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Regulatory guidelines, from the 2004 U.S. FDA PAT framework to ICH Q8, Q9, Q10 and Q11 documents, have brought a shift to pharmaceutical processes and manufacturing...
This In-Depth Focus looks at QbD and PAT for cutting biopharma attrition rates as well as continuous freeze-drying technology for biopharma products...
Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing...
Women undergoing IVF may become pregnant with fewer treatment cycles thanks to a device that uses an obstacle course to select the fastest and healthiest sperm...
Particle size reduction is a fast and cost-effective answer to increasing the exposure of poorly soluble oral drugs by increasing surface area and thereby improving dissolution rate. This approach will only work for DCS IIa1 drugs where dissolution rate is the rate-limiting factor for absorption. This may be applicable to…
Hot melt extrusion (HME), a manufacturing technique traditionally used in the plastic and food industries, is now attracting significant interest from the pharmaceutical manufacturing sector. This is primarily because HME enables the continuous manufacture of a wide variety of dosage formulations, including solid dose form, which is of particular importance…
Pharmaceutical manufacturing in the modern era is facing unprecedented demands, including in-depth scrutiny of production methodology, and inefficiencies in current practices with respect to waste, energy usage and time management. Coupling this with increased complexity in the manufacture of newer products and the decline of blockbuster drugs, results in an…
QbD and PAT could revolutionise the way biopharma industries operate by cutting down their attrition rates, which could drastically change their business model. This article considers the issues involved.
This issue celebrates European Pharmaceutical Review's 21st birthday through 21 interviews with leading lights from across the pharmaceutical industry...
In this Separations & Purifications In-Depth Focus: Sample preparation - is it possible to have too much? Discover the value of better quality chemistry; Determination of glucosamine in food supplements by HILIC-ESI-MS; Applying simple PAT tools to crystallisation in process chemistry...
Crystallisation is a common step in the synthesis of organic compounds used to isolate and purify the desired product. As the importance of crystallisation has increased and chemists improve the processes involved, process analytical technology (PAT) tools can be used to design, analyse, and control them. This article considers the…
In this issue: Sample preparation - is it possible to have too much? Developing successful over-the-counter syrup packaging for the highly regulated EU market. In-line process PAT in continous wet granulation, and much more...
Production of protein therapeutics by mammalian cells is the most widely used bioprocess because of its ability to properly produce and fold a recombinant protein...
9 May 2017 | By Syrris
Syrris is launching its revolutionary Titan system at InformEX in Philadelphia, USA, from the 16th to the 18th of October...
Measure Total Organic Carbon (TOC) using patented Membrane Conductometric Detection technology that delivers unmatched sensitivity, selectivity, stability, accuracy, and precision.
