Articles in this Issue
Artificial intelligence continues to become a bigger part of our daily life, but as its development and influence grow, so do concerns about how it should be regulated. The FDA has traditionally reviewed chemical molecules or ...
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Aseptic process simulation (APS, AKA Media Fill) is a critical microbiological test carried out to assess the performance of an aseptic manufacturing procedure by replacing the pharmaceutical product with a sterile culture media. ...
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Quality Control of medicinal products is a fundamental aspect for assuring the quality, efficacy and safety of the product. Testing of the product at intermediate manufacturing stages, such as testing of Drug Substance (DS), and ...
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Mycoplasma contamination is a widespread and reoccurring problem in many cell and tissue culture systems that are designed to produce biologics such as recombinant proteins, monoclonal antibodies and cell therapeutics. These ...
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The shift in the endotoxin reagent industry away from reagents sourced from the horseshoe crab towards reagents produced using recombinant technology has been occurring along a rapid and, most probably, inescapable trajectory. ...
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Dissolution testing is required by the United State Pharmacopeia (USP) to ensure that the drug products meet the established standards of strength, quality and stability. A manufacturing process is considered to be in compliance ...
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Small molecule discovery is the first of several bottlenecks in a drug development program, which typically lasts about 12 years and costs upward of $2.6 billion. The goal of discovery is therefore “to deliver one or more clinical...
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The safe and effective introduction of a transgene into a cell to cure or reduce disease severity is one of the key challenges facing the fi eld of gene therapy. Viral vectors have proven to be one of the most efficient means to ...
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The COVID-19 pandemic highlighted the scale of the risk of breaks in medicines supply, causing regulators to issue new manufacturer/MAH recommendations. One change in the EU is the transition to the more streamlined ICH Q12 PACMP ...
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The pharmaceutical industry is one of the world’s most heavily regulated industries, and the traditional document-centric approach poses challenges in terms of efficiency, collaboration, and compliance. Regulatory frameworks, ...
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While sustainability has been the banner under which many topics have been debated, its focus here is on decreasing the ongoing negative environmental impacts of drug-delivery combination products without increasing patient risk. ...
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Throughout the drug development and manufacturing processes, the potential for bacterial and fungal contamination of raw materials, production facilities, and branded products poses a serious threat to drug efficacy and patient ...
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Recent advances in genetic engineering have given clinicians a more holistic understanding of normal and pathological metabolic processes. Bio/Pharmaceutical companies have capitalized on this knowledge to develop a wide variety ...
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Angshuman Pal, Senior Scientist, Research & Development, SGS North America, Inc.: Nanoscale drug delivery systems are at the forefront of innovation, where materials in nanoscale range are employed to deliver therapeutic agents to...
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Biologics are changing the way we treat disease, affecting where companies invest, and, most importantly, impacting patients’ lives. Last year, nearly half of the 37 new drugs approved by the U.S. Center for Drug Evaluation and ...
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Although it is a ubiquitous biological molecule, mRNA is notoriously unstable. As we continue to innovate and explore the possibilities of using mRNA in next-generation vaccines and therapeutics, a key consideration requires ...
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Data plays a critical role in the discovery, development, and sustained delivery of new and existing medicines to patients. There are a variety of scientific, regulatory, project, clinical, and supply chain-related decisions ...
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The rise of hybrid work, industry consolidation and fierce competition for talent are forcing life sciences companies to rethink the purpose of their legacy facilities. Classic campuses are being reborn as innovation parks, ...
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Vitamin C (ascorbic acid) is a popular supplement available over the counter in dosage forms such as tablets, capsules, sprinkles and gummies. From a formulator’s perspective, it can be challenging since it is poorly compressible ...
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In the evolving field of pharmaceutical development, the implementation of Process Analytical Technology (PAT) for manufacturing is an essential competitive advantage. PAT offers widely accepted methods to safeguard quality ...
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Dr. Christian K. Schneider, Head of Biopharma Excellence, distils some practical takeaways from a recent panel debate about how those at the forefront of gene therapy development are overcoming the lesser-known barriers when ...
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The EU Rules for Manufacture of Medicinal Products GMP, published in 1989, contained an annex on the manufacture of sterile medicinal products to ensure the sterility of medicinal products. A version of this annex, “Annex 1”, ...
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Aseptic manufacturing is changing. Regulations like the EU GMP Annex 1 encourage modernization. Technologies such as gloveless isolators and single-use systems that automate processes and limit human interventions are becoming 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 June-July, 2023.
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Fall is usually a good time for tradeshows and conferences. And, after nearly three years of not attending any events due to COVID, I’m back at many of the shows.
It’s actually good to be back, it helps to see the people in the ...
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