Project Example
Monoclonal Antibody Purification Process Optimization
Concuir’s consultants significantly improved the overall equipment effectiveness (OEE) of one client’s large scale monoclonal antibody purification process. We helped our client achieve these feats by addressing O-ring failures in the slurry nozzles, introducing variable height chromatography, and increasing the team’s proficiency in handling columns through training.
All the training we provided enabled our client’s in-house team to pack columns properly and efficiently in a repeatable manner, confidently test column packing quality, perform and interpret height equivalent to a theoretical plate (HETP) and asymmetry calculations, and enforce proper preventative maintenance procedures. The training not only aided in significantly improving OEE, but also reduced their in-house team’s column packing time by 70%, greatly enhancing team efficiency in production.
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More Project Examples by Concuir
Redeveloped Existing CIP Cycles
In order to meet quality and validation requirements, Concuir assessed and subsequently redeveloped a client’s existing cleaning-in-place (CIP) cycle.
FDA 483 Form Remediation
Our client was issued an FDA 483 Form and tasked our team with the challenge to rectify and reform their current company practices.
Tangential Flow Filtration (TFF) Optimization
A pharmaceutical manufacturer tasked Concuir with replacing their current TFF system with one that would provide a cost-savings advantage and still maintain product quality.