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Biosimilar studies

Experience top-tier biosimilar study services with Biofidus. Our biosimilar assessments focus on generating evidence that showcases the significant similarity (not identity) between biosimilars and originator products, specifically concerning critical quality attributes (CQAs).

Our biosimilar studies feature intricate and comprehensive analytical pipelines. We delve into physicochemical properties, biological activity, product- and process-related impurities, and pharmaceutical drug stability to ensure no adverse impacts on quality, safety, and efficacy. Drawing on our extensive experience and profound knowledge of assessing heterogeneities, we can predict a product’s consistency in meeting approved specifications.

Biofidus offers a holistic and state-of-the-art biosimilar and comparability assessment service according to the ICH Q5E 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

Extensive experience with :

Biofidus_Biosimilar Experience

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
DNA

DNA/RNA SEQUENCING

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

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 comparability assessments.

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

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