GUEST COLUMNISTS

• The EU Overhauls Pharma Laws: What You Need To Know

  On Sept. 18, the Council of the EU published the almost-final text of a major overhaul of the EU pharmaceutical laws. The final binding text is expected to be published very soon.

• Can Peptide Mapping Predict Intact Antibody PTM Distributions?

  Peptide mapping quantifies modification at individual sites, but the same site-level results can correspond to different distributions across intact molecules.

• An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?

  FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

• Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty

  Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.

• Is Your Supply Chain Ready For The End Of Class VI?

  Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

• When Lyophilization Fails At Scale, First Scrutinize Your Formulation

  When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.

• The 5 Shifts That Could Remake Lyophilization By 2040

  Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.