Prolytic cGLP ELISA tests for ADA anti drug antibodies

Overview

As a bioanalysis specialist, Prolytic has developed particular expertise and capabilities that can deliver GLP compliant (cGLP) enzyme-linked immunosorbent assay (ELISA) analyses that can quantify proteins, antibodies, antigens, ADAs (anti-drug antibodies), biomarkers or biosimilars.

Prolytic is able to extract a wide range of substances from biological matrices and determine their properties using different analytical systems.

Prolytic can use cGLP ELISA techniques to quantify large molecules, such as proteins and antibodies, as well as a range of smaller molecules, such as hormones or toxins.

ADA testing

Even more challenging is the determination of anti drug antibodies (ADAs) that may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors.

ADAs have been observed in preclinical and clinical studies resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against the hormone erythropoietin (EPO), Factor 8 (FVIII) protein or insulin and can be responsible for allergic reactions, or even anaphylactic shock. As a consequence, studies on ADA have become indispensible for bioengineered pharmaceuticals, including biosimilars.

Hence, the regulatory authorities have subjected ADA tests to increasing scrutiny, using immunogenicity safety studies.

Adverse immunological reactions may vary widely, depending on how the active ingredients are structured, produced and applied. For example, the expression of anti-Fc antibodies, anti-idiotypic antibodies or antibodies against glycosylated antigens may appear.

The detection and characterization assays for ADA must therefore be developed, customized and optimized for each drug.

A complete ADA determination entails the following steps:

• • Screening assay (“bridging“, direct or competitive ELISA, cytokine profile)
  • Confirmation assay (determination of specificity)
  • Characterization assay (=titer assay; class/isotypes of antibodies, neutralizing yes/no)

If the pharmacokinetics (PK) of the active ingredients are also available, possible changes in the PK may be correlated with the effects induced by ADA.

Prolytic offers the complete development, implementation, and optimization of ADA assays in compliance to GLP guidelines.

cGLP ELISA testing

ELISA tests performed under GLP must validate the ELISA method according to the European Medicines Agency (EMA) Guidelines on bioanalytical method validation for ligand binding assays to provide clients with reproducible and reliable results for their toxicokinetic, pre-clinical or clinical studies.

The enzyme-linked immunosorbent assay (ELISA) test uses antibodies and color change to identify a substance. Antigens from the sample are attached to a surface. A further specific antibody is then applied over the surface so it can bind to the antigen. This antibody is linked to an enzyme, and, in the final step, a substance containing the enzyme’s substrate is added. The subsequent reaction produces a detectable signal, most commonly a color change in the substrate.

About Prolytic

Prolytic GmbH is a contract research organization (CRO) specializing in bioanalysis with particular expertise in specific pharmaceutical analysis under GLP and GCP, including pre-clinical, clinical and toxicokinetic studies, bioanalysis, competent advice, and absolute quality assurance.

Prolytic operates in three principal business segments, bioanalysis, pharmacokinetics and pharmaceutical analysis, providing clients with a range of sophisticated services that cover development and validation of testing procedures, methods and processes, examining complex sample mixtures as well as pre-clinical and clinical study samples. Prolytic can also conduct compartmental and non-compartmental pharmacokinetic evaluations with analysis and quantification of small molecules, proteins, antibodies & antigens, ADAs (anti-drug antibodies), biomarkers & biosimilars and determination of enzyme activity.

Prolytic was founded in December 2002 by a group of experienced scientists as a management buy-out of the Viatris KG (formerly ASTA Medica) Drug Development Center. They company’s facilities are located in Frankurt, Germany, in the heart of Germany.

Prolytic’s operations are Good Laboratory Practice (GLP) certified and the company also works in compliance with Good clinical Practice (GCP).

Resources

Click on ELISA cGLP ADA testing for more information.
Click on Prolytic GmbH to contact the company directly.

Supplier Information
Supplier: Prolytic GmbH
Address: Alt Fechenheim 34, D-60437 Frankfurt am Main, Germany
Tel: +49 (0)69 4109 2534
Fax: +49 (0)69 4269 4784
Website: www.prolytic.de