• Chromatographic methods
• Titration testing procedures
• Identity testing
and assay, purity
testing and drug release
• In vitro dissolution testing
|
• Batch release testing / quality control
• Stability studies and stability storage facilities
(25⁰C/60%, 30⁰C/65%, 30⁰C/75%, 40⁰C/75%,
2-8⁰C)
• Photostability studies |
• Extractables / leachables
studies
• Potentially genotoxic impurities (PGI)
• Cleaning validation studies
• Elemental impurities (EI)
• Residual
solvents (RS)
• Troubleshooting & root cause
analysis : impurities
from production processes
• Structure elucidation
using mass spectroscopy and NMR
• Modern analytical physical
methods, |
• Comprehensive risk based evaluation of product quality regarding analytical questions
• Review of specifications, analytical procedures, validation reports according to
up-to-date scientific knowledge and regulatory requirements
• Gap analysis of module 2.3/3 together with our regulatory, drug development and production experts |
• Isolation and qualification of pharmaceutical reference standards in accordance with all legal and regulatory requirements in the GMP environment
• Qualification of pharmaceutical reference standards including dossier preparation for submission in 3.2.P.5.6
• Assay standards
• Primary reference standards (complete documentation)
• Working standards (batch- related CoA)
• Ident- and purity standards
|
• Determination
of the primary
structure of proteins, oligonucleotides
• Colourimetric,
fluorescence and
activity assays
• Determination
of process-related
impurities
• Determination
of chemical
modifications
(PEGylation,
mRNA capping)
• Batch variant
analysisLipid
nanoparticles
(RNA), aptamers
• Lipid nanoparticles (RNA), aptamers |
