Articles in this Issue
Mike Auerbach
Let’s talk vaccines for a minute.
Everyone else is these days – right?
So, let’s take a quick walk-through recent vaccine history – looking at
the disease, when the vaccine was introduced, and the vaccine’s eff ect
on humans.
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Barry Buckland, Ruben G. Carbonell, Christopher J. Roberts, Kelvin H. Lee
The unique beneficial role that vaccines play in improving human health globally is well established. The World Health Organization (WHO) estimates that 2-3 million lives are saved each year by the use of vaccines. In a little ...
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Tim Sandle, PhD
The application of single-use, sterile and disposable technology is encouraged by regulators, as the draft to EU GMP Annex 1 indicates. Such technology can increase the level of sterility assurance and reduce the environmental ...
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Azheruddin Mohammed, Ryan Gosselin, Antoine Cournoyer, MSc, MBA
Aesthetic appearance is a Critical Quality Attribute (CQA) of a freeze- dried drug product and plays a key role in its release to the consumer. A collapsed cake may be a result of poorly designed process conditions or a change in ...
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Matt Demers
Abstract
Pharmaceutical manufacturing continues to expand the use of Raman spectroscopy and is especially useful in CHO cell-based processes such as mAb production. By developing models, Raman can be used to measure and ...
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Dave Kremer
SUEZ’s Water Technologies & Solutions is an established leader providing water technology and process expertise across industries worldwide, including the life sciences. We believe that when our
customers win, we win. With ...
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Sydney Jannetta
Validation. This one word can invoke a series of feelings in any lab. It might invoke a feeling of fear or uneasiness because the process can be time-consuming and overwhelming. Or it can invoke a feeling of excitement because ...
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David Wadsworth
Microfluidic automation is the simplest form of automation available to the market today. It simplifies endotoxin testing in a platform that is extremely easy to set up, use, and maintain. With microfluidic automation comes high ...
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Ernie Hillier
COVID-19 has changed the world like nothing most of us have ever experienced in our lifetime. The world is dealing with a greater number of critical raw materials and drug shortages.
Looking back at the FDA Science Board Meeting ...
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Immacolata Porreca, PhD
Last December, Vertex Pharmaceuticals and CRISPR Therapeutics shared initial clinical trial data from studies on CTX001, a cell-based therapy for sickle cell disease and beta-thalassemia. These diseases are characterized by ...
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The continuous manufacturing of pharmaceutical compounds and fine chemicals is in high interest for the industry due to significant technical, quality, and economical advantages. Beside the more efficient, safer, and greener ...
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María A. Fontalvo-Lascano, Mayra I. Méndez-Piñero, Ph.D., Rodolfo J. Romañach, PhD, Bárbara B. Alvarado-Hernández, PhD, Nashaly Valentín Román, Rafael Méndez Román, PhD, Moraima De Hoyos Ruperto, PhD
Introduction
Process Analytical Technology (PAT) is often seen as an approach that provides valuable process knowledge during the development of a new product contributing to its approval. However, PAT may also be started by ...
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Thomas Krol, PharmD, CLP, James West, MS, Joy Hayden, BS, Mei He, Ph.D.
Exosomes are small membrane sacs or vesicles produced by cells. From a pharmaceutical scientist view, exosomes are endogenous lipid nanoparticles (LNPs). They are produced by all eukaryotic cells, surrounded by a bilayer lipid ...
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An altered metabolism often points to a disease, so it is pivotal to understand the mechanisms controlling endogenous metabolites. This need has given rise to metabolomics, the comprehensive study of the small molecule metabolites...
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The ICDD had its beginnings 80 years ago as part of ASTM, and MDI was founded over 30 years ago by Quintin Johnson who was a scientist and division leader at Lawrence Livermore National Laboratory. Both ICDD and MDI have a proud ...
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Jake McAndrew, MSc, Greg Kauffman
Excessive headspace foaming within mammalian bioreactor systems can become highly problematic for upstream bioprocesses. Consequences of foam accumulation can result in decreased cell culture growth, decreased culture ...
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SUEZ—Water Technologies & Solutions offers water technology and process expertise and provides a suite of solutions for testing quality in the pharmaceutical industry through its Sievers product line. From total organic carbon and...
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Neelam Sharma, M.S., Hemant N. Joshi, Ph.D., MBA
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Offi ce in January-February, 2021.
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