PAT & QbD consultancy services

PAT & QbD consultancy services
KYMOS offers PAT and QbD Consultancy Services
Cristina Fernandez, PhD, has joined KYMOS to reinforce its offer of PAT & QbD services mainly for biopharmaceuticals and fine chemicals. KYMOS provides full support from feasibility studies to real time batch release, including regulatory assistance.
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PAT and QbD services
Specifically chemometrics and statistics for NIR and RAMAN spectrometry
Spectroscopic techniques (e.g. NIR, RAMAN, UV) and data analysis tools are key to develop QbD strategies & PAT methodologies. Their implementation decrease significantly the need for sampling and classical analyses, reducing time and costs, increasing safety and process understanding and improving product quality (less batch rejections). Real time process data enables scale up, control of undesired materials and has automation and real time release possibilities. Our success stories in this field include the development and implementation of raw materials/API libraries for identification and qualification, quantification of API on drug products, process deviations trouble-shooting and determination of physical properties (particle size, homogeneity, moisture, etc.), among others. We also offer support to regulatory affairs departments, specific training adapted to the customer needs and assistance in suitability studies.
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QbD is key to develop chemical synthesis and manufacturing processes to ensure product quality through process understanding, in process control and continuous improvement. Implementing QbD strategies is possible to identify critical quality attributes, critical process parameters and sources of variability. The full control of manufacturing processes ensures consistent quality over time.
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On-line monitoring is required to analyse, and control manufacturing processes through real time measurements of critical quality and performance attributes of raw and in-process materials with the goal of ensuring final product quality and improve process robustness. The final aim is to enable partial or total real time batch release.
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Cristina Fernández joins KYMOS as PAT and Chemometrics Specialist
Cristina is an outstanding professional nominated as PAT and Chemometrics Specialist at KYMOS. Cristina is a chemometrician by background and has a previous experience in a global pharmaceutical group UK based. She is specialized in the improvement of chemical synthesis of pharmaceutical active ingredients. Contact her:, +34 935 481 848.
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Parc Tecnològic del Vallès

Ronda Can Fatjó, 7B

08290 Cerdanyola del Vallès

Barcelona. Spain





+34 935 481 848

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