Featured Bioprocessing Editorial

  1. How FDA, Industry, And Academia Are Guiding AI Development In Biopharma

    Continuously learning systems (CLS) are artificial intelligence (AI) algorithms that constantly and automatically update themselves as they recognize patterns and behaviors from real-world data — enabling companies to become predictive, rather than reactive, with quality assurance. 

  2. FDA Considers These Risk Factors In Scheduling Drug GMP Inspections

    The globalization of the supply chain has expanded the scope of sites the FDA must routinely inspect from those in the U.S. to facilities worldwide.

  3. 4 Barriers To Cell And Gene Therapy Development For Rare Diseases — And How To Overcome Them

    A number of challenges are hindering efforts to develop cell and gene therapies to treat rare diseases. While these challenges may seem common across other drug markets, in the case of rare diseases, they are exacerbated by limited patient populations

  4. Could Naive Patients Be The Key To U.S. Biosimilar Success?

    A decade after the primary negotiations that resulted in the BPCIA, it is safe to say the promise of biosimilars is yet to be realized. As it turns out, perhaps naivety, in a clinical sense, is the solution.

  5. Single-Use Systems: The Benefits, The Challenges, And Selection Criteria

    The drive to reduce costs, increase speed to market, and meet regulatory requirements has led many pharmaceutical companies to look at single-use, pre-sterilized, plastic equipment systems as an alternative to stainless steel lines. Despite all the benefits — cost, efficiency, etc. — there are still challenges to implementing single-use systems.

  6. Bacterial Infections: Targeted Therapy Is A Page From Oncology Playbook

    This article focuses on approaches used to manage infections caused by common pathogens, the current landscape of targeted antibacterial therapy, and the challenges and areas of opportunity.

  7. Bridging The Public Knowledge Gap Around Cell And Gene Medicine

    According to a review of recent research studies that measured U.S. public opinion related to gene medicine, the public is not yet aware of gene medicine, is unfamiliar with the terms being used to describe the topic, and, when faced with multiple therapeutic options, is worried about making informed decisions.

  8. EMA’s Revised Format For Risk Management Plans: What You Need To Know

    The revised format for the EU Risk Management Plan (RMP) sets a new milestone in a progressive approach to risk management. The new RMP template can be used by RMP experts.

  9. Should You Rotate Disinfectants? Industry Experts Weigh In

    Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. This article discusses the concept of disinfectant rotation and the current mainstream industry practices.

  10. Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?

    In light of increased development and demand for biosimilars, as well as looming patent expiries, biologic developers are racing to release the next blockbuster biologic to replicate the success of past top-performers like Humira, and to prevent biosimilars from cannibalizing their market share.