Logo of BIofidus AG

Comparability studies

Comparability studies play a crucial role in the evaluation of process changes during the manufacturing of biopharmaceutical products. The purpose of comparability studies is to show that the pre- and post-change compounds are comparable in terms of quality, efficacy and safety. Furthermore, comparability studies are required to generate evidence that demonstrates sufficient similarity (not identity) of biosimilars and the originator products with respect to their critical quality attributes (CQAs).
Comparability studies embrace complex and comprehensive analytical pipelines to determine the physicochemical properties, biological activity, product- and process related impurities as well as the stability of pharmaceutical drugs to ensure no adverse impact on their quality, safety and efficacy. Our vast experience and deep knowledge in assessing the impact of heterogeneities allows us to predict if a product will meet consistently approved specifications.

Biofidus offers a holistic and state-of-the-art comparability assessment service according to the ICH Q5 E guideline, to accelerate the approval of your biosimilars or process changes and to minimize the risk of later stage setbacks.

In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your drug substance, its individual formulation matrix and your distinct analytical question.

Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.

Our capabilities

Standalone and integral bioanalytical services

draft of chemical sctructure of a fictive carbon hydrate backbone

PROTEIN SEQUENCE ANALYSIS

draft of 8 rectangularly ordered capsules with one capsule shown upside down
IMPURITY ANALYSIS
draft of chemical sctructure of a fictive carbon hydrate backbone with two phenyl groups
AMINO ACID (AA) MODIFICATIONS
draft of two aggregated igG antibodies generated by Biofidus AG
AGGREGATION ANALYSIS
draft of two igG antibodies one with a circled plus and one with a circled minus to symbolise charge heterogeneities generated by Biofidus AG
CHARGE HETEROGENITY
rectangularly ordered black circles with a few filled and empty ones
BIOACTIVITY STUDIES
twirled black line
HIGHER ORDER STRUCTURE CHARACTERIZATION
draft of igG Antibody with glycosylation pattern at the FC region generated by Biofidus AG
GLYCOSYLATION ANALYSIS
draft of two test tubes connected via a tube to symbolise CE analysis generated by BIofidus
CE ANALYSIS
draft of test tubes in a rack generated by Biofidus AG
CELL BASED ASSAYS
draft of typical SPR binding curves in an xy diagram generated by Biofidus AG
SPR ANALYSIS

Tell us about your project

We‘ll advice you to define your assay needs

By sending the contact form you agree to our privacy policy.
*By submitting this form, you are consenting to receive emails from: Biofidus AG. You can revoke your consent at any time by using the unsubscribe link, found at the bottom of every email. Please see our privacy policy.

Technologies used

Our CEO Dr. Benjamin Müller advices you on all inquiries concerning our comparability assessments.

Phone: +49(0)521 89 739 060
Mail: Benjamin.Mueller@Biofidus.de

WordPress Cookie Plugin von Real Cookie Banner