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The evolution of therapeutic modalities drives the adoption of single-use technologies.
Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
May 09, 2025
Poor API quality may often lead to delays in production and a shortage of supply.
May 08, 2025
The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how geopolitical instability in Europe, and beyond, has impacted the bio/pharmaceutical supply chain.
May 07, 2025
This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Amit Chivate, senior market manager, Greater Asia and China, Roquette, provides his perspective on FDA’s recommendations regarding nitrosamines.
The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about high-concentration biologics and some of the biggest challenges associated with their formulation.
The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about how technological advances will impact the biopharma industry in the future.
BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.
May 06, 2025
Incorporating sustainable practices into process designs as early as possible ensures optimal performance.
The shift toward personalized medicines poses new challenges in cleanroom protocols.