Supporting Protein-Based Drug Products

With Proven Expertise

You understand that your biologic drug must deliver consistent, safe, and effective performance with every batch, but the complexity of large molecules coupled with ever-evolving regulatory demands makes that easier said than done. Whether you’re validating a new production run or scaling up a successful candidate, detailed protein characterisation and analysis are critical to the success of your biologic.

The Eurofins BioPharma Product Testing (BPT) network of laboratories provides expert biochemistry and protein analytics services to help you navigate this complexity. Our global teams specialise in large molecule characterisation using a full suite of orthogonal techniques designed to evaluate identity, purity, heterogeneity, and excipient content. 

We routinely employ these methods to confirm each batch contains the expected proteins in the expected quantities and purity. Our services are designed to meet the needs of developers and manufacturers alike, whether for batch release, formulation development, or production scale-up.

Our streamlined sample logistics and rapid turnaround times help you meet tight development timelines without compromising on data quality. Every project we undertake is overseen by experienced technical teams, ensuring a collaborative, science-first approach from start to finish.

With decades of experience and a deep understanding of protein-based drugs, Eurofins BPT brings clarity to the complexity of biologics. From structural characterisation to excipient stability, we offer you the analytical insight you need to make informed decisions and remain compliant with global regulatory standards. Our clients partner with us for biochemistry and protein analytics that deliver consistent, compliant, and actionable results. 

Tests

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Compendial Tests

(e.g. appearance, clarity, color, pH, osmolality, particulates) 

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Protein concentration

by UV absorbance or SoloVPE

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Purity and identity

by HPLC (RP, SEC, IEX, CEX), CE (reduced & non-reduced), and SDS-PAGE

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Peptide mapping

for identity confirmation

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Capillary Electrophoresis

for heterogeneity

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Glycosylation

(e.g. N-Linked glycan profiling)

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Excipient quantification

including polysorbate 20 and 80