Laboratory
Analytics of Biologics

Analytics of Biologics

Biologics, also known as biopharmaceuticals, are medicinal products whose active ingredients are derived from living organisms or consist of their components. Due to their high complexity and potential variability in production, the analysis of biologics requires special methods and technologies.

Quality control at the highest level

The analysis of biologics is of crucial importance to ensure the quality, safety and efficacy of the drugs. The structural complexity of biologics is one of the greatest challenges in production and analysis. In contrast to medicinal products with chemical active ingredients, biologics often have very complex three-dimensional structures. Recombinant enzymes or antibodies have specific folds that are essential for their function.

In addition, post-translational modifications such as glycosylation or phosphorylation can strongly influence their activity and stability. Ensuring consistency between different production batches is therefore of the utmost importance, as deviations in production can lead to altered biological activity or even undesirable immunological reactions.

Our range of analytical services

We offer analytical services for biologics and are specialised in particular in the analysis of protein-based medicinal products. As a GMP and FDA-certified outsourcing partner, we have the experience, expertise and technical equipment to offer you analytical testing of biologics.

In addition to chromatographic and electrophoretic techniques such as high-performance liquid chromatography (HPLC) and capillary electrophoresis (CE), high-resolution mass spectrometry plays a particularly important role in the analysis of biologics.

The most important aspects of biologics analysis include characterisation, quality control and quality assurance.

Structural analysis

The determination of the content and identification of the molecular structure, composition and modifications of proteins, in particular post-translational modifications.

Structural analysis

Mass spectrometry
Nuclear magnetic resonance (NMR)
X-ray crystallography

Funktionial analysis

The testing of biological activity to ensure that the product functions as intended.

Funktionial analysis

Bioassays
Measurements of enzyme activity
Cell-based assays

Analysis of glycosylation

Glycosylation patterns are crucial for biologics as they influence efficacy, safety and immune response.

Analysis of glycosylation

High performance liquid chromatography (HPLC)
Capillary electrophoresis (CE)
Mass spectrometry

Purity testing

Ensuring that the biological product is free of impurities such as host cell proteins, DNA or process-related impurities.

Purity testing

Chromatography
Electrophoresis and capillary electrophoresis
Mass spectrometry

Potency determination

Determination of the ability of the biological product to achieve the intended effect, usually by comparison with a reference standard.

Potency determination

Enzyme activity assays
Product-specific assays

Stability testing

Evaluation of the stability of the product under various storage conditions to determine shelf life and maintain efficacy over time.

Stability testing

Assay
Potency
Structure

Weitere Services

In addition to other laboratory services , we also offer drug development, the production of small batches and GxP services. If you have any questions or would like a personal consultation, please do not hesitate to contact us.

Kontaktieren Sie uns. Wir helfen Ihnen gerne!

Christiane Wiegand
Quality Control

Phone: +49 7272 7767-2521
Email: c.wiegand@hwi-group.de

Dr. Sandra Hürtgen
Analytical Development

Phone: +49 7272 7767-2571
Email: s.huertgen@hwi-group.de

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561
Email: sales@hwi-group.de

Fragen und Antworten

Welche Art von Pharmazeutika werden als Biologika bezeichnet?

Biologika oder Biopharmazeutika sind therapeutische Arzneimittel oder Impfstoffe, deren Wirkstoffe bzw. Antigene mit Hilfe gentechnisch veränderter Organismen hergestellt werden. Im Gegensatz zu chemisch synthetisierten Medikamenten sind Biologicals häufig komplexe, große Moleküle. Typische Beispiele sind monoklonale Antikörper, rekombinante Proteine und Nukleinsäure-Präparate zum Beispiel in modernen Impfstoffpräparaten. Diese biologischen Moleküle werden oft durch rekombinante DNA-Technologien in Zelllinien hergestellt. Dazu werden Organismen wie Bakterien, Hefen oder Säugetierzellen genutzt.

Was sind Biosimilars?

Als Biosimilars werden Nachahmerprodukte von Biologika, die keinem Patentschutz mehr unterliegen, bezeichnet. Im Gegensatz zu Generika sind Biosimilars dem Originalpräparat möglichst ähnlich jedoch nicht identisch mit demselben.

Warum ist die Analytik von Biologika ein wichtiges Thema?

Der weltweite Umsatz mit Biologika erreichte im Jahr 2023 etwa 402 Milliarden USD und wird voraussichtlich bis 2030 auf 749 Milliarden USD ansteigen (Coherent Market Insights – Biologics Market). In Deutschland lag 2023 der Anteil der Biologika am Gesamtmarkt von Biopharmazeutika bei knapp 35%, Tendenz steigend. Dieser Markt wird durch die hohe Nachfrage nach biologischen Therapien, vor allem für chronische Erkrankungen wie Krebs und Autoimmunerkrankungen, angetrieben. Besonders monoklonale Antikörper sind ein führendes Segment, da sie gezielt Krankheiten wie Krebs bekämpfen können.