BIO From The Editor and Guest Columns

  1. What Is Pharmaceutical Innovation, Anyway? Italy’s New Algorithm & The Global Trend

    Innovation has long been a topic of focus in the pharmaceutical industry, with developers striving for it, regulators and payers demanding it, and everyone — from patients to manufacturers — worrying about who is going to pay for it. Something that often gets lost in the conversation is: What exactly do we mean when we talk about “innovation”?

  2. How To Successfully Manage Packaging And Labeling During Pharma Product Launches

    If you are charged with any of the tasks that lead to a successful product launch in the pharmaceutical industry, you know how critical it is to execute a multitude of steps successfully. Among these are agreement by marketing on the look and design of the campaign, completion of clinical trials, project management, testing of active pharmaceutical ingredients, the completion of a trial production batch, receipt of all materials at the production site, production scheduling, regulatory agency submissions, trademark registration, and a host of others.

  3. 10 Steps To Develop A Sustainable Training Program For Pharma Operations

    Investing in training for employees in the life sciences and biopharmaceuticals industries generates quantifiable returns that go far beyond simply imparting specific, task-oriented knowledge. For example, effective and thoughtfully planned onboarding and sustainable training are key elements in attaining a culture of quality throughout the organization. Furthermore, inadequate training contributes to process and product variability.

  4. When The Goal Is To Be (Bio)similar, What Does Differentiation Mean?

    As concerns about the cost of medicines reach a fever pitch, innovators are looking to leverage a promising advancement to help address the fundamental need for sustainable healthcare in the U.S. — biosimilars.

  5. Designing An Environmental Monitoring Program For Non-Sterile Manufacturing: A Risk-Based Approach

    Microbial control for non-sterile manufacturing helps to ensure the safety and efficacy of pharmaceuticals. Products that are compromised with excessive amounts of microorganisms, specified microorganisms, or objectionable microorganisms may not be effective or could be dangerous to consumers. Unfortunately, the regulations governing non-sterile manufacturing are not as clear or as abundant as those for sterile manufacturing. This leads many manufacturers to utilize risk assessment analysis tools to adapt portions of sterile manufacturing guidelines when developing environmental monitoring programs for non-sterile environments.

  6. Biosimilar Regulatory Best Practices: Don’t Fear Exploration

    In the first of this two-part article, Sandoz's Cindy Cao shares lessons learned from working with the FDA and reveals that there is still a lot of room for exploration and innovation in biosimilar development.

  7. 5 Steps To Set Effective Goals For A Life Science Consultant

    There is a trend within the pharmaceutical, biopharmaceutical, medical device, and vaccine industries to hire more consultants, leading to a staffing ratio that can be up to 50 percent consultants to staff for small to large capital projects.

  8. “Human Error” Deviations: How You Can Stop Creating (Most Of) Them

    In the time it takes you to read this article, the industry will generate (conservatively) about 115 new process deviations, and about 65 of them will be misclassified as having something related to “human error” as either the principal causal factor or one of the proximal causal factors.

  9. Contingency Plans: An Essential Quality Management System Risk Tool

    Probably the biggest concern for anyone implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focused on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.

  10. Aseptic Processing Then & Now: What Have We Learned Over The Last 40 Years?

    This article is a brief retrospective on aseptic technology to help the current pharmaceutical generation understand the legacy of our business and provide a snapshot of where we have been and where we are going. The reader can decide if the changes reflect revolution, evolution, or simply adaptation.