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Case Study:

Quality Assurance

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Client:

A mid-size Greater Boston based Gene Therapy organization with a robust CNS & Rare Disease clinical development pipeline.

Key Issues:

Our client was preparing for an EMA certification of their manufacturing process to begin manufacturing materials for distribution to, and use in, the EU. Part of that preparation included updating their Quality Management System (QMS) as well as developing and implementing a GMP readiness program to ensure compliance with EU manufacturing standards. The current QMS was paper-based and they intended to make the transition to automate.

Senior leadership at the client required a flexible yet highly specialized partner to act as a Functional Service Provider. It was essential that this partner be able to meet evolving project deliverables, quickly assemble the necessary resources and integrate them either with their team or as standalone experts. It was also important to our client that they be able to maintain strategic oversight of BioPoint Quality consultants, while delegating tactical tasks to the team.

Solution:

After a thorough needs assessment was complete, BioPoint assigned a dedicated Engagement Manager to tailor an FSP offering that addressed our client’s need for a scalable yet highly specialized service delivery configuration. BioPoint’s Quality SME’s became familiar with our client’s products, commercialization & manufacturing strategies, processes, and external partners, allowing for a more streamlined assembly and deployment of resources as projects dictated.

BioPoint coordinated a comprehensive team of a Quality Management System Lead, GMP Quality Assurance Sr. Director and 3 Quality Specialist. Working both onsite and remotely, the BioPoint team was able to effectively to provide immediate assistance in the following areas over a twelve month period:

    • Quality Management System – BioPoint QMS Lead conduced initial gap analysis of current systems. Following the assessment and in partnership with client stakeholders, the QMS Lead designed, optimized and implemented a new system with the support of one Quality specialist for task execution.

    • GMP Compliance and Inspection Readiness – GMP Quality Director and 2 Quality specialist performed a variety of tasks to prepare for the pending EU inspection, such as SOP writing, CAPA development, mock audits and training of client employees

Conclusion:

By entering into a true partnership via an FSP alliance with its client, BioPoint was able to provide increased control, full transparency of project deliverables and timelines, as well as substantial operational and cost efficiencies. Our client was in a position to address critical business needs and manage workload, while having the ability to more strategically transition to direct internal staff. BioPoint’s consultants remained available to assist with training as new employees were assimilated into the Quality group.