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Bispecific Antibodies

The unique feature of bispecific antibodies (BsAbs) is that they combine at least two antigen-binding elements from different antibodies within a single molecule. A variety of different ways exist, to unify the properties of multiple antibodies in one BsAb, making the evaluation and characterization of critical quality attributes (CQAs) for these subclasses particularly sensitive. In this regard, our experienced experts place special emphasis on compliance with all relevant CQAs.

Biofidus provides a broad range of state-of-the-art analytical techniques to support your biologics development or biosimilar comparability study. We cover the structural as well as the functional characterization of proteins allowing us to provide you with a complete analytical package for your analytical challenge.

Our analytical portfolio includes in-depth analysis of the protein primary structure, amino acid modifications, impurities like homodimers as well as  binding or functionality in cell-based assays. We are specialists in determining protein glycosylation structures, which are among the most important protein modifications that can have significant influence on function and stability of biopharmaceutical molecules.

Our vast experience and deep knowledge in this field allows us to guide you through the variety of available methods and help you find the optimal analytical solution for your project.

In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your drug substance (DS), 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

Protein Sequence Analysis

PROTEIN SEQUENCE ANALYSIS

Impurity Analysis
IMPURITY ANALYSIS
Amino Acid Modifications
AMINO ACID (AA) MODIFICATIONS
Aggregation Analysis
AGGREGATION ANALYSIS
Charge Heterogenity
CHARGE HETEROGENITY
Bioactivity
BIOACTIVITY STUDIES
Higher Order Structure
HIGHER ORDER STRUCTURE CHARACTERIZATION
lycosylation Analysis
GLYCOSYLATION ANALYSIS
CE Analysis
CE ANALYSIS
Cellbased Assay
CELL BASED ASSAYS
SPR Analysis
SPR ANALYSIS

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

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Technologies used

Our CEO Dr. Benjamin Müller advices you on all your requests concerning the general topic of protein characterization.

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

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