INSIGHTS ON CONTRACT PHARMA MANUFACTURING

• Sterile Contract Manufacturing Selection: Aligning CGMP With Precise Product Requirements

  Partnering with an experienced sterile CMO is essential for small-batch injectables, requiring clear communication, quality alignment, and regulatory compliance to ensure manufacturing success.

• Guardians Of Precision: Regulatory Compliance And Audits For Parenteral Manufacturing Precision

  CMOs play a critical role in regulatory compliance for parenteral manufacturing, using audits, quality systems, and proactive strategies to ensure product safety and patient well-being.

• Consider Two Factors To Choose A CDMO For Developing Injectable Medicines

  Explore agile, expert CDMO services for injectable medicines, combining technical excellence and near-term availability to accelerate development and manufacturing for biopharma companies.

• Securing INmune Bio's Trial Materials In A Crisis

  Discover how a sudden biostorage shutdown put INmune Bio’s trial at risk, revealing the critical importance of logistics and rapid coordination in protecting advanced therapy programs.

• The World Outside Influencing Your Outsourcing Internals

  Tariffs, geopolitical gyrations, (pending) laws such as the BIOSECURE Act; all affect your outsourcing optionality and decision-making. Our panel of internationally savvy biopharma executives provide some guiding insights.

• Creating Your ADC Supply Chain

  Antibody-drug conjugates (ADCs) are on the rise. Supply chains to serve ADC developers can be complicated, and spread out. Reza Oliyai has some key interpretations of how these therapies can string together optimal - and at times far-reaching - supply chains.

• Your CDMO Knows A Lot - Are You Listening?

  Our three experienced panelists weigh in on how sponsors should take advantage of what CDMOs know from experience in quality, regulatory, and other aspects of development and processing.

• CDMO SOWs Must (Re-)Align With New Project Realities

  Decades of experience in cell and gene therapy outsourcing have taught Donna Rill, Chief Technology Officer, Triumvira Immunologics, that the key to success is ensuring CDMOs and sponsors understand the need to continuously align SOWs with the variances as projects move forward.

• It's Not What You Deserve, It's What You Negotiate

  Seshu Tummala of Uniquity Bio and Reza Oliyai of Oliyai Consulting Corporation discuss how to achieve your (at times evolving) goals and meet the needs of your CDMOs.

• Budgeting Key Component In Biologics Flexibility At CDMOs

  You want flexibility in scheduling, contracts, and the entire CDMO relationship. While money can't buy you love, it can go a long way in getting that more flexible partnership.