PTL offers characterisation of proteins by various high end techniques for impurity identification and characterization, higher order structural characterization and biological assays by cell-based, binding or other types of assays, including in-vivo assays.
We can provide custom packages for protein characterization to support your IND and Biosimilar application.
All quality control testing, starting with raw material testing, in-process testing to finished product testing, environmental and water quality monitoring, microbiological testing, and product lot release and stability testing is carried out in compliance with global GMP standards.
Biologic Characterisation and Quality Control group provides the following services:
- Analytical method transfer or development followed by qualification.
- Analytical method validation (ICH Q2R1).
- Potency determination by in-vitro cell based assays, non-cell based assays (ligand binding assay) and in-vivo assays, including bioassay validation as per pharmacopoeial guidelines.
- Biochemical Analysis.
- Protein quantitation.
- Immunological assays.
- HPLC and UPLC-based assays for related substances and charged variants.
- Process residuals such as Protein A or other additives.
- Aggregate analysis by SEC and DLS.
- Process related impurities such as Host cell protein and Host cell DNA.
- Electrophoresis including Capillary electrophoresis and imaged capillary electrophoresis.
- Glycoform analysis including monosaccharide composition, glycan structure, glycosylation site determination by peptide maps, LC-MS/MS and NP-HPLC.
- Peptide mass fingerprinting and amino acid sequencing.
- Impurity characterization.