Manufacturing of biopharmaceuticals is a large commitment to the public health and helps save the lives of millions of people. The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.
Biologic drugs have great promise, but they are complex and, as a result, are very expensive to manufacture and subject to technical pitfalls.
The last 12 months have brought about sought-after breakthroughs in the treatment of underserved progressive multiple sclerosis (MS) patients, and a landmark approval for one new therapy — Genentech’s Ocrevus (ocrelizumab) — may come in March 2017. In Part 1 of this two-part article, we will explore the landscape that Ocrevus will enter and the factors that will influence its uptake in progressive MS.
Donald Trump’s advance team will soon be headed to FDA’s White Oak campus to observe and learn about the agency, to help facilitate the transition from the Obama administration to the Trump administration. In this article, I describe what I expect the nascent 2017 agenda will be as Trump’s team walks in the door, and I offer a few thoughts as to why the Trump team would do well to consider the unique nature of FDA as transition planning takes shape.
Design space is a scientific concept used in the pharmaceutical/biopharmaceutical industry to support and assure product quality. The culmination of the information and knowledge gained during product development provides the foundation for the design space.
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.
Despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Here are key areas where pharma manufacturers face the biggest uphill battles.
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