Industry Insights

  1. Cell And Gene Therapies: Solving Six Challenges 9/20/2021

    This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.

  2. Repurposing A Facility For Cell & Gene Therapies: Demo & Engineering 7/30/2020

    Cell therapy capacity is in high demand, real estate and property are generally available at sites around the world, and the tendency is to place cell therapy production in an existing site. The challenge is to make the renovated space a successful GMP facility by engineering and building it correctly within the confines of the space and utilities.

  3. Guide To PUPSIT And Annex 1 In Aseptic Processing 12/5/2024

    Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.

  4. The Key To Painless Data Integrity For Bioanalysis Labs 2/10/2023

    Learn more about a significant area of opportunity for improvement when addressing the inefficiencies in manual record keeping and data management.

  5. How Two Life Science Leaders Unlocked Pharma 4.0 Success 8/22/2024

    Gain valuable insights from digitalization leaders on how some life sciences manufacturers are successfully scaling their Pharma 4.0 initiatives beyond the pilot stage and paving the way forward.

  6. COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain 3/26/2020

    To address the current worldwide COVID-19 pandemic, more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation.

  7. Cell Therapies For Solid Tumors: Considerations To Make Before Embarking 4/1/2022

    Cell therapy developers are running into unique scientific challenges that must be overcome before a novel cellular therapy in solid tumors can show compelling proof of efficacy. This article examines considerations for cell therapy developers as well as considerations for those who are looking to invest in or acquire companies developing such therapies.

  8. A Practical Guide To Defining Priority Data In MES 3/17/2025

    Manufacturing execution systems (MES) play a crucial role in pharma/biotech, but MES platforms face the challenge of identifying the critical data that should be prioritized for supporting effective operations.

  9. An Update On 2020 U.S. Biosimilars Regulation & Litigation 9/1/2020

    The biosimilar market and regulatory and legal landscape remained dynamic throughout the first half of 2020. Ongoing activity indicates that the remainder of 2020 should bring more interesting developments.

  10. Finding Biotech Funding In Volatile Times 6/8/2020

    Dr. Ben Zeskind founded Immuneering in 2008 as the economy spiraled into the Great Recession. Here, Zeskind tells us how he adjusted his fundraising strategy to build the foundation of a thriving company.