Industry Insights

  1. Incorporating Excipients Into QbD Studies For Drug Development — An Introduction 2/24/2021

    This article is the first in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design, published by the International Pharmaceutical Excipients Council Federation. Topics covered include measuring the impact of excipient variability on finished product quality and more!

  2. The 3 Most Overlooked Costs In Monoclonal Antibody Production 4/11/2025

    Explore the dynamic field of therapeutic biotechnology, examining the intricacies of mAb manufacturing and uncovering the often-overlooked factors driving high production costs.

  3. DNA To IND In 13 Months: A CMC Strategy For Bispecifics

    In its commitment to the delivery of novel molecular formats, Lonza has designed a CMC strategy for bispecific molecules that enables delivery of a data package for IND submission within 13 months.*

  4. 7 Rules For Properly Interpreting Control Charts 2/15/2021

    It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements. 

  5. Why Manual CQV Costs More Than You Think 5/6/2025

    Discover how modernizing commissioning, qualification, and validation processes in pharmaceutical and biotech manufacturing can streamline operations, reduce risks, and enhance efficiency to ensure compliance.

  6. How Continuous Bioprocessing Is Shaping Modern Biopharma Manufacturing 3/28/2024

    Continuous processing adoption so far has been slow; however, market research shows demand and capacity will grow significantly over the next four years.

  7. ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity 3/7/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.

  8. Immunoassays As An Imperative For Successful Gene Therapy Commercialization: Launch Challenges With Immunoassays And A Framework For Success 8/11/2022

    Rather than being seen as a secondary activity, immunoassays should be viewed as business-critical efforts with potential to create competitive advantage for gene therapy manufacturers. 

  9. How To Unlock Efficiency In MES Integrations 5/16/2024

    This article outlines the significant benefits and framework for manufacturing execution system (MES) integration with systems such as enterprise resource planning.

  10. FDA's 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch 3/19/2021

    Examine key elements from the report “Advancing Regulatory Science at FDA: FARS” that provide meaningful regulatory insight on new and emerging approaches to drug development and governance.