Articles in this Issue
Long acting injectables (LAIs) are drug products, intended for administration through the parenteral route and designed to release Active Pharmaceutical Ingredients (APIs) in a ...
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When the FDA conducts inspections of aseptic drug manufacturers, they cover systems and areas within systems that present the greatest risk of product contamination and require ...
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New tools are urgently needed to control the current out-of-control COVID-19 pandemic which can be further complicated by annually emerging influenza infections, especially in the ...
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Self-emulsifying drug delivery systems (SEDDS) help solubilize poorly soluble drugs in the dosage form and more importantly facilitate drug dispersion and dissolution in vivo ...
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Event-related sterility assurance is, simply put, any event that compromises the integrity of the barrier enclosing the sterilized material. Such events may occur just subsequent ...
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In the biopharmaceutical industry, quality is pivotal. For a final product to meet quality standards, quality must be built into the production process. Biopharmaceuticals, however...
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They say “A rising tide lifts all boats” and this is true for advances in automation as applied to various analytical test methods. Have you checked the state of automation ...
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New technologies and innovative thinking are profoundly changing the biopharmaceutical drug production industry holistically, giving rise to “the factory of the future.”
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Since the release of the latest FDA guidance documents on 21 CFR part 11 and data integrity, there has been much confusion regarding what is required for compliance. This is ...
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In 2004 the FDA published a guidance document on Process Analytical Technology (PAT). It contains non-binding recommendations and serves to encourage GMP manufacturers to deploy ...
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Mycoplasmas are commensal parasites that can be contaminants of cell cultures and animal-derived products. These contaminants are not as visually obvious during culture of cells as...
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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 December 2021 – January 2022.
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Patient centricity seems to be one of the more popular phrases buzzing around the healthcare industry – and with good reason.
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