Industry Insights

  1. Process Development With “The End In Mind” For Startups 3/20/2024

    We encounter the term “the end in mind” in product development frequently, but many are unsure what it really means and when it matters. This article sheds light.

  2. A Snapshot Of What Pfizer's Doing With Teleoperated Robots 3/12/2025

    A robotic arm controlled with a virtual reality headset and input devices could aid in complex interventions where automation isn't practical.

  3. Slow-Walking The Isolator: A Cautionary Tale 12/2/2020

    Our industry has, with not insignificant regulatory assistance, obstructed the implementation of a technology that has proven safe and effective and was an enormous improvement over the conventional cleanrooms universally in place in the mid-1980s.

  4. Single-Use Bioreactors Gain Popularity Worldwide 9/29/2023

    Industry momentum is trending in favor of single-use bioreactors as a plurality of biopharma companies are opting for the disposable version of bioreactors, according to new market research. Let's look at the drivers of this change, regional analysis, and prominent vendors in the space.

  5. Evolving Solutions To Optimize Clinical Trial Decentralization

    The introduction of novel solutions to facilitate adherence can support decentralized trials and mitigate potential concerns surrounding reduced patient-physician touchpoints.

  6. Considerations For Successful Upstream Manufacturing Process Scale-Up

    A CDMO’s ability to scale seamlessly between bioreactor sizes is critical when adopting a client’s manufacturing process.

  7. Is It Time To Say Goodbye To FMEA Risk Priority Number (RPN) Scores? 4/27/2020

    It may be time to consider eliminating the use of the traditional risk priority number (RPN) score and transitioning to the use of action priority (AP) ratings. AP ratings are much simpler to use, do not require a calculation (eliminating the validation of a spreadsheet), and provides a single simple table reference to determine the appropriate level of action.

  8. Fast Track RNA-LNP Drug Development By Lowering The Lipid Barrier 8/21/2023

    Fast-track RNA-LNP development, streamline screening with off-the-shelf ionizable lipid mixes, and utilize validation strategies to generate reproducible and scalable LNPs for lead candidates.

  9. Applying The Johari Window To Manage Biopharma Supply Chain Risk 2/14/2020

    The recalls of generic versions of the drug valsartan and related products losartan and irbesartan due to nitrosamine impurities have put the spotlight on sourcing strategies and the globalization of the pharma supply chain. The Johari Window model can help minimize the risk inherent in a complex supply chain.

  10. 5 GCP Compliance Mistakes To Avoid With Job Descriptions, CVs, & Org Charts 9/11/2018

    When it comes to GCP audits and inspections, low-hanging fruit says a lot about the tree.