Featured Bioprocessing Editorial

  1. Developing Control Strategies For Gene Therapy Products — What Role Should CMOs Play?

    CMOs are positioned to play a leading role in standardizing control strategies for gene therapy because so many gene therapy products are funneled through CMOs for commercial scale production.

  2. Improving Training In Biopharmaceutical Manufacturing

    The bioprocessing industry is continuing to invest in training as it seeks to avoid problems and capacity constraints. And while budgets are increasing, new practices such as online components, standardization, and the development of accredited/certified training have not been adopted yet. 

  3. Are You Asking Too Much From Your Filler?

    The core mission of the pharmaceutical industry is to manufacture products for patients to cure them, vaccinate them, or alleviate a symptom, often by manufacturing a liquid injectable or an oral solid, among other therapies. In this article, we will focus on the aseptic injectable, from a general standpoint, to see what we are doing with our aseptic filling systems and why.

  4. The Current State Of U.S. Biosimilar Policies — An Overview

    With the continued policy dialogue on how rising drug costs impact patient access, the theoretical cost savings that biosimilars may offer is intriguing to many policymakers as well as those in the industry. 

  5. When To Use A Fishbone Diagram And Why You Should Do It More Often

    This article provides an in-depth and comprehensive explation one of the most broadly applicable and durable root cause analysis tools to investigate the quality of your manufacturing processes: the fishbone diagram.

  6. 5 Strategies To Combat Counterfeit Drugs And Supply Chain Threats

    It’s hard enough to detect errors in the entire process of manufacturing and distributing one’s own pharmaceutical products, but pharma companies must also address the challenge of counterfeit medications that at best are ineffective and at worst are deadly.

  7. CMC For Cell & Gene Therapies: 4 Topics To Discuss During Pre-IND Meetings With FDA

    Seeking early guidance from regulators can be invaluable when navigating preliminary product development strategies. The need for feedback increases significantly when working with cell and gene therapy products. 

  8. Biosimilar Regulatory Inefficiencies: Would Data Sharing Violate The U.S. Constitution?

    One of the regulatory inefficiencies the FDA is trying to address is the current requirement for bridging studies to submit data comparing a biosimilar to a non-U.S. licensed product.

  9. A Standard Approach To Classify Visible Particles In Parenteral Products

    The presence of visible particles in parenteral biopharmaceuticals remains a hot topic in the industry. Despite regulatory bodies targeting a goal of no visible particles, and despite industry’s focus on further improving the efficacy of inspection processes, particles will continue to be found during production and in the marketplace.

  10. Batch Testing And Brexit: 4 Things You Need To Know

    The U.K. has until March 29, 2019, to negotiate a deal with the EU to remain a member of the EMA. If no agreement is reached, MHRA has set forth the principles that will be in place on March 30 in case of a “no deal” scenario.