Industry Insights

51. Synergies Between Vaccine Expertise On Developing, Manufacturing C&G Products 3/11/2025

    Understanding these synergies and their impact on efficiency, safety, and cost-effectiveness is essential for stakeholders navigating the complexities of CGT development and production.

52. The 6 Types of Bio/Pharmaceutical Consultants 10/26/2023

    In today’s consulting marketplace, there are numerous firms and individuals who consider themselves “consultants,” but, in fact, there are different types of consulting services. Determining which will serve you best is an important decision before you seek support. 

53. Finding Biotech Funding In Volatile Times 6/8/2020

    Dr. Ben Zeskind founded Immuneering in 2008 as the economy spiraled into the Great Recession. Here, Zeskind tells us how he adjusted his fundraising strategy to build the foundation of a thriving company.

54. Developing An Effective Lipid Nanoparticle Formulation Process For Small Molecule And Biologicals Delivery 3/1/2022

    Lipid nanoparticles (LNPs) are a versatile formulation technology used by drug development teams to deliver a variety of small/large molecules, peptides, and biologicals.

55. 5 Best Practices Merck Used To Implement Strategic Sourcing Partnerships 3/21/2019

    When Merck & Co., Inc. decided to shift from limited, tactical, piecemeal outsourcing to a strategic outsourcing model, the company implemented 10 key elements that were critical to the success of these strategic partnerships.

56. Should My Biotech Startup Buy Or Produce The Proteins We Use? 6/1/2023

    "Should we build out an internal group of scientific expertise or delegate work to external vendors?" It's a question that this author has faced in his career. He shares key considerations for building protein science teams.

57. Coming To America? 8 Steps For Successful U.S. Medtech Market Entry 9/14/2020

    Despite viable technologies and products, many medtech companies seeking to enter the U.S. market are often unprepared or find themselves awash in decisions that they did not imagine confronting. After seeing dozens of these situations, I have compiled a list of risk mitigation factors that help contribute to market entry success.

58. Practical — And Crucial — Actions To Take Now For DSCSA Compliance 6/29/2023

    Serialized data exchange, enhanced verification, and tracing, oh my! Many companies are still unprepared for full DSCSA implementation in November. Is your company one of them? Here are the important actions to take now.

59. 5 Best Practices For Responding To FDA Form 483 Inspection Observations 9/1/2023

    How you respond to FDA Form 483 observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. You don't want that. Follow this 5-step action plan to make sure the findings are properly addressed.

60. What To Consider For A Modular Facility With Closed Processing 1/2/2024

    The emerging trends in the biopharmaceutical industry are driving an even greater need for modular facilities and closed processing. Learn about the progression toward closed processing and more.