Articles in this Issue
My initial exposure to sterile product manufacturing was back in 1973 when I first observed the aseptic filling of small volume parenterals. The image is one the reader is likely quite familiar with: aseptically garbed operators ...
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Bioconjugate therapeutics, which unite biological principles with synthetic chemistry approaches to create powerful drugs, are among the most promising modalities in biopharma. The field encompasses an assortment of therapeutic ...
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Since the first monoclonal antibody (mAb) drug was approved in 1986, more than 100 different mAbs have been approved by the U.S. FDA (Food and Drug Administration) and EMA (European Medicines Agency). During this period, ...
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In recent years the word “science” has been used more often by more people than at any other time of our lives. We and those reading this work in a technical field require (or at least should require) fluency in the language of ...
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Robert Dream
Quality by Design (QbD) is a concept first developed by the quality pioneer Joseph M. Juran. Juran believed that quality should be designed into a product and that most quality crises and problems
relate to how a product was ...
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Transferring equipment into and out of cleanrooms and critical zones has proven to be one of the greatest sources of contamination in the manufacture of sterile pharmaceuticals. To minimize the potential for adverse effects on ...
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In recent years, regulatory focus has notably shifted from sensitivity to accuracy, underscoring a pivotal change in how we approach toxicological assessments. While sensitivity remains a critical requirement, our advancing ...
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The drug development landscape has undergone a massive transformation in recent years, driven by advancements in bioprocessing and the rise of biologics. Compared to traditional small-molecule drugs, biologics differ significantly...
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The majority of digital transformation efforts fail to achieve their long-term objectives. The biggest barriers to success are not about technology—they are about people, processes, and the way new digital systems impact existing ...
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As analytical evaluation thresholds (AETs) continue to decrease, advancements in mass spectrometry have enabled us to keep pace with these changes. We can now screen at much lower levels than before, reliably detecting and ...
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The instability of drugs constitutes a major barrier in the commercial development and manufacture of pharmaceutical products. Lyophilization, or freeze-drying technology, remains an ideal method that leads to immobilization of ...
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They measure only a few nanometers in size, and yet they are our bodies’ first defense line against intruders of all kinds: antibodies are an integral part of our immune system. Since their discovery in the 1890s, science has made...
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Samsung Biologics continues to introduce new and innovative technology platforms with high-performing solutions that enhance therapeutic efficacy and proactively address evolving industry trends.
S-AfuCHO™ is a cell line ...
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Today’s research and development (R&D) pipelines are increasingly diverse, encompassing a broad range of modalities, including antibodies, proteins and peptides, cell and gene therapies, oligonucleotide therapeutics, small ...
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SGS established the bioanalytical testing facility in Hudson, NH, as part of its strategic effort to broaden our scope of testing solutions offered in North America, as well as expand our footprint for Bioanalytical testing ...
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In the ever-evolving landscape of microbiology and quality control, Rapid Microbial Methods (RMMs) have emerged as powerful tools for detecting and enumerating microorganisms in pharmaceutical manufacturing, food and beverage ...
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A simple headache often leads to a quick fix: a single ibuprofen. But the journey of that pill from concept to consumer is anything but straightforward. Drug development is a complex, time-consuming, and costly endeavor marked by ...
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Ahead of CPHI Milan – the world’s largest pharma event where a record 62,000 attendees are expected – we spoke with Patrick Falvey, Principle Consultant from Latham BioPharma on the global trends ahead in bio manufacturing. Falvey...
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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 and July, 2024.
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I will admit that I’m a sucker for a snappy headline.
And, despite my best eff orts to resist, I have clicked on a few dubious headlines over the years. Luckily none have resulted in my back account being drained or my computer ...
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