Featured Bioprocessing Editorial

  1. Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty 11/13/2020

    Unfortunately, the pharmaceutical industry does not understand how to control a risk’s likelihood of occurrence. The current draft of EU GMP Annex 1 is an example of the industry’s focus on a risk’s severity while not understanding or evaluating a risk’s uncertainty and thus defaulting to using the precautionary principle for guidance.

  2. Advanced Computing In Pharma & Medtech: How Cognitive Biases Can Cost You Millions 11/11/2020

    In their race to leverage sophisticated computing technologies (particularly artificial intelligence, robotics, augmented/virtual reality, and IoT), life science companies face a hidden, insidious challenge — avoiding the cognitive biases that can cause them to unwittingly exacerbate already business-threatening cyber risks.

  3. Human Performance In Biopharma Operations — Your Problem Isn’t Error 11/9/2020

    Part 1 of a two-part roundtable discusses key drivers for human performance improvement, lean manufacturing and human performance programs, and perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines. 

  4. Cleaning Process Development: Selection Of Cleaning Agents For Pharmaceutical Products 11/6/2020

    This article will discuss how bench-scale studies can be used for selecting the best cleaning agent for certain products and provide answers to the questions "Which cleaning agent provides the best cleaning?" and "Can we demonstrate that two cleaning agents are equivalent?"

  5. Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity 11/4/2020

    Most of the development in immunology to date has happened in rheumatologic, dermatologic, and respiratory indications. Nephrology, on the other hand, the medical branch that focuses on kidney diseases, has few approved treatment options outside of those that are expensive and higher risk, such as dialysis and transplants. 

  6. Interacting With FDA During Biosimilar Development: From Initial Advisory Meeting To BLA 11/3/2020

    In Part 2 of this two-part article, we discuss what information is critical to support the sponsor’s argument that the proposed product is biosimilar to the designated reference product and when is it appropriate and at what level of detail it should be for each stage of interaction with the FDA.

  7. Best Practices For Selecting & Implementing New Technology In The Life Sciences 11/2/2020

    Software tools and their supporting hardware can undoubtedly enable greater performance within your medical device, pharmaceutical, or biotech business. Regardless of the type of technology implementation, how you select technology and how you implement it are two critical factors for any organization.

  8. 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.

  9. How To Implement Continuous Process Monitoring Of Validated Processes 10/28/2020

    It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.

     

  10. Mapping The Development Of A Biosimilar Candidate: Analytical & Regulatory Decisions 10/27/2020

    This article, the first in a two-part series, details the biosimilar development path to identify and evaluate critical quality attributes for both the candidate biosimilar and the reference product, along the regulatory timeline.