Immunogenicity Of Biological Drugs: Why, How And What

Why Should You Attend:

The consequences of an immune response to biological drugs, range from transient appearance of antibodies without any clinical significance to severe life-threatening conditions. To develop efficacious and therapeutic biologicals, one need to investigate the immunogenicity of these drugs, i.e. their ability to induce the generation of anti-drug antibodies, that might abrogate the efficacy of these drugs and, in a worst case situation, might be very harmful to the patients. For this reason, Regulatory Agencies all over the world requires drug developers to have immunogenicity plan that include mitigation steps in the event of the development of anti-drug antibodies.

Scientists involved in developing such drugs, need to be cognizant of the biochemical characteristics of their drugs and their immunogenicity potential. Moreover, they need to know how to test for the generation of an immune response and plan mitigation steps if need be.

In this webinar, we will discuss the ability of a biologicals to induce the generation of an immune response against the drug itself (immunogenicity potential) and the consequences of such response. To be able to detect the immunogenicity potential of a drug, we will discuss the need to develop assays that can specifically and reliably measure the immune response. Additionally, we will discuss the different methods used_and their caveats_to predict, a priori, the immunogenicity potential of biologicals.

Areas Covered in the Webinar:

In this webinar, we will discuss:

• The consequences of an immune response to a biological drug,
• Immune responses and the parameters that contribute to the generation an immune response to a biological,
• Intrinsic parameters and how to mitigate these,
• Extrinsic parameters and how to mitigate them.
• how to detect an immune response to biological drug,
• the different assays needed to screen for and measure an immune response.
• How to characterize this response
• and can we predict, a priori, the immunogenicity potential (ability to induce a response) of a biological drug,
• Exvivo, insilico, invivo and others
• The caveats of each of these methods

Who Will Benefit:

• Preclinical development scientists such as Bioanalytical scientist and toxicologists
• Research and development scientists developing drugs
• Manufacturing scientists

From

• Biotech and pharmaceutical industries

Free Materials:

• Reference documents
• Rule documents or guidance
• Checklist
• SOP template
• Easy fill in forms
• Articles

Michel Awwad
Preclinical Development, Indivisual

Scientist with more than 20 years of experience in small biotechnology and large pharmaceutical companies. Developed protein-based (peptides, mAb, ADC, bispecific antibodies), small molecules and liposomal products. Carried these products from inception through preclinical development into early clinical development. Developed products for the treatment and diagnosis of cancer, for the treatment of immunological diseases, including those that can facilitate transplantation of solid organs, and for neurological dieses (Alzheimer’s). Directed the safety as well as bioanalytical studies (PK and Immunogenicity) of many of the products in the preclinical setting. wrote Preclinical sections of regulatory submissions.

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