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The breakthrough approach is commonly used, but the devil is in the details.
In this article, a simple chromatographic model is proposed that is capable of predicting the impact of pH and ionic strength on HIC chromatograms.
The COVID-19 vaccines opened the door to powerful market potential for other nucleic acid-based therapies.
The innovation of going from stainless-steel bioreactors to fixed-bed bioreactors shows an evolution in upstream optimization.
Makers of specialty biologics, gene therapies, and other personalized medicines are working to identify and reduce potential supply chain risks both upstream and downstream.
FDA has spurred investment to create and develop 600 therapies.
What can we take away from Pfizer's acquisition of Seagen?
June 02, 2023
An increase in applications for gene therapies is putting stress on FDA’s resources.
Hope is on the horizon as novel solutions and improvements aimed at benefitting the drug development process with the right framework are coming to the fore.
New fields are being explored to bring novel antibody candidates to the pipeline.
Compliance with GMP standards remains an integral focus in bulk mAb manufacturing.
June 01, 2023
Scaling cell therapy production workflows requires the establishment of closed, automated steps.
Analytical characterization of biosimilars plays a crucial role in a successful path to regulatory approval.
Through the acquisition, Avacta gains Coris’ product portfolio consisting of diagnostic tests for respiratory, gastroenteric, and blood-borne pathogens as well as for the detection of antibiotic resistance markers.
WuXi Biologics is expanding its manufacturing capacity for drug substance and drug product at its sites in Leverkusen and Wuppertal, Germany.
Contract testing services demonstrate a major increase in the speed and efficiency of testing using new testing methods and technologies.
A partnership between Rentschler Biopharma and Ikarovec will support the accelerated development of novel gene therapies for the treatment of eye diseases.
Vaccine nationalism strengthens viruses and poses deadly risks for all involved.
COVID-19 has raised the specter of pandemic planning and the question of what can be done now to prevent future disaster.