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Growth and Advancements in Fill/Finish
Employing novel technologies and more patient-centric approaches
Delving into Biopharmaceutical Development and Manufacturing
Quality Considerations in Changing Excipient Providers
March 08, 2023
Actylis new 30,000-ft² API manufacturing facility is located in Eugene, Ore.
Sotatercept, a drug candidate acquired by Merck in an $11.5 billion acquisition, showed statistically significant improvements in various measures.
Janssen has received a positive opinion from EMA for AKEEGA plus prednisone or prednisolone for the treatment of BRCA1/2 gene-mutated metastatic castration resistant prostate cancer.
March 07, 2023
In this episode, Rhonda Henry and Adam Mendizabal from Emmes discuss the role CROs play in cell and gene therapies undergoing clinical trials at all stages.
March 06, 2023
Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.
The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.
March 03, 2023
The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.
In this episode of Drug Digest, Grant Playter, associate editor, speaks with computer validation experts on how to set data controls and why efforts spent here are financially rewarding in the long run.
The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety.
This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.