Industry Insights

  1. ADC Manufacturing's Biggest CMC Challenges And Ways To Approach Them 2/19/2025

    Manufacturing ADCs is inherently more complex than other biologic drug products. Let's explore some of the key issues, including aggregation, solubility, and thermal instability.

  2. Driving Product Success: Navigating The Clinical To Commercial Transition For Autologous Therapies 12/1/2021

    As the number of cell therapy agents in the global pipeline continues to increase, it’s critical that therapy innovators take the necessary steps, including identifying the right partners, to navigate the challenges of moving from clinical to commercial development. 

  3. Analytical Considerations For Biopharmas During Commercialization

    As a project approaches its process performance qualification phase, it is crucial to understand the expectations of regulatory agencies and identify the most efficient ways to validate the analytical methods.

  4. How To Optimize Downstream Separation With Tagless Proteins 2/26/2025

    The intein-based magnetic bead system enables effective affinity capture, tag removal, and buffer exchange, supporting direct analytical applications.

  5. Principles of Technology Transfer 3/1/2016

    In the context of contract drug development and manufacturing, transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacturing sites.” It is the systematic procedure that is followed to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible party.

  6. The Cancer Drug Shortage: When Quality Fails 7/7/2023

    Our industry is failing cancer patients with the current cancer drug shortage. Why is this happening and what can we do about it? This expert provides her insights from the perspective of a quality control professional.

  7. Using AI To Predict Multispecific Formulation Patterns 5/16/2025

    This emerging class brings substantial formulation challenges beyond those of traditional mAbs. Here’s a comprehensive look at the issues and some solutions.

  8. Using Advanced Mass Spectrometry To Analyze APIs And Impurities 3/17/2023

    Characterizing impurities through advanced analytics is a critical step in ensuring biotherapeutic product quality. Learn more about the growing role of CDMOs in developing these products.

  9. Evaluating The Potential Impact Of Anti-BCMA Therapies In The Multiple Myeloma Space 10/30/2020

    There are more than 70 ongoing clinical trials in development investigating over 30 B-cell maturation antigen (BCMA) targeting agents, each utilizing innovative technologies and strategies such as antibody-drug conjugates, bispecific antibodies, and CAR T cell therapies. This article reviews three key anti-BCMA therapies in late-phase clinical development that are likely to impact multiple myeloma treatment.

  10. How To Integrate CPV & APR For Biologics 1/3/2022

    In biologics manufacturing, continued process verification (CPV) requirements are similar to those for evaluating quality standards that determine changes to manufacturing or control procedures in an annual product review (APR). Many companies have mirrored CPV and APR reporting processes. Few have realized the efficiencies of integrating them.