Featured Editorial

  1. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

    The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

  2. How Modular Facility Design Can Accelerate GMP Facility Construction 5/20/2025

    Autolus Therapeutics' COO talks about the accelerated construction of the company's cell therapy manufacturing facility, The Nucleus.

  3. How Modeling Predicts Bottlenecks In Takeda's Multimodal Facilities 5/20/2025

    A functional simulation requires many manual inputs, including data smoothing, vendor collaboration, and even direct communication with tenured employees who know the job best.

  4. Will Genome Modifications Define Next-Gen AAV Vectors? 5/20/2025

    AAV vectors composed of naturally occurring capsids are suboptimal. Gentle genetic alterations hold promise for safer, more efficient therapy.

  5. Formulation Is Key For Y-mAbs' Self-Assembling Antibody 5/16/2025

    The radiotherapy company's novel SADA construct uses self-assembling tetramers to deliver isotopes directly to cancer cells for a highly targeted, less toxic treatment.

  6. AI's Potential To Aid Multispecific Analytical Characterization 5/16/2025

    Orthogonal analytical techniques are essential to characterize CQAs, support regulatory submissions, and validate AI-predicted formulation strategies.

     

  7. Using AI To Predict Multispecific Formulation Patterns 5/16/2025

    This emerging class brings substantial formulation challenges beyond those of traditional mAbs. Here’s a comprehensive look at the issues and some solutions.

  8. Good Distribution Practice Is Evolving — Here's How 5/15/2025

    Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.

  9. The 3 Phases of QRM – An Inspector's View 5/14/2025

    Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.

  10. ADCs Unleashed: Navigating Development Hurdles In Targeted Cancer Therapy 5/12/2025

    Despite their potential to revolutionize treatment paradigms, antibody-drug conjugates (ADCs) face challenges that companies must tackle for successful development.