Displaying 751–771 of 771 results for
FDA recently released its final guidance on process analytical technology, PAT A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance," as part of its broader 21st Century cGMP initiative.
This paper provides an overview of the continuous processing landscape from dealing with FDA to the intricacies of continuous chemical reactions. The authors, from Pfizer Inc.s Pharmaceutical Sciences division, say the industry will change dramatically in the next decade.
Many companies today are focusing on reducing energy costs to lower overall manufacturing costs. However, they often overlook compressed air, which can have a significant impact on electricity costs. This paper quantifies the cost of compressed air leaks and illustrates how the efector Metris ...
Traceability weighing and dispensing optimization systems represent a comprehensive solution to reduce drug manufacturing costs, increase productivity and efficiency, improve time-to-market and drive regulatory compliance.
FDA's final report on Pharmaceutical cGMPs for the 21st Century a Risk-Based Approach is hot off the press. From aseptic processing to electronic record-keeping to quality systems, get your guidance here.
Capacitance-type magnetic flowmeters have traditionally offered the advantage of having non-wetted electrodes and the ability to measure low conductivity fluids. However, they suffered from a sensitivity to flow noise and zero instability. Innovative technology overcomes these limitations and ...
This article, excerpted from Cambridge Health Institutes CHA Life Science Report, discusses the tremendous growth expected for monoclonal antibodies, and how manufacturers are improving the quality of MAb-based products.
Crystallization processes pose challenges to manufacturers who seek to apply process analytical technologies (PAT), but progress is being made. This paper, from FDA's Center for Drug Evaluation and Research, discusses the challenges and provides some examples of how they're being addressed.