QC testing of large molecules (DS/DP)

Expert QC testing for large molecules

Prior to commercial drug release, quality can be negatively affected by various factors during production and other stages of the process. Our teams are well-equipped, trained and rigorously inspected to support our clients with highest standards in QC testing of large molecules.

We have experience in testing large molecules, including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), bi/trispecific mAbs, and vaccines as well as biosimilars and biogenerics.

3D illustration of antibodies , large molecule drugs, Biologics

Compendial tests

We offer comprehensive compendial testing services for both active pharmaceutical ingredients (APIs) and drug products. These services adhere to established pharmacopoeial standards, including tests for assay, impurities, identification, dissolution, sterility and more.

Non-compendial tests

In contrast to compendial methods, non-compendial analytical methods require elaborate method development according to the product’s quality attributes and subsequent validation within the testing site. We offer customised development and validation/ transfer of methods for a vast variety of non-compendial quality control (QC) testing services for various kinds of large molecules in different stages of development as well as after commercialisation.

ELISA

Enzyme-linked immunosorbent assay (ELISA) is a widely used laboratory technique for detecting and quantifying specific proteins, antibodies, antigens or hormones in biological samples. The method relies on the principle of antigen-antibody binding, combined with an enzyme-conjugated secondary antibody that produces a detectable signal.

Nuvisan offers ELISA testing as part of our comprehensive bioanalytical services, particularly for the pharmaceutical and biotechnology industries.

In a typical ELISA procedure, a sample is added to a microplate well coated with a specific antigen or antibody. After binding occurs, an enzyme-linked secondary antibody is introduced. This enzyme reacts with a substrate, producing a color change or fluorescence, which can then be quantified, allowing researchers to measure the concentration of the target molecule in the sample.

Nuvisan’s ELISA testing services support both qualitative and quantitative analysis of complex biological molecules, offering high sensitivity, reproducibility and robust data to guide decision-making in drug development and clinical trials.

Qualification of standard and reference materials

To support high-quality analytical testing, an independent supply of standard and reference materials is essential. The qualification, storage and re-qualification of these materials is one of the benefits we offer in our labs. The materials are qualified in compliance with the current effective regulations.