• Less Volume | 10μL of sample per well
  
  
• Precise Technology | Inter and intra assay CV in accordance with FDA & EMEA requirements
  
  
• High Quality | Manufactured in Europe under ISO 13485 quality systems
  
  
• Validated | Validation, verification and lot release performed according to best-in-class scientific guidelines

• Quantitative | Measure the worlds leading therapeutic antibodies & biosimilars
  
  
• Screening | Qualitative, quantitative & free/total kits enabling full screening of deleterious Anti-Drug Antibodies (ADAs)
  
  
• Fast | Results in as little as 55 minutes for some kits
  
  
• Convinient | All kits shipped at room temperature

Therapeutic drug monitoring (TDM) is routinely implemented in inflammatory diseases to improve outcome and reduce treatment costs. TDM provides a means to test the pharmacokinetic (PK) and pharmacodynamic (PD) properties of a drug, providing more robust results in patient monitoring and experimental designs.

TDM increases efficacy of response, decreases chance of toxicity and immunogenicity. It also allows for the detection of anti-drug antibodies (ADAs) that can occur with the use of biological therapeutics and hinder drug efficacy.

Therapeutic antibodies can produce an immune response which leads to the production of anti-drug antibodies (ADA). Most ADA responses to therapeutic monoclonal antibodies (mAbs) are directed against the antigen-binding site of the biologic, and hence are neutralizing. This anti-drug antibody response explains why even fully human antibodies can still be highly immunogenic.

Anti-drug antibodies cause undesired immunogenicity, which can reduce the therapeutic effects of the biologic treatment. ADAs can also result in unwanted adverse effects in some cases. Detecting and monitoring the level of anti-drug antibodies can be of high importance when assessing adverse drug reactions.

A biosimilar is a biologic product with highly similar quality, safety and efficacy characteristics to an already approved biotechnological product (reference product). There are no clinically meaningful differences between the biosimilar and the reference biologic in terms of these product standards. Today, as data exclusivity periods of first wave biologics approach expiration/have expired, several biosimilar products are being developed or have already been approved for human use.

Biosimilars are structurally complex proteins that are typically manufactured using genetically engineered animal, bacterial or plant cell culture systems. As a consequence of this molecular complexity and the proprietary nature of the manufacturing process, which will inevitably result in the use of different host cell lines and expression systems as well as related differences in manufacturing conditions, it is not possible to manufacture exact copies of a reference biologic.