Industry Insights

  1. Calculating The Probability Of Passing The USP Dissolution Test 1/9/2023

    Dissolution tests are performed during drug manufacturing to ensure that the drug product meets the standards specified in the United States Pharmacopoeia (USP). This article calculates the probability of passing the USP dissolution test using Microsoft Excel, and it can be modified for any combination of Q, mean, and standard deviations.

  2. 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.

  3. End-To-End Development And Manufacturing: Small Volume Commercial Products

    To meet ambitious orphan drug development timelines, CDMOs must be able to scale quickly to progress from early clinical development to validation and commercial launch.

  4. Trends In Bioprocessing CDMO Selection

    Learn which CDMO characteristics experienced outsourcers value most from ISR’s Bioprocessing Market Trends and Outsourcing Dynamics report.

  5. How To Ease The Transition From IND-Enabling Studies To GMP Production 6/4/2024

    Slip-ups resulting from a lack of knowledge, experience, or training can lead to delays or even regulator intervention, depending on the severity of the issue.

  6. Tips For Filing Regenerative Medicine Patents 8/26/2022

    The patent eligibility requirement of U.S. patent law creates obstacles for the regenerative medicine sector. This article examines common regenerative medicine claims for cell and gene therapies as well as biologics that are likely patent ineligible and provides potential claim amendments and other strategies to be successful.

  7. LNP Formulation For mRNA Delivery 2/15/2023

    Microfluidic mixing is one of the most effective means to formulate LNPs for its scalability and reproducibility. Explore LNP formulation, polishing, sterile filtration of mRNA-LNPs, and more.

  8. Key Financial Considerations For Phase II Clinical Injectable Drug Manufacturing 9/9/2022

    This article highlights the importance of scalability and flexibility in the choice of an early-stage manufacturing strategy and how that decision impacts financial outcomes for a drug development program.

  9. How Oral Solid Coating Technologies Can Enhance Delivery Strategy

    With increasing molecule complexity posing growing challenges for formulation and manufacture, oral solids specialists require extensive expertise and cross-team collaboration to ensure project success.

  10. Selecting The Right pDNA Supplier: 10 Key Factors To Consider 3/13/2024

    Selecting the right pDNA supplier is a critical decision that can significantly impact the success of your project or research. Consider these 10 key factors to help you make an informed choice.