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Avantor accelerates Cell and Gene Therapy (C>) production
Avantor accelerates Cell and Gene Therapy (C>) productionChallengeA global pharmaceutical company set an ambitious strategic goal of transitioning from Cell and Gene Therapy (C>) concept to full-scale GMP production within a year. Despite the customer’s global recognition in personalized medicine, this was a new segment of production requiring significantly different skills and processes. The current-state processes provided room for optimization. To scale up production processes, the critical environment and process controls needed to be specified. This included specification of: critical materials requirements, PPE and consumables needs, production support and logistics processes, and staffing levels required by functional area. SolutionAvantor recognized the challenge our customer was facing moving from a white space to full scale GMP C> production in less than a year. We formed a cross-functional team to guide our customer through the design-stage projects and production process commissioning. ResultIn this project, Avantor set our Customer Clinical GMP C> Production and Science in motion. We exceeded our customer timelines by an estimated one month and built efficient low-cost processes to meet production goals of 12 patients per month. To further mitigate risks and ensure process continuity, a form-based manual process was developed. This process was leveraged to go live with production on time as some of the customer’s digital systems were not operational to support their ambitious timeline. ChallengeA global pharmaceutical company set an ambitious strategic goal of transitioning from Cell and Gene Therapy (C> concept to full-scale GMP production within a year SolutionAvantor recognized the challenge our customer was facing moving from a white space to full scale GMP C> production in less than a year. ResultWe exceeded our customer timelines by an estimated one month and built efficient low-cost processes to meet production goals of 12 patients per month. Need Help?Avantor Services has the skills, knowledge, and experience to support productivity improvement at your organization. |