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CritiTech Particle Engineering Solutions, LLC

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Lawrence, Kansas, US

About CritiTech Particle Engineering Solutions, LLC

CritiTech Particle Engineering Solutions (CT PES) is an established, growing, pharmaceutical Contract Development Manufacturing Organization (CDMO) with extensive experience and expertise in particle engineering, material characterization, analytical testing, early stage drug development, pre-clinical and... Show more »

CritiTech Particle Engineering Solutions (CT PES) is an established, growing, pharmaceutical Contract Development Manufacturing Organization (CDMO) with extensive experience and expertise in particle engineering, material characterization, analytical testing, early stage drug development, pre-clinical and clinical manufacturing. The company utilizes Spray Drying and Supercritical Precipitation to help its customers develop their drugs. CT PES provides its drug development and manufacturing services from proof-of-concept through Phase II cGMP production. Clients range from “Top 15” pharmaceutical companies to pharmaceutical and biotechnology start-ups.

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Our Services (35)


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Particle Engineering

Price on request

CritiTech Particle Engineering Solutions (CT PES) combines its particle engineering experience and technologies, Spray Drying and Supercritical Precipitation, to help our clients develop their drugs and achieve their desired product profiles. One of CT PES’ specific strengths is addressing the solubility and bioavailability... Show more »

CritiTech Particle Engineering Solutions (CT PES) combines its particle engineering experience and technologies, Spray Drying and Supercritical Precipitation, to help our clients develop their drugs and achieve their desired product profiles. One of CT PES’ specific strengths is addressing the solubility and bioavailability challenges relating to poorly-soluble compounds. Our customers use our particle engineering expertise and technologies to meet their product specifications including, but not limited to:

• Particle Size
• Particle Shape
• Crystalline and/or Amorphous Phase
• Surface Area
• Dissolution
• Flowability
• Efficacy
• Toxicity
• Dosing
• Route of Administration

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Spray Drying

Price on request

CritiTech Particle Engineering Solutions offers spray drying services from proof-of-concept through Phase II cGMP production for aqueous and organic solvent soluble materials.

Features
• Spray-dried dispersions (amorphous API + polymer)
• Spray-dried precipitates (crystalline or amorphous API alone)
• Spray from aqueous or... Show more »

CritiTech Particle Engineering Solutions offers spray drying services from proof-of-concept through Phase II cGMP production for aqueous and organic solvent soluble materials.

Features
• Spray-dried dispersions (amorphous API + polymer)
• Spray-dried precipitates (crystalline or amorphous API alone)
• Spray from aqueous or organic solvent systems
• Non-potent API
• Non-cytotoxic API
• Potent API
• Cytotoxic API (dedicated room, equipment, and air handling system)
• Cytotoxic and non-cytotoxic cGMP materials produced in separate facilities
• Continuous processing
• Develop multiple formulations with grams of API
• Milligrams to hundreds of kilograms production scale
• Data from Buchi or Mobile Minor can be easily transferred to CT PES

Benefits
• Bioavailability enhancement of poorly soluble drugs (BCS Class II and IV)
• Applicable for peptides and biologics
• CritiTech’s single pass nitrogen systems ideally suited for the following types of drugs
- Oxygen sensitive
- Vulnerable to abrasion or shearing
- High crystal lattice energy
• Potential to improve pharmacokinetics
• Can be utilized as a LCM tool for a reformulated and improved 2nd generation product
• Particles engineered for multiple routes of delivery
• Scalable and reproducible

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Drug Development

Price on request

Crititech Particle Engineering Solutions (CT PES) helps its customers develop new drugs and improved reformulations of existing drugs [505(b)(2)] from proof-of-concept through Phase II cGMP clinical production. CT PES manufactures non-GMP and cGMP materials using its Spray Drying Technology and proprietary Supercritical... Show more »

Crititech Particle Engineering Solutions (CT PES) helps its customers develop new drugs and improved reformulations of existing drugs [505(b)(2)] from proof-of-concept through Phase II cGMP clinical production. CT PES manufactures non-GMP and cGMP materials using its Spray Drying Technology and proprietary Supercritical Precipitation Technology. Our drug development services are supported and reviewed by an experienced, in-house team of quality experts. CT PES can produce the following types of materials:

•Non-cytotoxic compounds
•Potent compounds down to OEL >0.03 µg/m3
•DEA Schedule II-V compounds
•Milligrams to hundreds of kilograms

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Manufacturing Services

Price on request

CritiTech Particle Engineering Solutions (CT PES) manufactures non-GMP and cGMP materials using its Spray Drying Technology and Supercritical Precipitation Technology. Our manufacturing services are supported and reviewed by an experienced, in-house team of quality experts. CT PES can produce the following types of... Show more »

CritiTech Particle Engineering Solutions (CT PES) manufactures non-GMP and cGMP materials using its Spray Drying Technology and Supercritical Precipitation Technology. Our manufacturing services are supported and reviewed by an experienced, in-house team of quality experts. CT PES can produce the following types of materials:

• Non-cytotoxic compounds
• Potent compounds down to OEL >0.03 µg/m3
• DEA Schedule II-V compounds
• Milligrams to hundreds of kilograms

In regard to our spray drying manufacturing services, your existing processing parameters from a Buchi or Mobile Minor are compatible with and can easily be transferred to CT PES for production at our facilities.

