Articles in this Issue

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  How the Bacterium Cronobacter sakazakii Precipitated a National Shortage of Infant Formula

  The title of this review article is somewhat incorrect, as a bacterium has no intent outside survival and passing on its genes to future generations. In contrast, decisions by manufacturers, ... read more
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  Integrating Continuous Technologies for Rapid Delivery of Cost-Effective Biotherapeutics...

  The global biopharmaceutical market is estimated to grow to $3.9B by 2024 - a CAGR of 8.59%, with the majority of the growth in monoclonal antibodies. This growth will be through larger numbers and ... read more
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  Vibrational Spectroscopy for the Analysis of Dissolved Active Pharmaceutical Ingredients

  Vibrational Spectroscopy in terms of Raman and infrared spectroscopy is a powerful toolbox for the analysis of solutions containing Active Pharmaceutical Ingredients (API). In this article, we provide... read more
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  Developing Cysteine Protease Inhibitors for Therapies Against SARS-CoV-2

  SARS-CoV-2, the virus responsible for the global COVID-19 pandemic, has caused millions of infections and more than five million deaths worldwide to date. Although the speed with which COVID-19 ... read more
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  The Evaluation of a Ready-to-Use Combination Sanitization Regimen to Support a Contamination...

  A primary tenant of aseptic manufacturing is controlling the environment microbiologically before, during, and after a manufacturing batch. The static and operational controls include the combined ... read more
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  Understanding Five Major Impacts of the Pandemic – and Future Implications for the Biopharmaceutical...

  The events of the past two years have made a profound impact on biopharmaceutical companies and every cog in the wheel of our industry. Internally, firms were forced to make radical shifts in ... read more
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  Antibody-Drug Conjugates (ADCs): Potent Cancer Killers with PK Challenges

  Antibody-Drug Conjugates (ADCs) are an evolving therapeutic modality with an unprecedented ability to target and destroy cancer cells. They were developed to improve upon conventional chemotherapies’ ... read more
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  Characterizing the Effects of Antifoam C Emulsion on Oxygen Mass Transfer within the BIOne...

  Excessive headspace foaming within mammalian bioreactor systems can become highly problematic for upstream bioprocesses. Consequences of foam accumulation can result in decreased cell culture growth, ... read more
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  Isolator Technology – From Project to Operations

  Now more than ever companies manufacturing parenteral products with aseptic filling are urged to look at barrier technologies, either Restricted Access Barrier Systems (RABS) or isolators. This ... read more
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  Advances in Recombinant Adeno-Associated Virus Production for Gene Therapy

  Recombinant Adeno-Associated Virus (rAAV) is the leading vehicle for delivery of gene products for the treatment of gene therapy. Low production yields and product quality contribute to high ... read more
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  A Discussion on Microbiology - Trends and Topics

  Rapid Microbial Methods are a great example of this development. Rapid technologies, such as Celsis® instruments, allow laboratories to detect microbial contamination in half the time compared to ... read more
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  Maintaining Data Integrity During the Migration to Real-Time Testing

  Implementing Real-Time Testing (RTT) or Real-Time Release Testing (RTRT) in pharmaceutical manufacturing is becoming a more widespread goal to improve efficiency when it comes to assuring quality ... read more
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  From Protein Powder to All Life on Earth: The Importance of Amino Acids

  What’s that ‘secret’ ingredient that makes up our protein-filled foods, powders, and bars we consume nearly every day after the gym? If you guessed amino acids, you’re spot on! Yes, amino acids are ... read more
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  Pharmaceutical P.I.N. Points - Patent Innovation News - in May/June 2022

  The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in May-June 2022. read more