Industry Insights

  1. Scaling Cell and Gene Therapy Manufacturing Operations 10/13/2020

    Manufacturing autologous cell therapy products faces few key complications, which is typically why CAR-T manufacturing runs at two or three sigma operations.

  2. Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity 8/18/2021

    The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.

  3. Targeted Protein Degraders: Transforming Oral Therapeutics 8/11/2025

    CDMOs play a critical role in TPD development by offering specialized infrastructure and analytical capabilities to support the transition from preclinical research to clinical supply and commercialization.

  4. Taste-Masking: A Unique Solution To Improve Patient Compliance 8/10/2021

    Taste plays an especially important role in pediatric medications, but it can affect adult compliance as well. No matter age, if you have poor-tasting medicine, you’re more likely not to take every dosage.

  5. FDA User Fee Programs Reauthorized: FDA's CBER Is A Clear Winner 10/6/2022

    Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the very date that the programs were scheduled to sunset. This article sums up the key takeaways, CBER's reorganization with new product-specific offices, and more.

  6. A Structured Approach To Regulatory Information Management Vendor Selection 3/13/2024

    Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.

  7. Getting Your Proof Of Clonality Right For Regulators 2/27/2026

    Regulators require clear, verifiable proof that production cell lines originate from a single progenitor cell, supported by strong imaging, documentation, and data integrity to ensure product consistency and safety.

  8. 5 Best Practices Merck Used To Implement Strategic Sourcing Partnerships 3/21/2019

    When Merck & Co., Inc. decided to shift from limited, tactical, piecemeal outsourcing to a strategic outsourcing model, the company implemented 10 key elements that were critical to the success of these strategic partnerships.

  9. Stable Bulk Cultures: A Fast Path To Antibody Manufacturing 7/25/2024

    The potential advantages that stable bulk cultures can offer a drug development paradigm are poised to accelerate and bolster biopharmaceutical clinical manufacturing.

  10. FDA Seeks Comment On Conducting Remote Regulatory Assessments 8/11/2022

    The FDA believes the use of both voluntary and mandatory remote regulatory assessments (RRAs) for all types of FDA-regulated products is in the interest of public health. The document describes the difference between voluntary and mandatory RRAs and shares information about the RRA report. Public comment ends on Sept. 30, 2022.