General Quality Control Services
- Pharmaceutical waters (PW, WFI, CS) testing
- Critical systems (N2 distribution, compressed air distribution) testing
- Environmental monitoring of classified areas (Class A, B, C and D)
- Raw materials testing and release
- Primary packaging materials testing and release
- Secondary packaging materials testing and release
- Active Pharmaceutical Ingredient (DS) analyses
- In-Process Control (IPC)
- Final product (DP) analyses
- Complete development, qualification and validation of analytical methods to
comply with international guidelines (ICH, EMA, FDA, etc.). - Transfer of analytical methods (<1224> USP)
- Implementation and verification of Compendial methods (Eur. Ph., USP,
international Pharmacopoeias) - Stability studies according to international guidelines (ICH, WHO, etc.)
Physicochemical and Biochemical laboratory
- Potentiometric analyses (pH, conductivity)
- Osmolality
- Total organic carbon (TOC)
- Water content (Karl-Fischer)
- High performance liquid chromatography (HPLC): peptide mapping, SEC,
impurities, excipients, purity, assay - Gas chromatography (GC)
- UV-Vis spectrophotometry
- UV-Vis microplate reader
- Sub-visible particles
- Total protein (Bradford, BCA, extinction coefficient, etc.)
- Zeta potential
- Micro and nano-particles size distribution
- Electrophoresis SDS-PAGE
- ELISA
- Western Blot
- Isoelectric focusing (IEF)
Partners for other protein characterization testing
Liof Pharma can manage and coordinate the following analytical services:
- Microbiological tests (bioburden, Gram, etc.)
- Genetic stability (G-branding, CGH, etc.)
- Flow cytometry
- Mycoplasma
- Impurity controls
- PCR/qPCR
- Cell viability (MTT)
- Sterility (filtration, BacT-Alert)
- Master and Working Cell Bank characterization (identity, purity, viability, genetic stability)
- HPLC-MS
- GC-MS
- Atomic Spectroscopy
- FTIR
- Hydrolytic Resistance