A rapidly-growing, multi-service, pharmaceutical (CDMO) with expertise in particle engineering, material characterization, analytical testing, early-stage drug development and pre-clinical through clinical manufacturing.
A Multi-Service Pharmaceutical CDMO
CritiTech Particle Engineering Solutions (CT PES) is a rapidly-growing, multi-service, pharmaceutical Contract Development & Manufacturing Organization (CDMO) with extensive experience and expertise in particle engineering, material characterization, analytical testing, early- stage drug development and pre-clinical through clinical manufacturing. CT PES uses two primary technologies to help customers engineer, formulate and manufacture their drugs: Spray Drying and Supercritical Precipitation. CT PES provides a suite of CDMO services from proof-of-concept through Phase III CGMP production. The following are some of the reasons why customers work with CT PES:
- Experts in solubility and bioavailability enhancement
- Proven track record – developed/produced multiple drugs for clinical trials
- Clients include three “Top 15” pharmaceutical companies
- Technical leadership team with >125 years of industry experience
- Highly-skilled, professional, and collaborative technical staff
- Rapid project turnaround times
- Separate facilities for non-cytotoxic and cytotoxic drug production
- Robust particle characterization and analytical capabilities
- In-house QA/QC group
PARTICLE ENGINEERING SERVICES
CT PES offers decades of particle engineering experience and expertise to help its clients develop drugs that meet their desired product specifications (e.g. size, shape, surface area, solubility, dissolution, flowability, efficacy, dosing, route of administration, et. al.). One of CT PES’ specialties is helping clients address bioavailability challenges associated with poorly-soluble drugs. CT PES’ Bioavailability Optimization Team works directly with customers to develop innovative solutions for overcoming solubility problems.
CT PES manufactures non-GMP and CGMP materials using Spray Drying Technology and Supercritical Precipitation Technology. This allows production of milligram quantities to hundreds of kilograms (with both technologies). CT PES also provides process development and scale-up services. Manufacturing services are supported and monitored by an in-house team of experienced quality experts.
**CT PES can manufacture non-cytotoxic, cytotoxic, potent (OEL >0.03 ug/m3), and DEA schedule II-V compounds with their Spray Drying Technology and Supercritical Precipitation Technology.**
CT PES offers non-GMP and CGMP blending, capsule filling and vial filling services for non-cytotoxic, cytotoxic, potent (OEL >0.03) and DEA schedule
ANALYTICAL & MATERIAL CHARACTERIZATION SERVICES
CT PES offers a robust suite of analytical and material characterization services, including analytical method development and validation services, from proof-of-concept through clinical production. Testing data and documentation is reviewed by experienced technical and quality staff to ensure they can be used to support regulatory filings. A full list of CT PES’ analytical services is available at www.crititech.com.