GUEST COLUMNISTS

• Formulation Is Key For Y-mAbs' Self-Assembling Antibody

  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.

• AI's Potential To Aid Multispecific Analytical Characterization

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

   

• Using AI To Predict Multispecific Formulation Patterns

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

• Good Distribution Practice Is Evolving — Here's How

  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.

• The 3 Phases of QRM – An Inspector's View

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

• ADCs Unleashed: Navigating Development Hurdles In Targeted Cancer Therapy

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

• The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials

  Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

• A Case For Paying Allogeneic Cell Therapy Product Donors

  The debate over whether to pay donors for cell therapy starting materials comes down to four areas of disagreement: altruism, availability, ethics, and safety.