10 May 2024
Summary of FDA Guidance for Industry: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
On Jan 29th, 2024, the FDA released their Guidance for Industry on Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products. Read on as Aidan Harrington full summary on this guidance and what it means for the manufacturing of CAR T cell products.
24 January 2024
How Edge Computing Supports GMP Data Collection and Reporting
Edge computing will support GMP data collection and reporting due to the need to improve efficiencies and expand production to deliver more drug development and manufacturing services. This need results from the growing novel therapies market and the need to streamline operations to keep up with demand.
24 January 2024
Oligonucleotide Manufacturing Facility Design: Overcoming Unique Challenges
In the ever-evolving world of molecular biology and genetic research, oligonucleotides play a pivotal role in a vast array of applications, from DNA sequencing to gene synthesis and targeted therapy development. Designing oligonucleotide manufacturing facilities is a challenge since flexibility and future scalability need to be accounted for. However, the work is imperative to developing and distributing innovative therapies that can cure diseases previously thought of as uncurable.
28 November 2023
Advantages of Single-Pair Ethernet and IO-Link
Thanks to ever-evolving technologies, managing data is faster, easier to automate, and more accurate than ever. This overview explains how using single-pair Ethernet (SPE) and IO-Link is fueling change in life sciences manufacturing facilities.
14 August 2023
Monoclonal Antibodies Facility Design and Simulation
Designing a robust and cost-efficient monoclonal antibodies (mAbs) manufacturing facility is a significant challenge in the life sciences industry due to the difficulty of forecasting product demand and production. By integrating process simulation, coupled with capital and operating cost estimation, one can benefit from an efficient method of evaluating alternatives to find an optimized design.