FEATURED ARTICLES

• Real-Time Monitoring Of Solvent Clearance By TFF In The ADC Process

  Raman spectroscopy revolutionizes ADC manufacturing by enabling real-time monitoring of solvent clearance. Discover how it enhances process control, ensures regulatory compliance, and supports the production of high-quality therapeutics.

• Using Next Generation Sequencing To Test Raw Materials

  Explore the use of Next Generation Sequencing (NGS) to proactively screen raw materials in biopharmaceutical manufacturing, which aims to reduce viral contamination risks from animal-derived reagents.

• Replacement Of Traditional Adventitious Virus Testing

  Explore how molecular-based technologies, including PCR and Next Generation Sequencing, are transforming viral safety testing by offering broader, more effective alternatives to traditional animal-based methods like in vivo assays.

• Handling Protocols: Key Considerations In The Highly Potent API Market

  Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.

• Perfusion Cell Line Development For Intensified Processes

  The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.

• Helpful Biosafety Testing Innovations Where And When You Need Them

  Monoclonal antibody manufacturing is advancing to boost efficiency, cut costs, and expand access, driven by innovation, demand, and the rise of biosimilars.

• Process Analytical Technology In The ADC Bioconjugation Process

  Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.

• De-Mystifying Regulatory Support During Viral Vector-Based Development

  Navigating clinical trials for viral vector-based cell and gene therapies demands specialized expertise and regulatory insight. Learn how scientific acumen and strategic planning bring innovative therapies from lab to patient.

• A Novel Approach To Improving AAV Titers

  As demand for AAV-based therapies rises, optimizing production processes is essential. By utilizing existing technologies, tailored platforms, and optimized formulations, titers and productivity can be enhanced.

• Implementation Of Multi-Column Chromatography Systems

  Discover how a multi-column chromatography system enhances resin utility and enables continuous bioprocessing with minimal surge tankage for agile multi-product facilities.

• Tablet Manufacturing Technologies For Solid Drug Formulation

  Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.

• Advantages Of Spray-Dried Mannitol In Roll Compaction

  Pharmaceutical excipients like mannitol enhance formulation stability, flowability, and compressibility, which are crucial for robust tablets. Read how these properties improve patient compliance.

• Regulatory Frameworks For mRNA Therapeutics

  The RNA therapeutics and vaccines market has grown rapidly, driven by siRNA and mRNA technologies. Explore how these advancements are now being applied to cancer vaccines and innovative therapeutics.

• Navigating Next-Generation Quality Control Strategies For AAV Testing

  AAV-based gene therapies, while promising, require rigorous quality control through advanced methodologies to ensure safety, efficacy, and regulatory compliance.

• Improving API Solubility

  Ensuring adequate solubility is crucial for small molecule drugs' effectiveness. Find out how poor solubility remains a significant challenge, potentially hindering medications from reaching the market.

• Biologics Technology Transfer Guidebook

  Explore why technology transfer is a critical component in mammalian biologic drug development and manufacturing with the essential guide to biologics tech transfer that covers key strategies, best practices, and critical considerations.

• Multi-Attribute Method Analysis In Biopharmaceutical Development

  Analytics is a crucial element in biopharmaceutical development and manufacturing. Discover how Multi-Attribute Method (MAM) revolutionizes analytics to enhance quality control and regulatory compliance.

• Monitoring Microbial Contamination Of Mammalian Cell Cultures

  Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.

• Key Regulatory Considerations For The Next Wave Of Gene Therapies

  The evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.

• What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product

  Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.