Assay Development
ADA Assay Considerations: Rely on Sword Bio’s Unparalleled Expertise
The Positive Control (PC) reagent is pivotal when embarking on a new anti-drug antibody (ADA) assay. Regulatory agencies typically favor polyclonal PCs because they represent the in vivo immunological response. While they have accepted monoclonal PCs, they often inquire about the rationale behind this choice. For straightforward biotherapeutics, a simple explanation suffices. However, as the complexity…
ADA Assays Screening Viral Vectors For Gene Therapy
By integrating modified or new genes into the cells of the human body, gene therapy has the potential to treat a wide variety of acquired and inherited diseases. Genetic therapeutics must deliver the intended genetic material to a large quantity of specific cells within the correct tissue. Properly targeting cells requires that the genetic material…
Immuno-Oncology BioA: Pre-Existing ADAs Affecting PK
When administering human monoclonal antibodies, reconstituted human proteins, and antibody drug conjugates (ADCs), anti-drug antibodies (ADAs) can form and affect the Biotherapeutic’s exposure, bioavailability, and pharmacodynamic effects. The qualities of these ADAs – such as their specificity, magnitude, timing, maturity, and affinity – can impact pharmacokinetics (PK) and pharmacodynamics (PD). Challenges Presented by ADAs in…
Understanding the Issues with ADA Assays
The biotech industry is rapidly modifying and developing biotherapeutics into complex large molecules with specificity moieties and multiple functional domains to produce a specific biological method of action. (ADC, ACC, Bi-specific antibodies, Fusion proteins, recombinant-modified proteins, etc.) Therefore, developing LBA assays to detect the immunogenicity of these biotherapeutics is becoming very complex due to this…