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Material Testing Services

Price on request

CritiTech possesses the following analytical capabilities to support the analysis and characterization of nanoparticulate particles:

  • Particle Size Analysis
    • Laser Diffraction
    • Light Obscuration
  • Sorptometry
    • BET
  • Residual Solvent Determination
    • Gas Chromatography
  • Identification

CritiTech possesses the following analytical capabilities to support the analysis and characterization of nanoparticulate particles:

  • Particle Size Analysis
    • Laser Diffraction
    • Light Obscuration
  • Sorptometry
    • BET
  • Residual Solvent Determination
    • Gas Chromatography
  • Identification
    • FTIR
    • HPLC
    • UV/Vis Spectroscopy
  • Moisture Determination
    • Karl Fischer Titration
  • X-Ray Powder Diffraction
  • Calorimetry
    • DSC
  • Imaging
    • Optical microscopy with digital image analysis
    • Scanning Electron Microscopy
    • Transmission Electron Microscopy
  • Quantification and Purity
    • HPLC (UV & PDA)
    • UV/Vis Spectroscopy
  • Dissolution
    • USP Apparatus 2
  • Potentiometric Titration
  • Optical Activity
    • Polarimetry
  • Stability Testing (in house Q1 – 2018) ICH Conditions
    • Accelerated
    • Intermediate
    • Long Term
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Particle Analysis and Characterization

Price on request

CritiTech possesses the following analytical capabilities to support the analysis and characterization of nanoparticulate particles:

  • Particle Size Analysis
    • Laser Diffraction
    • Light Obscuration
  • Sorptometry
    • BET
  • Residual Solvent Determination
    • Gas Chromatography
  • Identification

CritiTech possesses the following analytical capabilities to support the analysis and characterization of nanoparticulate particles:

  • Particle Size Analysis
    • Laser Diffraction
    • Light Obscuration
  • Sorptometry
    • BET
  • Residual Solvent Determination
    • Gas Chromatography
  • Identification
    • FTIR
    • HPLC
    • UV/Vis Spectroscopy
  • Moisture Determination
    • Karl Fischer Titration
  • X-Ray Powder Diffraction
  • Calorimetry
    • DSC
  • Imaging
    • Optical microscopy with digital image analysis
    • Scanning Electron Microscopy
    • Transmission Electron Microscopy
  • Quantification and Purity
    • HPLC (UV & PDA)
    • UV/Vis Spectroscopy
  • Dissolution
    • USP Apparatus 2
  • Potentiometric Titration
  • Optical Activity
    • Polarimetry
  • Stability Testing (in house Q1 – 2018) ICH Conditions
    • Accelerated
    • Intermediate
    • Long Term
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Gas Chromatography (GC)

Gas Chromatography
Price on request
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FT-IR

Fourier transform infrared spectroscopy
Price on request
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HPLC

High Performance Liquid Chromatography
Price on request
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UV-VIS Spectroscopy

Price on request
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Karl Fischer Titration

Price on request
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X-Ray Powder Diffraction

Price on request
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Differential Scanning Calorimetry (DSC)

Price on request
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Transmission Electron Microscopy (TEM)

Transmission Electron Microscopy services
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Scanning Electron Microscopy (SEM)

Scanning Electron Microscopy services
Price on request
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Optical Microscopy

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Solubility and Dissolution Testing

Price on request

USP Apparatus 2

USP Apparatus 2

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Analytical Chemistry Services

Price on request

Analytical Chemistry Services

Analytical Chemistry Services

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Chemical Stability Testing

Price on request

Stability Testing (in house Q1 – 2018) ICH Conditions

  • Accelerated
  • Intermediate
  • Long Term

Stability Testing (in house Q1 – 2018) ICH Conditions

  • Accelerated
  • Intermediate
  • Long Term
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Chemistry and Materials

Price on request

Chemistry and Materials Services

Chemistry and Materials Services

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Formulation Services

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Formulation Services

Formulation Services

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Electron Microscopy

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Electron Microscopy Services

Electron Microscopy Services

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Microscopy

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Microscopy Services

Microscopy Services

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Imaging & Spectroscopy

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Imaging & Spectroscopy Services

Imaging & Spectroscopy Services

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Calorimetry

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Calorimetry Services

Calorimetry Services

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Physical Analysis Methods

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Physical Analysis Methods Services

Physical Analysis Methods Services

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Engineering and Fabrication

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Engineering Services

Engineering Services

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Spectrophotometry

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Spectrophotometry Services

Spectrophotometry Services

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Spectroscopy

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Spectroscopy Services

Spectroscopy Services

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Liquid Chromatography (LC)

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Liquid Chromatography Services

Liquid Chromatography Services

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Chromatography

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Chromatography Services

Chromatography Services

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Separation/Purification Services

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Purification Services

Purification Services

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Infrared Spectroscopy Services

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Infrared spectroscopy services Services

Infrared spectroscopy services Services

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Fabrication and Materials Processing Services

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Fabrication Services

Fabrication Services

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Drug Discovery & Development

Price on request

Drug Discovery & Development Services

Drug Discovery & Development Services

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Matthew McClorey

President

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