and 60 days of the Audits, Respectively. There were rare of any major findings during audits performed at T&T Scientific.

Does T&T Scientific Has Compliant Document Control, Retrieval and Storage?

T&T Scientific Has Been Audited Over Five Times by cGMP Clients and Successfully Addressed All Major and Minor Finding within 30 and 60 days of the Audits, Respectively. There were rare of any major findings during audits performed at T&T Scientific.

Manufacturing–Raw Materials / Components Control?

T&T Scientific Has Been Audited Over Five Times by cGMP Clients and Successfully Addressed All Major and Minor Finding within 30 and 60 days of the Audits, Respectively. There were rare of any major findings during audits performed at T&T Scientific.

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Pharmaceutical Technology Transfers and Development

Manufacturing Processes and Analytical Methods Development from Preclinical to cGMP Clinical and Commercialization

Technology transfer to T&T Scientific Contract Development and Manufacturing Organization (CDMO) includes the efforts of formulation, quality, and manufacturing departments teams from the start of preclinical or clinical batches through commercialization activities and throughout the life cycle of a product. During the selection process, we work closely with clients on critical areas that will need CDMO in preparation for the Statement of Work (SOW). This process can be during preclinical, phase I, phase II, and phase III clinical trials. The tech transfer process includes receiving all developed information from clients' research and lab results, risk assessment, manufacturing process development, analytical methods, and capturing information in development reports that prepare for regulatory and Investigational New Drug (IND) Application submission.

At our team in T&T Scientific, it is essential that a technology transfer team include cross-functional subject matter experts in the fundamental science of nanoparticles, analytics, technology, regulatory, manufacturing, and compliance in different departments of our company. T&T set up weekly meetings with clients' representatives to provide updates on all previous week's activities, improvements, challenges, ideas, and paths forward for short and long terms.

Frequently Asked Questions

Services

What Services T&T Scientific Offers to Its Clients?

T&T Scientific Services Include Preclinical Formulations, Manufacturing Processes and Analytical Testing and Methods Development with Focus on Gene Therapy, Drug Delivery, and Nanomedicines Drug Products.

Does T&T Scientific Offer Analytical Studies and Testings?

Yes, T&T Scientific offer range of analytical assays testings and characterizations, as well as analytical methods development with technology transfer capabilities

Competition of Quotation (Overall Costs Relative to Industry Standard):

T&T Scientific offers the most competitive pricing by providing the most streamlined processes of administration and manufacturing in place. Based on Client's Preference T&T Scientific Uniquely and Confidently Offer Two Cost Structures to Its Clients:

  1. Times and Materials Cost Based Structure: Our General Cost Structure and Pricing Is the Industry Most Competitive Price and Rates for Staff Times, and Materials Purchased Are Passed Through Client
  2. Project Long FIXED Cost Structure: Based on Client's Preference, We Also Offer Fully Committed Fix Cost for the Project and Schedule Payments Based on Client''s Preferance.

Does T&T Develop and Tech Transfer Analytical Methods Based on FDA Guidelines and Compliance?

Yes. T&T Scientific develops the complete analytical panels for its client's based on FDA guidelines on Nanomedicines and Gene Therapies, and Vaccines Drug Products.

Do the company offer consulting services?

Yes, certainly, for start of the project and based on our client's preference, we do accept to start the work on consulting basis.

Does T&T Scientific support the animal studies and their material supplies?

Yes, when it comes to manufacturing, T&T Scientific offers to produce small (uLs) to large (10s of Liters +) scale drug products, in most competitive timeline and cost, compliance from preclinical to commercial manufacturing.

Does T&T Scientific support all the manufacturing regulatory works and paper works involved for IND submissions compliant with FDA guidelines?

Yes T&T Scientific Support all paper works required from our CDMO including Master Batch Records (MBR), Batch Record, Protocols, Processes, Certificates of Analysis (CofA), OOS, NCR, and provide comprehensive report of all to the client.

What Analytical Assays Development and Testing T&T Scientific Offers to Its Clients?

Wide Range of Analytical Assays Are Offered by T&T Scientific and its global partners:

What Manufacturing Processes Solutions T&T Scientific Offers to Its Clients?

  1. Solvent Injection and Tangential Flow Filtration (TFF)
  2. Homogenization + Solvent Injection
  3. Tangential Flow Filtration (TFF)
  4. Thin Film Hydration (TFH) + Extrusion
  5. Thin Film Hydration (TFH) + Homogenization (Microfluidizer)
  6. Thin Film Hydration (TFH) + Sonication (Tip and Continual)
  7. Homogenization (Microfluidics)
  8. Sonications (Bath, Continual, and Tip)
  9. Sterile Fill and Finish

What Are T&T Scientific's Strength on Project Management or Client Services?

  1. Weekly Meeting with All Clients Are Scheduled for Project Length
  2. Our Team is Dedicated to Close Relationship with Client's and Daily Response within 24 Hours to Client's Inquiries and Questions.
  3. At T&T Scientific, we are proud of the customer care and focus we provide weekly communication through online meetings and set those up at the time of execution for any proposal. The entire team for the project will be attending those meetings.
  4. Moreover, we always have an on-call person and project manager for our service projects who have deep understanding of the entire process from manufacturing to Quality Control (QC) as well as the compliance and Quality Assurance (QA).

Technologies

15,000 SQ.FT. ALL UNDER ONE-ROOF GMP OPERATION

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