Help you to ensure the quality of your drug products
Release Testing

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

    READ MORE


    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