ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway

  Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.

• Beyond The Battery: Powering the Next Generation Of Active Implants

  Active implants are pushing past battery limits as energy‑harvesting taps motion, heat, and biochemical signals. Hybrid systems could shrink devices and enable longer‑lasting, self‑powered implants.

• Realizing The Promise Of New Approach Methodologies (NAMs)

  NAMs are transforming risk assessment. Learn how integrating advanced in vitro models and computational tools can improve efficiency, reduce costs, and strengthen regulatory decision-making.

• Is Your Combination Product Drug-Led Or Device-Led?

  The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”

• Overcome Common Pre-Filled Syringe Challenges Through Partnership

  The pre-filled syringe space is one of the fastest growing pharma sectors, offering greater patient safety and lower manufacturing costs. But pre-filled doesn’t translate to easily filled; there are particular obstacles to overcome.

• Understanding Injectable Drug Container Closure Systems

  Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

• The Algorithm Is In: 5 Ways AI Is Transforming Medicine

  AI is transforming the medical field, offering innovative solutions to complex problems. Explore the potential of AI in revolutionizing healthcare and leveraging data to improve patient experiences.

• Vial Containment Systems Based On Elastomer 4031/45 Gray

  Examine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.

• Key Considerations For Selecting Flexible Fillers

  Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

• Build A Vial-Stopper Combination Suitable For Drug Product Storage At -80°C

  This study worked to determine if the chosen vial-stopper-seal combination will remain integral while frozen at -80°C, under studied conditions, when the appropriate materials, processing, and sealing conditions are applied.