Analytical Testing & Technical Service
Medicine for the Future Today
Our analytical method development
We establish precise analytical test methods to ensure the integrity of your product. In the the early-stage drug products we manufacture are often first-in-clinical, first-in-human products. This makes sterility assurance and safety data critical. We work to develop reliable test methods for factors like potency, percent encapsulation and degradation customized for your drug’s manufacturing and storage conditions.
Analytical Technical Services
Analytical Method Development & Troubleshooting and Process Development Analytical Support
Method Qualifications / Validations / Transfers
API and Raw Material Testing Per USP/NF/Ph.Eur.
Sterile Injectable In-Process and Finished Drug Product Testing
API, Raw Material, In-Process, and Finished Product Specification Development
ICH and cGMP Stability Testing
Complex Drug Product Testing for LNPs & Pegylated Formulations Involving Oligonucleotides, Proteins, Small & Other Large Molecules
Dedicated Development Team of Highly Experienced, Qualified and Trained Scientists
Dedicated Staff for cGMP & QC Routine Testing
Analytical Instrumentation and Equipment
Multiple Waters Brand HPCLs and UPLCs with UV-PDAs / CADs / ELSDs / RI / Fluorescence, QDa, Single Quadrupole Mass Spectrophotometer & Multi Angle Light Scattering (SEC-MALS) Detectors
Fluorescence/UV/Nanodrop/FT-IR Spectrophotometers
CE/Fragment Analyzers
ELISA Plate Readers
Malvern Zetasizers (Nano S, Nano ZS90) & Mastersizer 2000
Agilent Gas Chromatographs with FID/ECD/TCD Detectors & Headspace GC/FID
SDS-PAGE and Western Blot
Polarography Analyzer, Coulometric & Volumetric Karl Fishers, Auto Titrator
Centrifuges, Micro & Analytical Balances
-800C & -200C Freezers
Multiple c-GMP Stability Chamber
2-8C (walk-in)
23-27C/55-65%RH (two chambers)
-15C to -25C (two chambers)
-65C to -85C (one upright
Drug Product Assay & Impurities
Concentration Assays via HPCL & UPLC-UV/CAD, ELISA Assays for Proteins in LNPs & Pegylated Formulations
Enzymatic Activity for PEGylated Proteins via UPLC/UV
Ribogreen Assays for RNAs and Oligreen Assays for DNAs
Drug Product Purity & Impurities via UPLC, SEC, CE/Fragment Analyzer
Residual Solvents via GC Headspace, GC-FID, GC-ECD and GC-TCD
In-Vitro Release (IVR) Assays
Lipids Assay & Impurities via HPLC & UPLC-CAD/ELSD/UV
We have assisted clients in Australia and internationally to translate their discoveries into commercial entities utilizing experienced scientists as well as regulatory personnel, IP specialists and Australian Government Research Grant advisors.
The Purecell Group based in Sydney and Melbourne, Australia is a Translational Research Centre. Our group specializes in taking projects and products from the bench top to the final product. Utilizing its extensive experience across a wide range of scientific research, regulatory requirements as well as clinical trial design and implementation, the PCG can assist clients in the development and commercial translation of a range of medical and scientific.
CONFIDENTIALLITY STATEMENT
Information confidentiality between TRC@PG and its clients.
