Protagen Protein Services GmbH provides release testing for the EU, US and other regulatory markets.

Protagen Protein Services GmbH 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 Protein Services GmbH

Thomas Flad

Dr Thomas Flad

Director Business Development
Our business development team will be happy to assist you with your project.

Phone: +49 (0) 231 9742-6100
Email: salesproteinservices@ProtagenProteinServices.com