Release Testing
Release Testing
Protagen AG provides release testing for the EU, US and other regulatory markets.
Protagen AG 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 |
Your contact for Release Testing at Protagen AG
 |
Dr Katja AschermannHead of Business Development Protein Services. Phone: +49 (0) 231 9742-6300 |