Biopharmaceuticals In Perspective

whitePaper | May 11, 2022

CDER is taking another step towards realizing the vision for pharmaceutical quality in the 21st century: a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.

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 | January 18, 2023

Reaching a post-pandemic era is an alluring prospect for almost everyone around the world after the disruptions of the past three years.

whitePaper | October 14, 2022

Supply constancy, cost, sterility – even a subset of the factors that impact materials selection can be daunting for biopharmaceutical companies embarking on a new drug development project.

whitePaper | July 4, 2023

The past two decades have witnessed transformative changes in our approach to using modeling & simulation to assess and manage DDIs. Multidisciplinary innovations in mechanistic assessment of absorption, distribution, metabolism, and excretion (ADME), population pharmacology and pharmacogenetics.

whitePaper | January 3, 2022

While valuations for the life sciences sector in this past year have been mixed, the underlying performance and outlook for the