As cell and gene therapies, RNA-based platforms, and antibody-drug conjugates accelerate toward commercialization, the pharmaceutical industry must develop analytical methods robust enough to characterize increasingly complex therapeutic modalities while remaining flexible enough to evolve with emerging science. PharmaSource asked analytical
The United States and the United Kingdom reached a pharmaceutical pricing and trade agreement that raises NICE cost-effectiveness thresholds by 25% and eliminates tariffs on medicine imports between the two countries. The UK committed to increasing NICE’s cost-effectiveness range from
“If you can’t demonstrate international quality standards, nobody is going to take a chance on a million-dollar batch to save a few dollars on their manufacturing. It just won’t happen.” Eric Langer is President of BioPlan Associates, where he has
“The world can change overnight. We have to accept volatility as part of the world we live in.” Peter DeYoung, CEO of Piramal Global Pharma, has spent 13 years with the Piramal Group, navigating the complexities of pharmaceutical manufacturing across
As clinical development timelines compress and therapeutic complexity rises, pharmaceutical sponsors must secure manufacturing partnerships that adapt to uncertainty without draining budgets. How to structure CDMO contracts that deliver both flexibility and cost efficiency has become a strategic imperative and
AstraZeneca announced plans to invest $2 billion to expand its long-standing manufacturing footprint in Maryland, including a significant expansion of its flagship biologics facility in Frederick and construction of a new state-of-the-art facility in Gaithersburg for clinical supply of molecules
“Despite the volatility, the industry is getting some positive energy and renewed confidence” Jeremie Trochu, Chief Executive Officer at Ardena, has spent two decades building and scaling businesses across the biopharma sector. He was part of the leadership team that
“Life has not become simpler and easier. It’s become more complex. Success requires acknowledging this complexity early and building flexibility into every aspect of the business model.” Renée Aguiar-Lucander is the CEO of Hansa Biopharma, appointed in April 2025. Renée
MilliporeSigma is betting on advanced chromatography capabilities to address persistent bottlenecks in antibody manufacturing as the company prepares to integrate JSR Life Sciences’ Protein A resin technology into its bioprocessing portfolio. The acquisition, announced in October 2025 with an expected
“Poland is no longer an emerging market. It’s a partnering market.” Dr. Magdalena Kulczycka, founder of the Biotech Innovation Institute, is a molecular biologist with experience spanning academia, entrepreneurship, and venture capital. Her institute fosters biotech growth from lab to
