A new survey from Unispace Life Sciences finds 57% of senior executives see the adoption of intelligent systems as critical to the next generation of laboratory environments.
Out of 202 Complete Response Letters issued between 2020 and 2024, 150 involved quality/manufacturing issues, according to the regulator’s newly released documents.
Drug manufacturers have been left in a climate of anxious anticipation and a heightened state of uncertainty as the pharma industry waits to see if the president is bluffing.
Generics, which make up approximately 90% of prescription volume in the U.S., are produced primarily in India as Hikma looks to onshore production of these critical drugs.
The tariffs on pharmaceuticals would have a grace period of up to a year and a half to give drugmakers the opportunity to move their manufacturing operations to the U.S.
After touring the Fishers facility, William Blair analysts say demand for syringes is “healthy and robust” with a sequential utilization ramp-up expected in coming quarters.
Alessandro Maselli, who took the helm in 2022, has navigated the global CDMO through the COVID-19 pandemic and the landmark $16.5 billion acquisition by Novo Holdings.
In the pharmaceutical, biotech, and life sciences industries, the terms validation and commissioning are frequently — and mistakenly — used interchangeably.
While jobs dropped 3.7% last year, the state is still home to the largest number of manufacturing-related life science jobs in the U.S., according to Biocom California.
Pharmaceutical manufacturers often accept avoidable limitations of ULT freezers, such as temperature fluctuations, large footprints, and reactive maintenance. They should be demanding...
The strategic realignment is aimed at better serving customers across the drug development lifecycle, from research and discovery to clinical and commercial manufacturing.
Smart manufacturing is “nearly universal” with 95% of manufacturers saying they are using or evaluating smart technology, according to a new survey from Rockwell Automation.
The CDMO completed site construction and infrastructure installation at its 50,000-square-foot facility, with full-scale GMP production slated for this summer.
While the process has been a buzzword for years, offering an alternative to traditional batch manufacturing, industry uptake has been slow. However, the tide may be turning.
U.S. Pharmacopeia CEO Ronald Piervincenzi told lawmakers that advanced manufacturing technologies will better enable production of pharmaceuticals and pharma ingredients.
The Tar Heel State’s decades-long focus on economic development in life sciences and pharma manufacturing is bearing fruit, as it looks to rival the Bay Area and Boston.
Part of Danaher Corporation, Cytiva’s strategic investment in Asia-Pacific, Europe, and the United States aligns with its long-term growth plan to better serve customers.
While Big Pharma companies have announced $270 billion in domestic investments, lab leasing declined significantly in Q1 2025, finds JLL’s U.S. Life Sciences Property Report.
Equipped with high-speed lines, robotics, and automated systems, the site started commercial production at the end of 2024 after completing construction in only two years.
The CDMO is building identical large-scale production facilities in the U.S. and Denmark, designed to modularly and seamlessly integrate manufacturing regardless of location.
The company is expanding the site’s sterile fill-finish capabilities while sunsetting traditional batch, solid dose production and adopting continuous manufacturing.
Despite the potential threat of tariffs, trade policy did not factor into the India-based CRDMO’s purchase of a Baltimore biologics site from Emergent BioSolutions.
More than 300 comments have been posted in response to a Department of Commerce investigation into the importation of certain pharmaceuticals and pharma ingredients.
CEO Padraig McDonnell contends that Biovectra’s capabilities are in the “sweet spot” of GLP-1s and complex chemistries, with strong medium- and long-term growth potential.
