ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Why Connect An Auto-Injector To A Smartphone?

  Why would a person with diabetes want to link their auto-injector to the Internet? Given that smartphones are so central to our everyday lives, it could be argued that the better question is: Why not? 

• A Lifecycle Management Strategy For Sterile Injectables

  Gain insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.

• Four Challenges That Stall Advanced Therapy Development

  Many challenges can stall an advanced therapy’s development, and the vast majority of them are tied to inadequate preclinical planning and partner vetting. Find how to foster a better development strategy.

• Solving For The Future Of Drug Delivery

  Next-gen therapeutics require equally advanced delivery systems—localized, personalized, and precise—to ensure efficacy, safety, and scalability. Delivery is now a central driver of innovation.

• Transitioning From Vial To Prefilled Syringe

  Understand how formulation development for a prefilled syringe affects manufacturing, driving the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

• Contract Design And Development Vs. In-House: How To Find The Best Fit

  Explore the rationale behind opting for a contract development organization (CDO) to fulfill organizational requirements and underscore vital considerations for evaluating CDOs to ensure alignment with your project objectives.

• From Regulators To PUPSIT: Notes On Annex 1 Revision Implementation

  Kevin Smyth, a biochemical engineer with 30 years of experience in the pharmaceutical industry, offers insights and expertise in working with firms to understand what regulators seek to meet new standards.

• Responding To Trends In Prefilled Delivery: Component Assessment And Selection

  Existing plunger technology for PFS was developed for manual injection and does not meet the evolving requirements for drug delivery especially for consistency of injection rate.

• Aseptic Filling And Processing Considerations For Biosimilars

  One of the most intriguing, high-stakes aspects of R&D is the realm of biosimilars. Explore the challenges of biosimilar production as well as aseptic processing considerations for biosimilars.

• A Risk-Based Approach To Injectable Combination Product Development

  Examine how to establish a holistic approach to drug-device combination product (DDCP) development and how to assess and manage risk throughout the development and approval process.