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Lead and clone selection

Intelligent and targeted lead and clone selections are unquestionably important fundamentals during the development of biologics or biosimilars as they have an immense impact on the development time and thus on the associated costs of the project.

The first stage of selection focusses on a detailed evaluation of suitable lead molecules that have the most desirable properties with respect to high efficacy, low toxicity, as well as suitable pharmacokinetics.
For an economically optimized production of these selected lead candidates, it is essential to select the most promising clones in the further course of drug development, which show consistently high product yields and qualities. Factors such as impurities caused by host cell proteins (HCPs), glycosylation patterns or other post-translational modifications of the protein-based drugs are fundamental critical quality attributes (CQAs) to characterize the functionality, immunogenicity and overall safety of the product.

Biofidus offers a holistic and state-of-the-art analytical service platform for a high-throughput screening of your lead molecules in order to accelerate the development of your biologic or biosimilar.

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

bioanalytical services

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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
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
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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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Our CEO Dr. Benjamin Müller advices you on all inquiries concerning our lead and clone selection services.

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

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