Articles

  1. Optimizing Your Clinical To Commercial Journey 8/22/2022

    How should you think about optimizing the journey from the development stage of clinical trials to commercialization? Review considerations to eliminate avoidable delays and have a seamless transition.

  2. Dual Sourcing: Mitigating Risk In Your Supply Chain 8/22/2022

    Dual sourcing should be implemented to reduce risk and ensure an uninterrupted supply of critical, life-saving therapies. Recent FDA draft guidelines recommend risk management plans to prevent drug product shortages.

  3. Broadening Our Biologics Footprint, Together 7/4/2022

    Explore the recent acquisition of Lyophilization Services of New England, Inc. (LSNE), the opportunities this presents to biopharma companies, and the current trends in the sterile fill-finish industry.

  4. Lyophilization vs. Liquid Formation: Why Lyo Offers Advantages 3/8/2022

    Lyophilization offers some alluring advantages in today’s complex market, but its challenges require innovation and expertise to surmount.

  5. Biologics Development, Manufacturing & Packaging Roundtable 11/16/2021

    A panel of experts discussed challenges and opportunities related to the development, clinical phases, and commercialization of biologics. They also offered insights on how to improve sponsor-CDMO relationships.

  6. Why Implement Aggregation Alongside Serialization Now? 10/13/2021

    Understand the business rationale for including aggregation as part of your serialization strategy, beyond the regulatory requirement.

  7. How Digitization Is Delivering Competitive Advantage In Device Assembly 9/20/2021

    Data and the digitization of assembly equipment work to deliver a competitive advantage to pharma partners in terms of quality, continuous improvement, de-risking maintenance, and change management.

  8. Transforming From Supply-Led To A Demand-Led Model To Support Commercial Gene Therapies 8/3/2021

    In gene therapies supply chains, the focus is entirely patient-centric and the ‘volumes’ can often be as low as 1 dose per batch/lot, so the supply and distribution model needs to be much more flexible and precise.

  9. How To Build A Robust Packaging Strategy For Rapid Commercialization 8/3/2021

    Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.

  10. Bulletproof Supply Chain: Hope For The Best, Prepare For The Worst 8/3/2021

    How to incorporate flexibility in planning to overcome potential challenges, the value of having a contingency plan, and how a risk-based approach can determine where a contingency plan is needed.