Industry Insights

71. Advanced Analytics For Process Control Engineers 12/20/2022

    Learn about contextualization capabilities that were purposely built for control engineers to help with identifying and analyzing transient, non-steady modes of operation.

72. New DSCSA Guidance Details Layers Of Verification System Requirements 2/15/2024

    A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.

73. How To Select The Appropriate Flooring System For Your GMP Facility

    By Eric Bohn, Partner, Jacobs Wyper Architects

    In today’s construction industry, there is an overabundance of flooring materials available for installation in your facility. The quality, cost, and functionality of these options vary wildly. You can run down to your local home improvement store and purchase vinyl tile for less than $1/square foot or spend over $20/square foot for specialty products of exceptional quality and durability. With so many choices, it is not always easy to know which flooring system is appropriate for your cGMP facility. 

74. Tips & Tricks For Risk Facilitators Conducting Remote Sessions 12/8/2021

    When the pandemic hit, the tools normally available to a risk facilitator during a working session were gone. This article presents some of the challenges encountered and learnings from that adjustment and recommends tips for risk facilitators in the hybrid work environment that has emerged from the pandemic.

75. GMP Plant Uniform Lockers And Procedures: Best Practices 4/22/2024

    As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.

76. 9 Essential Oligosynthesis Component Needs 4/16/2025

    Meeting the growing need for oligonucleotides means having the right tools. Learn about the nine indispensable components, such as synthesis columns and C&D systems, for your facility.

77. 3 Problems To Avoid When Establishing A Quality System 10/23/2012

    For some products on the market, quality is a luxury or an option. However, when your product is under the FDA umbrella, quality is required by law if you want to do business in the United States. In the pharmaceutical industry, the customers we serve have very precise expectations when it comes to product quality — nothing but the best, with the highest standards of production and manufacturing. Because the end product affects people's lives, pharma companies aren’t afraid to pay whatever it takes to achieve quality.

78. Calculating The Probability Of Passing The USP Dissolution Test 1/9/2023

    Dissolution tests are performed during drug manufacturing to ensure that the drug product meets the standards specified in the United States Pharmacopoeia (USP). This article calculates the probability of passing the USP dissolution test using Microsoft Excel, and it can be modified for any combination of Q, mean, and standard deviations.

79. Driving Change of Implementing In-Line Conditioning 2/1/2018

    The large buffer volumes required for biomanufacturing can be a bottleneck, especially when scaling up. Just-in-time buffer preparation can be the solution.

80. Overcoming The Challenges Of Cell Therapy Manufacturing 10/17/2022

    Learn more about how allogeneic approaches have the power to revolutionize the use of CAR T-cell therapies.