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Developability studies

The journey from discovery to commercialization of new biopharmaceutical drugs is always time-consuming and costly. In this respect, it is of utmost importance to determine decisive factors for a successful lead selection such as manufacturability, biophysical properties and pharmacokinetics as quickly as possible in order to ensure a targeted development.

Biofidus provides a holistic and state-of-the-art developability assessment service for your lead candidates, to accelerate your pipeline and to minimize the risk of later stage setbacks. Our assessment provides a bridge between product knowledge and process understanding. Our developability assessment helps you to optimize the efficacy, safety and overall quality of your biologics at an early stage of development.

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, 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

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IMPURITY ANALYSIS
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AMINO ACID (AA) MODIFICATIONS
draft of two aggregated igG antibodies generated by Biofidus AG
AGGREGATION ANALYSIS
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NUCLEIC ACID 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
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BIOACTIVITY STUDIES
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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
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CELL BASED ASSAYS
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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 inquiries concerning our developability assessments.

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