Articles in this Issue
Consider this: an ingestible pill with an embedded sensor that transmits a digital message from within a patient’s stomach to an app on their smartphone. It’s the stuff of science fiction but may soon...
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Process validation is required, in both general and specific terms, by the cGMP regulations in parts 210 and 211, and is a legally enforceable requirement under section 501(a)(2)(B) of the Act (21 U.S...
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The pharmaceutical sector is on the brink to join the fourth industrial revolution. It also allows clinicians to develop better-performing medical equipment by providing new methods to personalize ...
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When pharmaceutical companies begin using medical devices such as pre-filled syringes, safety-systems, or auto-injectors, a common challenge is integrating new medical device procedures, required by ...
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Besides detecting and enumerating the number of microorganisms in an environmental test sample (i.e., air, compressed air, purified water and equipment surface monitoring), it is important to identify...
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In this article, members of the USP Microbiology Expert Committee discuss the initiatives being taken to address the requirement of manufacturers of gene and cell therapies in the areas of microbial ...
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Bioavailability is a key attribute of lead compounds and drug candidates. Usually only a fraction of the substance administered to a patient exerts its therapeutic effect. Much of it binds to proteins...
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Artificial Intelligence (AI) is a convergence of technologies which recapitulates four dimensions of human intelligence, i.e., sensing, thinking, acting and learning. AI is being applied to ...
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An important factor for consideration when cleanroom equipment is selected is the surface finish and surface roughness, particularly in relation to stainless steel given the commonality of this ...
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Per USP and other harmonized compendia, conductivity is an important quality metric that must be monitored for product quality and patient safety. The FDA and USP have established conductivity, total ...
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Cleaning and microbial contamination control are critical focus areas in pharmaceutical and medical device industries. Robust cleaning and disinfection programs are needed to meet the required ...
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Even before the current pandemic laser-focused the pharmaceutical industry’s attention on achieving a coronavirus vaccine, the spotlight on injectable drugs was bright thanks to the accelerating ...
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Antibody-drug conjugates (ADCs) are one of the fastest-growing drug classes in oncology. They are an effective drug delivery system that can target tumor cells by employing the specificity of an ...
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The global pharmaceutical market experienced significant growth in 2020. Accelerated by the ongoing SARS-CoV-2 pandemic, eight vaccines were approved globally with roughly 5.95 billion doses ...
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The adoption of high-throughput experimentation systems and advances in multi-omics analysis methods are generating large volumes of bioprocessing data that can support the design of next generation ...
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Conventional spectroscopy is typically based on a fixed 10 mm pathlength measurement. Due to the fixed nature of the pathlength, conventional spectrophotometers have a limited dynamic range and are ...
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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 particularly true in ...
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Development of a drug can be thought of as a passage through a series of stage gates. With each gate, there is a chance to pause and evaluate the suitability and purpose of the dose form. A design ...
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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 June-July 2021.
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Looking back, I think we had about two to three weeks in May – June where things related to the pandemic were looking up. Cases, hospitalizations, and deaths were all trending down. If you were ...
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