Industry Insights

  1. Novel Approaches For Obtaining High-productivity Clones 1/30/2024

    Let's dig into cell line selection approaches, transposons to increase copy number for the gene of interest, and targeted integration to rapidly obtain high-productivity clones.

  2. Back To Basics: 505(b)(2) FAQs Part 1 8/27/2021

    The topic of this post will be general 505(b)(2) questions, including what is and is not allowed for an approval via the 505(b)(2) regulatory pathway.

  3. Gene Therapies: A Guide To Aseptic Single-Use Connectors 3/9/2022

    It's important to frequently evaluate your manufacturing process, gauging if improvements can be made. Learn how aseptic connections can impact your efficiency and speed as you continue to scale-up.

  4. Building AAV Manufacturing Capacity For Large Patient Diseases 11/15/2023

    AAV-based gene therapies are poised to treat larger patient populations with diseases like cardiovascular and neurological conditions. But scaling poses safety and manufacturing challenges. This deep dive into the issues could help companies clear away some of those obstacles. 

  5. FDA FY2019 Warning Letters: A Closer Look At Drug Manufacturers 2/28/2020

    Part two of this series takes a deep dive into the types of drug manufacturers that received warning letters and their locations, including data on how frequently the FDA recommends that firms hire qualified consultants and its request for “independent assessments” in warning letters.
     

  6. A Semi-Continuous Operations Model For Solid-Dose Manufacturing 11/1/2017

    The estimated timeline for a drug product from discovery to market is 10 to 15 years. However, less than 12 percent of drug candidates that enter clinical trials will ultimately receive FDA approval. The Orphan Drugs Act of 1983 ensured that there were adequate incentives offered to drug developers working on therapies to treat fewer than 200,000 patients in U.S.

  7. How Does The FDA's Process Validation Guidance Simplify A Technology Transfer? 8/3/2016

    The technology transfer of a process, whether it is from R&D to commercial manufacturing or from one manufacturing site to another, is a critical step in the life cycle of any drug product.

  8. Taste Masking 101: Optimize Taste And Improve Patient Outcomes 8/18/2022

    Taste masking is integral for a drug product’s final formulation. It can serve to increase patient acceptability and adherence to a therapy, in turn bolstering regulatory acceptance and commercial potential.

  9. COVID-19's Impact On The Clinical Trial Ancillary Supplies Industry 9/24/2020

    With restrictions on logistics, and countries implementing new restrictions to address increasing COVID-19 cases, it’s important to understand how to manage clinical trials’ ancillary supplies — like sourcing from the right suppliers, managing distribution to all trial sites, stock management, and response to new regulations.

  10. How To Mitigate Single-Use Supply Chain Risks 3/23/2015

    This example goes to show that manufacturers of pharmaceuticals need to not only understand their immediate suppliers (or tier-one suppliers), but also their tier-two suppliers and beyond, as quality problems with components may originate as far down the chain as tier-three and even tier-four suppliers.