The issue of immunogenicity is known to have a detrimental effect on both the efficacy and safety of a biopharmaceutical but is often not considered until clinical trials. To address this issue, Lonza has developed a comprehensive set of preclinical safety and immunogenicity risk assessment tools to aid lead selection and characterization.
Lonza’s toolbox includes the Epibase® In Silico immunoprofiling services and a suite of in vitro cellular assays, which compare the immunogenicity risk potential of biotherapeutic proteins based on their T cell epitope content. Lonza’s Dr. Noel Smith, Senior Group Leader of Applied Protein Services, recently sat down to answer commonly asked questions about the Epibase® tools.
Lonza’s Epibase® In Vitro (IV) platform uses human peripheral blood mononuclear cells (PBMCs) to provide researchers with an immune response that closely resembles the response in a human. The Epibase IV assays provide fast, cost-effective ways to gain human-based immunogenicity information on candidates prior to the first human dose.
Remarkable advances in genomics technologies bring the promise of extraordinary changes in healthcare — and some of those changes are arriving now. What’s unfolding are nine trends that we think will shape the life science markets in this accelerating genomics revolution. First, some background on how we got here.
The unique targeting capabilities and promising clinical trial results of antibody-drug conjugates (ADCs) have made them an exciting and promising treatment in the fight against cancer. According to recent analysis, experts anticipate the ADC market to be worth $10 billion annually by 2025. However, despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Below are five key areas where pharmaceutical manufacturers may face the biggest uphill battles.
Agilent Technologies Inc. recently launched a comprehensive offering of pooled CRISPR libraries for functional genomics. SureGuide harnesses Agilent’s industry-leading oligonucleotide synthesis platform to create CRISPR guide libraries, which are a critical component of the CRISPR/Cas genome editing system