Cell line validation has been under a bright spotlight since evidence emerged of widespread misidentification and contamination of cell lines, including those used in preclinical research and cited in ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...

The track by which API manufacturing processes are prepared for commercial use is comparable to overlapping integrative process evaluations at commercial scale. This ensures the process is ...

Companies choose manufacturing processes -- such as job order, batch process, assembly line and continuous process -- based in part on the level of product individualization allowed. Manufacturers use ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

The pultrusion line and the dedicated production hall fulfill stringent requirements in terms of cleanliness, manufacturing process validation and quality control. Both assets are qualified for ...

SAN FRANCISCO--(BUSINESS WIRE)--ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), has acquired Portugal-based 4Tune Engineering (4TE), a leader in ...

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and ...