Injectable Drug Delivery Articles

  1. M&A In GLP-1 Technology: Practical Recommendations And Best Practices 11/4/2025

    With explosive demand, expanding indications, and rapid innovation, the GLP-1 revolution is reshaping dealmaking. Here's a practical guide for companies negotiating M&A in this arena.

  2. Drug Delivery Innovation: Getting Advanced Therapies To Patients 11/3/2025

    In this article, Fran DeGrazio recounts the evolution of drug delivery technologies as she underscores the need to innovate in the delivery of advanced therapies. Considering chronic diseases, rare diseases, and difficult-to-reach therapeutic targets, Fran offers suggestions for organizing and readying for the development and delivery of platforms, systems, and devices for next generation treatments, including personalized, precision medicines.

  3. CMC For Long-Acting Injectables For TB 10/3/2025

    Long-acting injectables are a potential treatment alternative for tuberculosis, but they require key development considerations from a chemistry, manufacturing, and controls perspective.

  4. Drug Delivery Product Strategy: Aligning The Organization For Execution 10/1/2025

    In this article, Fran DeGrazio offers recommendations to biopharmaceutical sponsor companies about best practices for aligning strategic product initiatives with functional area execution. She outlines 5 key considerations, illustrated with the increasingly common market strategy expansion from drug product development to drug-device combination product delivery.

  5. EU MDR: When Products Without An Intended Medical Purpose Meet Medicinal Substances 9/24/2025

    One major change introduced by the EU MDR compared to the former European directives is the inclusion of products without an intended medical purpose but with similar risk profiles to medical devices, such as dermal fillers.

  6. 7 Management Strategies For Combination Product Regulatory Success 9/2/2025

    In this article, Fran DeGrazio lays out best practices for biopharma executive leadership and non-technical managers to sustain regulatory momentum for their combination product development and commercialization. Fran points to cross-functional collaboration, quality management systems, regulatory documentation, and post-market surveillance as keys to drug delivery product success. 

  7. Improving Drug-Device Combination Product Co-Development 8/8/2025

    Early recognition and mitigation of drug and device integration difficulties are critical to the success of combination products. The collaborative effort in development cannot be overstated. 

  8. Inside Arbor Biotech's In Vivo Gene Therapy Approach 8/6/2025

    Following recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.

  9. Understanding Annex 1 For Sterile Medicinal Products 8/4/2025

    In this article, Fran DeGrazio outlines concepts from the EU Annex 1 guidance for sterile medicinal products. She highlights key considerations for the manufacturing of sterile products and offers recommendations for contamination control, facilities upgrades, quality risk management, testing, inspections, and personnel training. 

  10. New Regulatory Considerations For Animal Testing And The Consequences For Drug Product Formulation Development 7/3/2025

    The U.S. is experiencing a shift in the regulatory environment for animal testing, driven by the evolving use of AI. This impacts the formulation development approach for new drugs in the non-clinical phase.