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Consulting - Biotechnology
Aveta has specific expertise in the process, equipment, clean utility systems, sterile environments and GMP operations that relate to biotechnology discovery, development and manufacturing. Aveta’s team include some of the world thought leaders in both upstream and downstream processing as well as the unique supply chain that supports biotechnology. Our holistic approach to the process assists in the selection of the equipment and support systems including the design, qualification, operation, cleaning, cleaning validation, multiproduct challenges, environmental monitoring, preventive maintenance and continuous compliance. Aveta provides consulting to the following:
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Monoclonal Antibodies:
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Diagnostics |
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Biogeneric mAB’s |
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New therapies |
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Vaccines
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Multiple types of live, cloned & dead virus therapies being developed with IP driven delivery systems |
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WHO regulated & qualified vaccine sites (ICH-Q7) |
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Stem Cells
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Develop ties between SF Stem Cell Center & Indian Co’s |
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Development, Scale Up & Tech Transfer
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QbD Process Characterization for Tech Transfer & Scale Up |
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Sterile filling |
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Lyophilization |
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Cell Banking |
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Methods, Cleaning & Process Validation |
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Process Analytical Technology (PAT) |
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Supply Chain / Cold Chain
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Packaging: Primary & Secondary |
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Labeling |
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Storage: Freeze & cold |
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Laboratory / Analytical: R&D, In-process and QC |
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Facilities
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Design assist for GXP Lab, Pilot Plant & Large Scale Mfg |
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Equipment selection & qualification |
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