FDA warning letters highlight data integrity issues
Recent FDA Warning Letters have identified three manufacturers whose facilities held data integrity violations related to microbiology and environmental monitoring.
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Recent FDA Warning Letters have identified three manufacturers whose facilities held data integrity violations related to microbiology and environmental monitoring.
An inlet conveyor with a linear diffuser inside a continuous tablet coater offers better air flow distribution for tablet drying, research by IMA Pharma suggests.
12 March 2024 | By Actylis
Join us as we look at how the outsourcing of buffers is helping biopharma drug manufacturers to streamline their processes.
EPR Issue 1 includes articles on separation & purification, process analytical technology and drug delivery. Register your details now to download this exclusive content.
The Cabenuva (cabotegravir + rilpivirine) injectable regime could benefit individuals with HIV who have challenges adhering to treatment, Phase III interim analysis suggests.
The global pharmaceutical suspensions market is set to value $83.8 billion by 2032, due to the systems having key benefits such as supporting patient compliance.
Here, Chief Technical Officer, Mike Frodsham and Ryan Wilson, Head of Microbiome Services at SGS Quay Pharma, explore the chemistry, manufacturing, and control (CMC) challenges of developing drug products containing live anaerobic bacterial strains, used for treatments such as microbiome therapeutics.
The drug formulation study offers promise for treating different respiratory tract infections using a single antimicrobial agent, a paper reports.
The rising demand for biopharmaceuticals and a greater focus on cross-contamination are two of the biggest factors expected to impact the extractable and leachable (E&L) testing services market between 2023 and 2030, research predicts.
16 January 2024 | By
The subcutaneous injection of the novel cancer immunotherapy Tecentriq® (atezolizumab) could provide a quicker alternative to intravenous infusion, research shows.
Data from the Phase I trial showed that the cancer vaccine offered an 86 percent reduction in the risk of relapse or death in pancreatic and colorectal cancers.
Newron Pharmaceuticals and Lyndra Therapeutics’ have announced positive data from key clinical trials in schizophrenia and schizoaffective disorder.
4 January 2024 | By bioMérieux
Watch this webinar on demand to learn how InDevR and their VaxArray multiplexed immunoassay platform empower Critical Quality Attribute (CQA) testing for multivalent mRNA vaccines.
In this interview from CPHI Barcelona, Julien Lamps from Lonza CHI discusses trends shaping capsule development.
Bruce Roser of Stablepharma gives an overview of efforts to develop thermostable vaccines. Could ‘fridge-free’ formulations improve the cost-effectiveness and accessibility of vaccination?