BIO From The Editor and Guest Columns

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

    The explosion of gene therapy candidates in clinical development is being led by a diverse set of originators, including many hospital and university labs. While these are great incubators for innovation, the many small labs working in isolation do not have experience in commercializing a medicine for wide and sustained use in patients, and this could slow the acceptance of gene therapies for the people who really need them. Health authorities have recognized the importance of getting gene therapies into standard use and are supporting doing so with accelerated pathways.

  2. Improving Training In Biopharmaceutical Manufacturing

    Whether improvements in the delivery of training in biopharmaceutical manufacturing are needed is an open question, and the answers are not clear-cut. BioPlan recently conducted independent research to address this question.

  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 biosimilar medications 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 Than You Think

    The previous article in our "Identifying And Resolving Errors, Defects, And Problems Within Your Organization" series focused on identifying manufacturing trends so you can know when to act. This one discusses what needs to happen when a defect or nonconformance is detected and needs to be investigated, explaining one of the most broadly applicable and durable root cause analysis tools: the fishbone diagram.

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

    Pharma companies ignore the issue of counterfeiting and drug diversion at their own peril. This article discusses noteworthy examples of how drug manufacturers of various sizes are tackling this problem.

  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 (CT/GT). These therapies, once considered a kind of “wild-west,” are becoming more widely accepted. Still, the task of seeking approval from the FDA can be extremely challenging. It’s become vital to get your relationship with the FDA off to a solid start from day one.

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

    In the global biosimilars industry, regulations are administered locally, on a country-by-country basis, inevitably leading to inefficiencies and contradictions in regulatory requirements for biosimilar approval from one country to the next. If those inefficiencies are too great, some companies may delay or forego entirely seeking approval in a jurisdiction where the costs or uncertainties of the regulatory path are too high. 

  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. Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations

    I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.