Articles in this Issue

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  Changing the Methods Used for Inactivation of Microorganisms and Viruses

  For many years pharmaceutical companies have relied upon chemical methods to inactivate microorganisms and viruses present in their facilities. Over these same years we have found issues with the various chemicals used... read more
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  Five Strategies for Success in Bringing Novel Therapies to Market

  Advanced therapy medicinal products (ATMPs), as they’re called in the European Union and the UK, or cell and gene therapy products (CGTPs) as they are called in the US, have long been considered game changers for the ... read more
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  Leveraging Direct Compression Technology to Improve Tableting Efficiency

  One of the most common pharmaceutical dosage forms in drug delivery is the tablet; they’re a favorable dosage form for several reasons: dosing accuracy, physical and chemical stability, competitive production costs, high... read more
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  Key CMC Considerations for Biologic Development

  Taking a new biologic therapeutic from a research bench to the market is a cumbersome process. Like small molecule drugs, biologics must be approved by the U.S. Food and Drug Administration (FDA); but, because they are ... read more
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  Formulation and Lyophilization Process Development for Endotoxin Kits

  Parenteral drugs or products are sterile preparations containing active pharmaceutical ingredients and excipients intended to be administered by injection, infusion, implantation or by any route aside from the alimentary... read more
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  In-Line Real-Time Monitoring of CHO Cell Culture Process Parameters Using Raman Spectroscopy

  Today’s mammalian cell culture monitoring strategies are complex and highly variable, and yet only a handful of key parameters, such as temperature, pH, and dissolved oxygen (DO), are controlled in real-time. Measurement... read more
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  Improving Preclinical Outcomes: De-Risking Your Drug Development Program

  Introducing a new drug candidate to market is a complex and time-intensive process that can cost pharmaceutical companies $1 billion and more than a decade of research and development. Coupled with the fact that only ... read more
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  Microbial Control Strategy for iNeST mRNA a Cell-Free, Individualized ATMP

  Advanced therapy medicinal products (ATMPs) also referred to as Cell and Gene Therapy products (CGT) are a new class of drugs which is fundamentally different from traditional drugs like therapeutic antibodies or small ... read more
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  Modern Perspectives on LAL Non-Endotoxin Reactivity

  Take a minute to look outside. Hopefully you see some trees, grass, and dead leaves in the fall. What you likely don’t see but is everywhere as well are fungi and yeast on the plants and in the soil. This all drains into... read more
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  Insights Into Designing Peptide-Based Libraries for Drug Discovery

  Successful drug discovery often involves protein studies, because most drugs are designed either to interact with specific target proteins, or to alter target protein-protein interactions. Current approaches toward a ... read more
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  The Future of Vaccinations and Prefilled Syringes in Deep Cold Storage

  COVID-19 vaccines have been developed in response to the worldwide pandemic at an incredible rate. By November 9, 2021, 7.3 billion COVID-19 vaccine doses had been delivered worldwide, with approx. 30.3 million doses ... read more
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  The EU Orphan Drug Designation – Securing The “Significant Benefit(s)”

  There are key eligibility criteria to consider when preparing an EU orphan drug designation (ODD) application (different to that of the US); one of which is justifying the “significant benefit” of ones’ product over ... read more
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  Optimizing and Future-Proofing Bacterial Endotoxin Testing with Flexible Automation

  Bacterial Endotoxin Testing (BET) is a fundamental requirement in the biomedical and pharmaceutical industries to ensure patient safety. However, both sample types and assays can be highly variable, making automation a ... read more
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  An Interview with Renee Morley, MBA

  Contec. Inc. is an experienced global leader in wipers, mops, and disinfectants for the pharmaceutical industry. Contec focuses on providing the industry with the highest quality products to meet challenging ... read more
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  An Interview with Kaitlyn Vap and Hayden Skalski

  Biopharmaceutical companies obtain research and development expertise to progress pipeline development projects. While these companies also have internal manufacturing expertise, it is often not to the scale of contract ... read more
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  Executive Q&A - Peptide Analysis Workflow for mAbs

  A peptide is simply a short chain of amino acids, connected by peptide bonds (a type of covalent bond formed between a carboxyl group on one side and an amine on the other). A monoclonal antibody is a large protein ... read more
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  Endotoxin Testing - Why and How the Industry Seeks Improvements

  The bacterial endotoxins test (BET) is a critical quality control release test, which means that life changing products cannot be released to the public for use until they pass this test. For the past 30 years, the ... read more
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  Disinfectant Rotation and the Frequency of Use of a Sporicidal Agent

  Historically, the term rotation was applied to alternating the type of daily disinfectant selected. The thought was that microbes could adapt to one disinfectant chemistry and the disinfectant would no longer remain ... read more
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  Pharmaceutical P.I.N. Points - Patent Innovation News

  The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in August–September 2021. read more
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  Year-End Musings

  “Life should not be a journey to the grave with the intention of arriving safely in a pretty and well-preserved body, but rather to skid in broadside in a cloud of smoke, thoroughly used up, totally worn out, and loudly ... read more