Pharmacogenomics Testing: Harnessing the Power of Genetic Data for Personalized Medicine

whitePaper | February 24, 2023

A new way of thinking and working has evolved for the discovery of therapeutic antibodies. Until recently, large numbers of antibodies were generated, only for a relatively small fraction to be sampled and engineered for further lead generation.

whitePaper | May 25, 2023

CDER’s mission is to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients. To advance this mission, FDA’s Pharmaceutical Quality for the 21st Century Initiative promotes an efficient, agile, and flexible pharmaceutical manufacturing sector that reliably produces quality drugs without excessive regulatory oversight.

whitePaper | May 22, 2021

One of the key roles of the generic and biosimilar medicines industry is specifically to promote the widest possible access to affordable medicines with high quality, safety, and efficacy for patients globally by introducing competition into the markets. Despite the many hurdles, the generic medicines companies have clearly lived up to the challenges posed by the pandemic as it is an industry that is quick to adapt and agile in manufacturing scale-up. During the outbreak of COVID-19, this industry was providing most of the medicines needed in Intensive Care Units to ventilate critically ill COVID patients. It is also providing most of the quality medicines dispensed around the world, especially for increasingly prevalent chronic diseases and is therefore a strong contributor to health outcomes globally.

whitePaper | February 16, 2023

Flexible and cost-effective, single-use technologies offer biopharmaceutical companies a way to transform their biologics production and meet the growing demand for these life-changing therapies.

whitePaper | January 20, 2023

Understanding an antibody’s mechanism of action (MOA) is critical to its clinical success. Not only does MOA have a large impact on safety and efficacy.

whitePaper | June 27, 2022

Following on from our review of trends in the current pharmaceutical R&D pipeline this supplement takes a look at the industry’s success stories of 2021