Avantor zrychluje výrobu buněčné a genové terapie (C>)
A 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.
Our customer was entering a challenging new production space under stretch timelines with little to no organizational infrastructure to support. We provided the subject matter expertise, project oversight and continued services support to exceed customer goals and leave ongoing services solutions in place that adapt to our customers changing needs.
Avantor 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.
Led by Avantor’s Process Consultants, we brought together six business functions offering their unique expertise to ensure our customer established an efficient production work environment and processes with the right materials, controls and data. Key contributions by each area of our business are illustrated in the table.
Additional support provided by our expanded global Avantor team complemented the four production services segments of Design Stage Consulting, Planning & Material Management, Production Readiness, and Critical Environment and Sanitization.
In 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.
Leveraging our C> expertise, our customer saved three months building their team and eliminated staffing risks associated with acquiring permanent resources before processes and work function requirements were defined. Overall this saved our customer time and costs, allowing them to make better staffing and talent acquisition decisions as internal demands grew.
Lean process design was utilized to minimize steps in material logistics and quality processes, and reduce staffing needed by an estimated 5 employees. Additionally, these processes leveraged several digital integration points and reporting capabilities.
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.
Biopharma, consumable and critical environment product specialists provided turnkey product lists and lean stocking levels supporting our customer’s consumables and manufacturing Bill of Materials. Our single-use team consulted on 47 lower cost sterilized assemblies, projected to save millions of dollars annually while eliminating patient risks. Lean material stocking levels and controlled pre-production kitting/staging and material sterilization were built into sustainable processes to reduce costs from the first production runs.
Finally, our team of four services associates were deployed to execute on the Material Ordering, Material Issuance, Sample Logistics, Production Support Services and other ancillary tasks. Each of these services delivered is performed under the controlled SOP developed by Avantor.