Articles in this Issue
Nucleic acids are emerging pharmaceutical modalities to tackle the undruggable targets, with increasing product approvals within the last five years.
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This article will begin by reviewing the Guidance for Industry PAT - Framework for Innovative Pharmaceutical Development Manufacturing and Quality Assurance, written by the FDA in September 2004. It ...
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Microbial contamination during biopharmaceutical
manufacturing of intermediates or the final product carries risks not only for the patient but also for the operator and the company. It can result ...
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The implementation of Continuous Manufacturing (CM) in the pharmaceutical industry is not advancing as fast as foreseen in its initial years, when the flexibility of this technology encouraged many ...
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Cell banks represent the fundamental starting substrates for biological Drug Substance/Drug Substance intermediate (DS/DSi) manufacturing. Therefore, the availability of well-characterized cell banks ...
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In December 2021, SGS acquired Quay Pharmaceuticals Limited (Quay Pharma), a UK-based provider of innovative, formulation research
and development bringing the first Contract Development and ...
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For both sterile and non-sterile manufacturing, bioburden control as evidenced by microbial counts is especially important in relation to the quality of the finished product and as an indicator of ...
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Bio-Fluorescent Particle Counters provide superior monitoring capabilities over the traditional plate count method due to their ability to monitor continuously with no sample preparation or ...
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As you said, chromatography is ubiquitous: it’s used in many different forms and for answering numerous analytical questions in Research and Development (R&D), production, and Quality Control (QC). ...
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Recently, the European Union released a revision to the Good Manufacturing Practices (GMP) Annex 1, which provides the rules for the manufacture of sterile drug products. It took 14 years of ...
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Pharmaceutical Quality by Design (QbD) is a systematic approach to drug product development that begins with predefined objectives, and emphasizes both product and process understanding and control ...
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For years pharmaceutical waters have been released at risk due to waiting for QC results. This is because the testing of water for pharmaceutical production can be labor and time intensive, requiring ...
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Subcutaneous injection is a routine method for administering drugs, notably for biopharmaceuticals. However, it is challenging to predict how Active Pharmaceutical Ingredients (APIs) such as ...
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Defining a suitable agitation strategy is essential for the successful development of upstream mammalian bioprocesses. Such a strategy can drive oxygen mass transfer within the bioreactor system to ...
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Driving manufacturing process improvement is one of the most effective ways to increase quality, operational efficiency, and ROI (Return On Investment). Improving the processes that contribute to the ...
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The biopharmaceutical industry has seen remarkable changes in recent years. From cancer treatments, to cell and gene therapy, to the COVID-19 vaccines and other vaccines – there is no doubt the ...
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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 July-August, 2022.
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