Industry Insights

81. Understanding Sterile Filtration And Importance Of Prefiltration 4/27/2022

    Learn more on the importance of sterile filtration and how sterile filters are validated by the manufacturer and review the process and value of selecting the best prefilter to improve final sterile filtration performance.

82. Medical Devices Regulatory Priorities In India 5/14/2018

    India’s Medical Device Rules, 2017 have many attractive features that encourage the medical device sector in India. They have been formulated to promote domestic manufacturing and to regulate import and manufacturing in the region. This article examines some of the regulation’s key points to provide a better understanding of its impacts.

83. Getting A Handle On Clinical Trial Costs 4/25/2019

    Recently, clinical trials have become very complex affairs, especially for small and medium biotech companies. There are many factors behind this, including, but not limited to, increased costs and regulatory requirements. According to Tomasz Sablinski, CEO at Transparency Life Sciences, the cost of clinical trials increased by around 100 percent from 2008 to 2019. A study published in JAMA Internal Medicine in 2018 found that out of 138 pivotal trials assessing 59 new therapies that received FDA approval between 2015 and 2016, there was a more than 100-fold difference in the costs of clinical trials.

84. Accelerate The Start Of Your Outsourced Pharmaceutical Project

    In Part 1 of this series, we explore the best way to streamline the initial stages of forging a relationship between the drug maker and a contract development & manufacturing organization (CDMO).

85. Gene Therapies: A Guide To Aseptic Single-Use Connectors 3/9/2022

    It's important to frequently evaluate your manufacturing process, gauging if improvements can be made. Learn how aseptic connections can impact your efficiency and speed as you continue to scale-up.

86. Using Production And Postmarket Data To Validate FMEA Assumptions 1/15/2021

    One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.

87. Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up 12/5/2025

    Computational success is no stand-in for therapeutic readiness. Innovators must learn to discern between models rooted in science and those that speculate.

88. What's The Difference When It Comes To Managing Quality? 8/27/2021

    QA and QC are not identical or interchangeable, but you’re likely to have peers who don’t understand the distinctions between them. Read this blog to help such individuals solve the mystery behind these frequently conflated quality functions.

89. Unlocking The Full Potential Of Genomic Medicine 6/1/2022

    There are two key challenges to realizing the potential of genomic medicines, but potential technological solutions are on the horizon, and we examine each.

90. Sterile Injectables: Why Innovation Matters More Than Ever 1/15/2026

    New technologies and regulatory changes are shaping safer, more efficient filling processes. Discover why innovation is key to protecting patients and advancing therapies.