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Current Trends in Host Cell Protein Detection for Biologics ManufacturingIn this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.
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Effective and Efficient Weighing of Potent CompoundsThe advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.
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A Novel Cell Lysis Method to Improve the Viral Vector Manufacturing ProcessResearchers demonstrated a new cell lysis method using a novel solution to improve viral vector production.
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The potential of CROMA continuous coaterCROMA continuous coater brings an innovative technological progress in manufacturing based on modularity and truly continuous film coating of tables.
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The Global Regulatory VillageHarmonization of global regulations fosters innovation and ensures quality medicines.
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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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Using Image Analysis to Differentiate Particle Size and Shape in Drug Products with Multiple ComponentsImage analysis is crucial for particle analysis of complex finished drug products.
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Why Are Pharmaceutical Companies Reluctant to Adopt Cloud Technologies?Despite its understandable hesitancy, the pharma industry is facing a need for more widespread adoption of cloud-based solutions.
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Highly Efficient Olefin-Metathesis CatalystsThe authors describe the Piers' catalysts and detail latest progress in olefin-metathesis catalyst technology.
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Improving IR Spectroscopy as a Tool for Biopharmaceutical AnalysisA recent innovation in infrared spectroscopy, Microfluidic Modulation Spectroscopy has been shown to improve characterization of secondary protein structure.
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Understanding Excipient Characteristics to Ensure Robust Continuous ManufacturingKey information is needed for excipients and their potential impact on continuous manufacturing processes.
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What Is Hindering The Uptake Of Biosimilars?The biggest differences between the development of a biosimilar and a generic medicine lie primarily in the preclinical and clinical stages.
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Spray Drying as an Enabling Technology for Inhalation Drug DeliveryParticle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.
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Advancing Detection of Unknown ImpuritiesHaving intelligent analytical tools can advance the detection of unknown impurities, which is important for ensuring small-molecule ingredient purity.
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Technology as a New Evolution in Fighting DiseaseAdvancing the use of AI to understand the whole of a disease can reveal drug development insights that lead to drug discovery breakthroughs.
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Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine ManufacturingThis article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.
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The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
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Use Of RFID Asset Management Systems For Monitoring Analytical InstrumentationUtilizing integrated active radio frequency identification (RFID) and real-time asset management systems can yield commercial and compliance benefits.
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Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference StandardChange of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
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Innovations in Parenteral Medicines PackagingParenteral drugs are becoming increasingly complex, creating new challenges and opportunities. This paper explores potential innovations across the entire value chain.
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Challenges Of Particle CharacterisationParticle characteristics can affect pharmaceutical formulations and products in a number of ways, and a variety of techniques are available that enable particle monitoring and characterisation.
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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Assessment of Nanosuspension Formulation for Intranasal AdministrationResearch suggests that intranasal nanosuspensions offer a promising way to formulate and deliver drugs that are poorly soluble in water to patients with chronic conditions.
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Why Syringes Continue To Dominate The Parenteral Drug Delivery MarketThe application of the first piston syringes to treat medical complications was described in Roman times during the 1st century, and forms of intravenous injection and infusion began as early as 1670.
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Assessing Legacy Drug QualityA data-driven strategy can assess the quality of legacy drugs developed before 2011 process-validation requirements were established.
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Current Trends in Host Cell Protein Detection for Biologics ManufacturingIn this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.
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Review of FDA Warning LettersThe author reviews Warning Letters issued between 2000 and mid-2010 for aseptic processing and non-sterile processing, and determines how many observations were made for each section of the GMPs.
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A Novel Cell Lysis Method to Improve the Viral Vector Manufacturing ProcessResearchers demonstrated a new cell lysis method using a novel solution to improve viral vector production.
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Part 1 of 4: Pharma 4.0 and Digital TransformationAn Overview with Aubrey Hogan Verista’s Head of Regulatory Compliance and Product Lifecycle Management
