GUEST COLUMNISTS

• The Strategic Role Of Cost Modeling In Pharmaceutical Procurement

  Selecting a CDMO depends on price, geography, expertise, and other variables. While price is often a key motivation for the decision, it is production cost that should be carefully considered. An independent analysis can be of great help. An Outsourced Pharma Board member presents some scenarios.

• ICH Revises Q1 Guideline, Advancing Stability Testing Standards

  In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

• Common Manufacturing Challenges For LBP Formulations

  As more companies explore live biotherapeutic products, ensuring stability is likely to be front and center with unique challenges for oral and topical applications.

• What CDMOs Wish Biotechs Knew Before Submitting An RFP

  This author has worked with CDMOs across different programs and therapeutic modalities. Each experience reinforced the same lesson: a strong RFP can make or break a partnership.

• 8 Actions To Redefine Sponsor–CDMO Relationships

  When viewing a CDMO as merely a service provider, interactions are often limited to completing tasks. This mindset can stifle innovation and problem-solving.

• We Must Rethink The Solvents We Use For Peptide Synthesis

  While the effectiveness of GLP-1 in weight loss is good news, the use of organic solvents in the GLP-1 synthesis and purification process is a growing pain that needs to be addressed.

• Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers

  The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts. 

• Why You Need A Raw Material Control Strategy

  You should start with the end goal in mind, but the first draft is almost never the last. These living documents should evolve as your team gains process knowledge.