Development

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Development

Navigating the Regulatory Landscape in Cell-Based Operations

In the intricate world of cell-based R&D, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP) laboratories, the stakes couldn't be higher—pioneering research and life-saving therapeutics stand as the pillar of achievements. Yet, the stakes are equally high in the realm of regulatory compliance. Stringent standards such as 21 CFR Part 11, Annex 11, ISO 27001, and GAMP 5, 2 ed. are not just demanding; they're the prerequisites for scientific veracity and patient safety.

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Must Read Articles

Navigating the Regulatory Landscape in Cell-Based Operations

In the intricate world of cell-based R&D, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP) laboratories, the stakes couldn't be higher—pioneering research and life-saving therapeutics stand as the pillar of achievements. Yet, the stakes are equally high in the realm of regulatory compliance. Stringent standards such as 21 CFR Part 11, Annex 11, ISO 27001, and GAMP 5, 2 ed. are not just demanding; they're the prerequisites for scientific veracity and patient safety.

...Read more
Ensuring Traceability and Transparency in Cell Culture through User-Traceable and Time-Stamped Notes

In the intricate world of cell-based research, documentation serves as the reliable, indisputable chronicle of a lab's endeavors. A well-documented process is akin to a map that helps researchers retrace their steps or paves the way for others to follow, ensuring the solidity of scientific breakthroughs

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Development
10/18/23
Training

Whether it’s learning how to edit genes, culture cells, or handle lab equipment, the next generation of lab technicians must be properly trained in conducting cell-based operations, so that they can enter the workforce and contribute to your organization with confidence.

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Development
10/25/23
Tech Transferability

When scaling from research to manufacturing, or passing down academic research from one group to another, enormous amounts of insights and findings must be shared without any data leakage– since even the smallest oversight could lead to a detrimental loss of science.

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Development
10/27/23
Fixing the Reproducibility Problem: Why Laboratories Need Traceability of Data and Processes

Cell culture labs today are struggling to handle intricate data streams produced from increasingly complex experimentation. The result: lab results that cannot be reproduced successfully.

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