White Paper: Bringing GMP Compliance into Cell and Gene Therapy Production
Bringing GMP Compliance into Cell and Gene Therapy Production
This comprehensive guide is designed to support CDMOs specialising in cell and gene therapies by providing essential insights into achieving Good Manufacturing Practice (GMP) compliance. As the industry rapidly evolves from laboratory settings to commercial production, understanding the regulatory requirements and the necessary equipment features is crucial for ensuring the highest standards of safety and efficacy.
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Key benefits of cryoFIL®
Maximise cell yield through minimised hold-up volume, intelligent closed loop filling with 100% weight verification and zero-loss priming sequence.
Automated cryovial placement into racks for fast transfer to your existing controlled rate freezer (CRF).
Accurate and repeatable filling with a high precision low-shear peristaltic pump.
Ensure security of your samples with precision control of cap tightening torque.
Highest standards of hygienic design, including ‘first air’ principles and minimised vial open time.
Compact footprint - integrated within a 5' BSC. Optional integration with other BSCs or isolators - contact us to discuss
Supports the majority of cryovials, both internally and externally threaded variants with simple change parts between variants.
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