Articles in this Issue
For many years pharmaceutical companies have relied upon chemical methods to inactivate microorganisms and viruses present in their
facilities. Over these same years we have found issues with the various
chemicals used...
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Advanced therapy medicinal products (ATMPs), as they’re called in the European Union and the UK, or cell and gene therapy products (CGTPs) as they are called in the US, have long been considered game changers for the ...
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One of the most common pharmaceutical dosage forms in drug delivery is the tablet; they’re a favorable dosage form for several reasons: dosing accuracy, physical and chemical stability, competitive production costs, high...
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Taking a new biologic therapeutic from a research bench to the market is a cumbersome process. Like small molecule drugs, biologics must be approved by the U.S. Food and Drug Administration (FDA); but, because they are ...
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Parenteral drugs or products are sterile preparations containing active pharmaceutical ingredients and excipients intended to be administered by injection, infusion, implantation or by any route aside from the alimentary...
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Today’s mammalian cell culture monitoring strategies are complex and highly variable, and yet only a handful of key parameters, such as temperature, pH, and dissolved oxygen (DO), are controlled in real-time. Measurement...
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Introducing a new drug candidate to market is a complex and time-intensive process that can cost pharmaceutical companies $1 billion and more than a decade of research and development. Coupled with the fact that only ...
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Advanced therapy medicinal products (ATMPs) also referred to as Cell and Gene Therapy products (CGT) are a new class of drugs which is fundamentally different from traditional drugs like therapeutic antibodies or small ...
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Take a minute to look outside. Hopefully you see some trees, grass, and dead leaves in the fall. What you likely don’t see but is everywhere as well are fungi and yeast on the plants and in the soil. This all drains into...
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Successful drug discovery often involves protein studies, because most drugs are designed either to interact with specific target proteins, or to alter target protein-protein interactions. Current approaches toward a ...
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COVID-19 vaccines have been developed in response to the worldwide pandemic at an incredible rate. By November 9, 2021, 7.3 billion COVID-19 vaccine doses had been delivered worldwide, with approx. 30.3 million doses ...
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There are key eligibility criteria to consider when preparing an EU orphan drug designation (ODD) application (different to that of the US); one of which is justifying the “significant benefit” of ones’ product over ...
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Bacterial Endotoxin Testing (BET) is a fundamental requirement in the biomedical and pharmaceutical industries to ensure patient safety. However, both sample types and assays can be highly variable, making automation a ...
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Contec. Inc. is an experienced global leader in wipers, mops, and disinfectants for the pharmaceutical industry. Contec focuses on providing the industry with the highest quality products to meet challenging ...
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Biopharmaceutical companies obtain research and development expertise to progress pipeline development projects. While these companies also have internal manufacturing expertise, it is often not to the scale of contract ...
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A peptide is simply a short chain of amino acids, connected by peptide bonds (a type of covalent bond formed between a carboxyl group on one side and an amine on the other). A monoclonal antibody is a large protein ...
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The bacterial endotoxins test (BET) is a critical quality control release test, which means that life changing products cannot be released to the public for use until they pass this test. For the past 30 years, the ...
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Historically, the term rotation was applied to alternating the type of daily disinfectant selected. The thought was that microbes could adapt to one disinfectant chemistry and the disinfectant would no longer remain ...
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The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in August–September 2021.
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“Life should not be a journey to the grave with the intention of arriving safely in a pretty and well-preserved body, but rather to skid in broadside in a cloud of smoke, thoroughly used up, totally worn out, and loudly ...
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