CritiTech Particle Engineering Solutions (CT PES) is a growing, pharmaceutical Contract Research Organization (CRO) and 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. 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.
Why Choose CT PES?
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
• Route of Administration
CritiTech Particle Engineering Solutions offers spray drying services from proof-of-concept through Phase II cGMP production for aqueous and organic solvent soluble materials.
• 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
• 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
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
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:
•Potent compounds down to OEL >0.03 µg/m3
•DEA Schedule II-V compounds
•Milligrams to hundreds of kilograms
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.
CritiTech Particle Engineering Solutions (CT PES) provides a robust suite of non-GMP and cGMP material characterization and analytical services to support our clients drug development projects from proof-of-concept through clinical production. Our testing data and documentation is reviewed by experienced technical and quality staff to ensure they can be used to support regulatory filings. The following is a list of CT PES’ material characterization and analytical services:
CritiTech possesses the following analytical capabilities to support the analysis and characterization of nanoparticulate particles:
Stability Testing (in house Q1 – 2018) ICH Conditions
Infrared spectroscopy services Services
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