QC release testing of biopharmaceutical products
The emergence of increasing numbers of biotechnology-derived pharmaceuticals has led to the development of a set of specialized tests and assays to determine the identity, quality, purity and potency of this class of drug
Almac has a long-standing status as a center of excellence for pharmaceutical release testing to the highest level of cGMP compliance. This enables us to develop and validate analytical methods, work from pharmacoepial methods and design & execute validation protocols for client methods were appropriate.
Our biopharmaceutical release testing services:
- General pharmacopoeial tests including appearance, osmolarity, pH, etc.
- HPLC assay for purity assessment and related proteins
- Isoelectric Focusing (IEF) for charge heterogeneity analysis
- Peptide mapping using chromatographic, gel electrophoresis and LC-MS methods
- Size Exclusion Chromatography (SEC) for aggregate analysis and molecular size
- Gel electrophoresis (SDS-PAGE; native PAGE; Gel IEF; 2-D PAGE)
- Protein concentration (Folin-Lowry; Bradford; BCA; UV determination; Kjeldahl method)
- Amino acid analysis
- Process-related impurity screening
- Bacterial endotoxins (gel clot method)
- Host cell protein (HCPs) determination – multiplex ELISA
- cGMP Cell-based Bioassays (through our cGMP-accredited partners)
- PK/PD analysis using a validated ELISA for the test biologic
- A parallel study using an ELISA for detection of antibodies raised in the patient against the drug (anti-drug antibodies, or ADA’s)
Additional methods may be available upon client request.