Release Testing
Protagen Protein Services (PPS) provides release testing for our customers since many years including a broad and steadily increasing number of available methods including also mass spectrometry. After GMP method validation release testing with fixed specifications on e.g. identity, content, purity, impurity or activity is performed with quick turn-around times. We provide release testing for the EU, US and other regulatory markets.
PPS has long-standing experienced in:
- Developing and validating state-of-the-art analytical methods for release testing
- Transferring release methods to clients site
- Working with client supplied methods, literature or pharmacopoeia methods
Release testing encompasses a variety of previously validated studies to demonstrate product compliance and to ensure consistency in product activity, identity and purity. It is a crucial step in the release of the final product to the market.
Typical release tests are detailed in the table below.
ICH Q6B category | Goal | Analytical method | DS | DP |
General tests | pH, osmolality, volume, Appearance | pH, osmolality, volume, visible particles, appearance of powder | x | x |
Appearance and description | Color and clarity | Coloration, clarity, opalescence | x | x |
Structural integrity, identity and heterogeneity | Primary structure | Peptide map | x |
|
Charged variants | IEF, IEX, cIEF, CZE | x | x | |
Glycosylation | Glycan mapping, monosaccharides e.g. HPLC | [x] | [x] | |
Purity (process and product related) | Fragments | SDS-PAGE, CGE, RP-HPLC, SEC | x | x |
Aggregates | SEC | x | x | |
Protein variants, PTMs | RP-HPLC, IEF, IEX, cIEF, CZE / peptide mapping | (x) | (x) | |
HCP, DNA | HCP-ELISA, assay for DNA | (x) |
| |
particulate contamination/ matter | Pharmacopeia methods |
| (x) | |
Potency | Potency | Bioassay | x | x |
Quantity | Protein content | UV scan, AAA,... | x | x |
SERVICES
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science regarding characterization, method development, validation and routine testing of antibodies, proteins, vaccines and other formates of biopharmaceuticals. Our sites are equipped with modern, state-of-the-art equipment for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, thermal stability e.g.. We offer service modules for analytcal support from research to approval regarding:
- Developability
- Clone Selection & Process Development
- Extendend Characterization & Comparability
- Stability & Release
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science. More than 20 years of market experience and the comprehensive spectrum of validated analytical methods ensure the highest quality for customers in the pharmaceutical, biotech and life science industry.
PPS supports Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity
