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Quality by Design (QbD) precepts provide opportunities for enhancing efficiencies and reducing costs, especially for generic products. Over 80% of prescriptions dispensed in the United States in 2012 utilised generic dosage forms and it is unlikely that this proportion will increase to any extent because fewer innovative drugs are set…
Spray drying is a proven, flexible and scalable process used within the pharmaceutical industry to address a wide range of formulation and drug delivery challenges. Its versatility has been proven through applications to both small chemical and biopharmaceutical drugs for product delivery via multiple routes of administration.
19 October 2016 | By Viavi Solutions Inc.
In this webinar, experts from Viavi, Pfizer & Université Laval discussed how MicroNIR is used to optimise fluid bed drying and to reduce waste at tablet compression...
Currently, subcutaneous delivery of therapeutic proteins is a fast-growing field, especially for such established modalities as monoclonal antibodies, which require large quantities of drug to be administrated. Different approaches, including high protein concentration, speciality formulations and drug delivery matrices, as well as devices enabling a more rapid administration of larger…
From a microbiological perspective, pharmaceutical products fall into two categories – nonsterile and sterile. For both categories manufacturers must eliminate, or minimise, potential health risks to patients related to microorganisms and the toxins they produce, whilst maintaining product quality. Many contributing factors may affect the quality of a medicine or…
Researchers from the National University of Singapore have found a way to make personalised medicine cheaper and easier.
In Issue #1 2016: Regulation, Drug Delivery, Raman, PAT, Formulation, NIR, Microbiology, and much more...
22 October 2015 | By Iain Moore, President, EXCiPACT asbl
There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits…
22 October 2015 | By John Carpenter, University of Colorado / Amber Haynes, Fradkin KBI Biopharma / Christina Vessely, Biologics Consulting Group Inc.
Quantifying and sizing subvisible particles in biopharmaceutical products are crucial aspects of formulation development, stability studies, process development, product release and extended characterisation of the final drug product.
3 September 2015 | By Benjamin K. Hodnett, Anita R. Maguire, Pat J. Guiry, Ake C. Rasmuson, Brian Glennon and Abina M. Crean - SSPC
The Synthesis and Solid State Pharmaceutical Centre (SSPC), a global hub of pharmaceutical process innovation and advanced manufacturing, is funded by Science Foundation Ireland (SFI) and Industry, and represents a unique collaboration between 22 industry partners, nine research performing organisations and 12 international academic collaborators. It is a €42 million…
20 April 2015 | By Ravendra Singh, Marianthi Ierapetritou and Rohit Ramachandran: Rutgers University
Continuous pharmaceutical manufacturing together with process analytical technology (PAT) provides a suitable platform for automatic feed-forward/feed-back (FF/FB) control of the end product quality as desired by quality by design (QbD)-based efficient manufacturing. The precise control of the quality of the pharmaceutical product requires proactive, corrective actions on the process/raw material…
28 October 2014 | By Axel Becker, Scientist, Merck KGaA
Over the past decades, pharmaceutical drug development has undergone some significant changes, a prominent example for this being the emergence of biomolecular drugs (New Biological Entities, NBEs) such as antibodies and peptides. However, classical small molecule drugs (New Chemical Entities, NCEs) are far from being a dying species, and in…
5 September 2014 | By Ryan Gosselin & Nicolas Abatzoglou, Pfizer Industrial Research Chair, University of Sherbrooke / Philip Quinn, Pfizer Industrial Research Chair, University of Sherbrooke and Process Analytical Sciences Group, Pfizer Canada / Joanny Salvas & Jean-Sébastien Simard, Process Analytical Sciences Group, Pfizer Canada
Pharmaceutical product manufacturing is a conservative environment because of the obligations to abide by rigorous operation protocols aimed at insuring the highest possible product quality. A relatively recent initiativeguidance, from the U.S. FDA (Food and Drug Administration) has encouraged innovation and development of PATs (Process Analytical Technologies) for improved process…
Fraudulent misrepresentation, substitution or imitation of premium products has always been a problem for both the regulatory authorities and the pharmaceutical industry. The task of finding and preventing counterfeit products is particularly challenging1,2. Several analytical techniques are available to help characterise pharmaceutical compounds: physical profile; X-ray diffraction; infrared spectroscopy; mass…
3 July 2014 | By Brian Armstrong and Katrina Brockbank, Freeman Technology
Powders and bulk materials are widely used in industry as raw materials, intermediates and finished products. Indeed, over 60% of the value of pharmaceutical sales worldwide is accounted for by powder formulations, typically as tablet/capsule/sachet or in the form of an inhalable powder. Whilst they are used extensively, they are…
