Articles, App Notes, Case Studies, & White Papers

  1. FAQs On The Revised EU GMP Annex 1: Volume 1 3/5/2025

    The revised GMP Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, which aim to minimize contamination and ensure patient safety.

  2. Solid Form Screening, Rapid Formulation Selection To Meet Tight Timelines

    A comprehensive approach to evaluating drug molecules for the selection of a lead solid form and formulation can significantly accelerate development timelines and limit risks in later development.

  3. The Paradigm Shift: From Scale-Up To Scale-Out In Genetic Medicine 2/18/2025

    The shift from "scale-up" to "scale-out" in genetic medicine enhances production speed, revolutionizing pharmaceutical manufacturing and accelerating life-saving therapies for global patient populations.

  4. Sophisticated Formulation Approaches For Insoluble Drug Candidates 1/24/2022

    A sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.

  5. Sub-Contracted Process Characterization Study: Practical Considerations

    To maximize the benefit of outsourcing a PC program, consider three specific factors that will help to ensure the program runs well without rework or changes of scope throughout the program.

  6. PFAS In Medical Devices: Expert Insights On Frequently Asked Questions 1/2/2025

    Watch to learn more about PFAs in medical devices, covering environmental concerns, health risks, testing, alternatives and management strategies with Shalene Thomas of Battelle.

  7. Comparing Vial Container Closure Systems

    Examine a case study where two 20mm vial CCSs were compared using the DeltaCube™ Modeling Platform and experimentally show the link between prediction and real performance.

  8. Early Decisions To De-Risk The Transition To Combination Products

    The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?

  9. Overcome Common Pre-Filled Syringe Challenges Through Partnership 5/23/2025

    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.

  10. Is It Ever Too Soon To Start Your Extractables And Leachables Assessment?

    Learn what you need to know about planning for your extractables and leachables testing programs to mitigate delays to your drug development timelines.