Outsourced Pharma White Papers

  1. Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy 7/21/2020

    Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

  2. Allogeneic T-Cell Therapies: Efficient Commercial Manufacturing Readiness 7/13/2020

    A rationale-based methodology to address T-cell manufacturing challenges, based on the intended final manufacturing process, proposes a robust, scalable, cost-effective, and sustainable allogeneic platform.

  3. The Advantages And Challenges Of Fixed-Dose Combination Products 1/20/2022

    Understanding the significant competitive advantages of FDC products and the difficulties and potential pitfalls associated with their development and manufacturing in oral solid dosage forms is critical.

  4. Multiplexing: Managing Risk With Proven, Single-Use Solutions 10/19/2020

    Instead of trying to make better predictions or erring on the side of overcapacity, developers and CDMOs should seek manufacturing flexibility.

  5. Comparator Local Sourcing For Clinical Trials 8/24/2020

    This growing demand for comparators is causing many supply chain managers to explore available sourcing options. This paper examines the fundamentals of local sourcing, including the benefits and challenges of sourcing locally, and the circumstances under which local sourcing can be a sound decision. Recommendations are provided for avoiding common pitfalls in implementing a local sourcing strategy.

  6. The Development, Scale-Up, And Manufacturing Of Semi-Solid Dosage Forms 1/20/2022

    Topical products, whether prescription dermatological drugs or over-the-counter lotions, creams, or gels, present unique challenges in terms of development and manufacturing.

  7. Are End-To-End CDMO Partnerships The Solution To Drug Development And Manufacturing Upheaval? 1/24/2022

    Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future with uncertainty and disruption.

  8. Product Development For Oral Solid Dose Using Continuous Manufacturing 10/30/2020

    A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.

  9. Assessing End-To-End Drug Development Partnerships 1/24/2022

    As drug development becomes increasingly expensive and complex, pharma companies are relying on CDMOs. Consider the opportunities and challenges of end-to-end arrangements.

  10. NMR And Mass Spectrometry In Pharmaceutical Development 10/26/2020

    Together, nuclear magnetic resonance (NMR) and MS analysis can definitively identify reference standards, active pharmaceutical ingredients (APIs), or final drug product composition.