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FEATURED EDITORIAL

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Chief Editor Louis Garguilo writes: "For the first time in more than a decade writing this column, I’ll focus on a specific 483 – actually two – received by a CDMO site. It pains me to do so, for a number of reasons. But the overall industry reaction to this specific FDA issuance compels me to take this on." Read about the 482 heard round the world, and what it means for CDMOs, sponsors, and the FDA.

GUEST COLUMNISTS

Key Considerations For Materials And Components Used In CGT Manufacturing
This article sheds light on the complexities and regulatory intricacies of ancillary materials and single-use systems in cell and gene therapy manufacturing.
Automation In The Lab: Lessons From Successes And Setbacks
Real-world examples show that, in some labs, manual screenings disappeared altogether, replaced by automated runs that now cover entire departments.
Defining Strong Program Management In CDMO Partnerships
This first article of a planned three-part series discusses the pitfalls that program managers help sponsor companies avoid, how program managers accelerate timelines or reduce risk, and more.
CGT Success Starts With The First Mile
The so-called "last mile" in cell therapy gets a lot of attention. What about the first mile, the journey cells take between the donor and the manufacturing site?
Can CHO Bioreactors Be Used For Plant-Based Protein Production?
The moss Physcomitrium patens is especially good at producing glycoproteins. Established technology and prior knowledge are helping one company develop new therapies with it.
How To Grow CHO Cells Without Cysteine, Tyrosine Feeds
Researchers at Pfizer are developing a cell line that synthesizes these amino acids autonomously, which could reduce costs and increase stability.
Making The Leap To Smart Bioprocessing
A European consortium achieved greater T cell expansion compared to baseline conditions using real-time process monitoring and control.
Unlocking Method Insights For Novel Engineered AAV Capsids
Microfluidic platforms, such as labchip, are widely used for assessing wild type capsids. Now, engineered capsids are challenging these established workflows.

PHARMA OUTSOURCING WHITE PAPERS

Quality By Design (QbD) For Biologics From A CDMO Perspective
Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

Innovation In Filtration
Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
The Problem With Construction Quality
Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.
Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements
Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.
Enabling Digital Twins With Computational Fluid Dynamics Modeling
Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.
Best Practices For Regulatory Excellence In Clinical Research
Observe how GCLP can integrate ethical and technical standards to ensure reliable, compliant clinical trial data and optimize laboratory operations across sponsors, CROs, and partners.