Case Study:
Biotech Company Advancing a Phase II Autologous CAR T Program
Redefining Potency Assay Strategy to Enhance Product Development
Challenge
The client, engaged in a Phase II clinical trial for their autologous CAR T therapy, encountered significant challenges with their potency assay. Initially developed during the preclinical phase, the LDH release assay used for product characterization and release was now showing high failure rates due to significant variability in assay readouts. This issue was severely impacting the in-process characterization, product release, and stability program, threatening the progression of their clinical program.
Solution
Cellanalytics Consulting was brought on board to address this critical challenge. Our approach involved:
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Thorough Review and Gap/Risk Assessment: We conducted an in-depth review of the existing potency assay, identifying key gaps and risks associated with the assay’s performance and its impact on the overall product development process.
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MOA-Based Solution Identification: Based on the product’s Mechanism of Action (MOA), we explored multiple potential solutions to address the variability and high failure rate of the potency assay. Our focus was on identifying an option that not only resolved the current issues but also aligned with the client’s long-term product development goals.
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Analytical Test Method Redevelopment: After selecting the most appropriate solution, we partnered with the client to redevelop the analytical test method. This included creating a robust implementation strategy to ensure the new method would meet both the client’s and regulatory expectations.
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Regulatory Alignment and Strategy Development: We guided the client in aligning the new assay with regulatory expectations, particularly focusing on the comparability study strategy. This was essential to minimize potential regulatory gaps and ensure a smooth transition to the new assay.
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CQA Justification and Product Release Specification: In addition, we helped the client develop a strong justification for introducing a new Critical Quality Attribute (CQA) and updating the product release specifications, ensuring the changes were scientifically sound and defensible.
Outcome
Within three months of initiating our services, Cellanalytics Consulting successfully addressed the client’s potency assay challenges. We delivered a new, optimized assay and a comprehensive implementation strategy, significantly reducing assay variability and failure rates. The client was able to proceed with their Phase II program without further delays, with a strengthened position for future regulatory interactions.
Conclusion
This case underscores Cellanalytics Consulting’s capability to rapidly diagnose and resolve complex analytical challenges in CAR T product development. Our expertise in both scientific and regulatory aspects ensures that our clients can navigate obstacles efficiently, keeping their development programs on track.
Case Study:
Major Pharmaceutical Company with multiple Immuno-oncology programs
Enhancing Analytical Test Methods Across Multiple Programs
Challenge
A leading pharmaceutical company engaged Cellanalytics Consulting to review their analytical testing methods comprehensively. The goal was to identify gaps and drive improvements across methods used to characterize drug products in various preclinical and clinical programs. With numerous testing methods, the company needed a strategic approach to ensure each method was optimized and aligned with its products' unique Mechanism of Action (MOA).
Solution
Cellanalytics Consulting undertook a structured and detailed approach to meet the client’s needs:
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Comprehensive Gap Assessment: We conducted an in-depth review of the analytical testing methods across multiple preclinical and clinical programs. This effort resulted in 12 gap assessment reports, each identifying potential pitfalls and areas for improvement within the existing methods.
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MOA-Based Method Updates: Based on the findings from the gap assessments, we updated the test methods, tailoring each one to the specific MOA of the respective drug products. This ensured that the methods were scientifically robust and fit for purpose across different stages of product development.
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Method Testing, Optimization, and Implementation: The revised methods underwent rigorous testing and optimization following the updates. Once validated, these methods were implemented to support the client’s ongoing preclinical and clinical programs, ensuring consistency and reliability in their analytical results.
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Project Management: Given the scope and complexity of the project, we managed the entire process efficiently, coordinating across multiple teams and timelines to ensure timely delivery of the revised methods.
Outcome
The entire project, involving reviewing and improving numerous analytical test methods, was completed within 4.5 months. As a result, the client now has optimized, MOA-aligned analytical methods supporting their drug development programs, reducing risks, and enhancing the reliability of their product characterization.
Conclusion
This case demonstrates Cellanalytics Consulting’s ability to manage large-scale analytical review projects, delivering precise, MOA-based solutions within tight timelines. Our expertise enabled the client to enhance their testing methods, ultimately supporting the successful progression of their drug development programs.
Case Study:
Accelerating GMP Laboratory Buildout for a Startup CDMO
Streamlining Analytical Strategy for a Successful IND Submission
Client
A Startup Company with an Allogeneic CAR T Therapy in Development
Challenge
A biotech startup approached Cellanalytics Consulting for support in planning and executing the buildout of their GMP laboratories, specifically focusing on genomics, cell banking, and flow cytometry facilities. The client needed a comprehensive strategy and efficient execution plan to ensure the laboratories were fully operational within a tight timeline.
Solution
Cellanalytics Consulting provided end-to-end support for the GMP laboratory buildout:
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Strategic Planning and Roadmap Development: We identified the key strategies necessary to establish the GMP laboratories successfully. This included defining the technical requirements, compliance needs, and operational workflows tailored to the client's specific focus areas—genomics, cell banking, and flow cytometry.
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Detailed Planning and Coordination: Once the strategies were in place, we developed a detailed plan to guide the buildout process. This plan outlined the steps to move forward, including timelines, resource allocation, and coordination with builders and other relevant stakeholders.
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Stakeholder Collaboration and Project Management: We collaborated closely with the client, builders, and other stakeholders (IT, QA, etc.) throughout the buildout process. Our role included managing communications, ensuring alignment on project goals, and overseeing the execution of the plan to keep the project on track.
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Lab Setup and Commissioning: The project culminated in the successful setup and commissioning of the GMP laboratories. Within four months of signing the contract, the labs were fully operational, meeting all regulatory requirements, and ready to support the client’s research and development activities.
Outcome
The startup biotech company successfully established its GMP genomics, cell banking, and flow cytometry laboratories within an accelerated timeframe of four months. With Cellanalytics Consulting’s support, the client now has fully commissioned labs that are equipped to advance their cutting-edge research and development.
Conclusion
This case illustrates Cellanalytics Consulting’s ability to deliver complex laboratory buildout projects efficiently and within tight deadlines. Our strategic planning, stakeholder collaboration, and project management expertise ensure clients can achieve their operational goals on time and comply with industry standards.
Case Study:
A Startup Company with an Allogeneic CAR T Therapeutic
Streamlining Analytical Strategy for a Successful IND Submission
Challenge
The client, a startup biotech company, was advancing an allogeneic CAR T therapy in their pipeline and needed expert guidance to develop a robust analytical strategy in support of their Investigational New Drug (IND) submission. With limited internal resources and expertise in analytical development, they sought out Cellanalytics Consulting to navigate the complexities of the regulatory landscape and ensure the success of their IND.
Solution
Cellanalytics Consulting engaged with the client to deliver a comprehensive and targeted analytical strategy. The collaboration included:
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Process Analytical Technology (PAT) Identification: We worked closely with the client to identify the critical PAT necessary to ensure the consistency and quality of the CAR T product.
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Target Product Profile (TPP) Definition: Leveraging our deep expertise, we defined a clear TPP aligned with the product’s Mechanism of Action (MOA) to drive the development of a relevant and effective analytical testing package.
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Analytical Testing Package Development: Guided by the product’s MOA, we generated an analytical testing package tailored to meet the regulatory requirements and support product characterization, release, and stability.
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Technology Transfer: Acting on behalf of the client, we partnered with their chosen Contract Development and Manufacturing Organization (CDMO) to facilitate the seamless transfer of the developed analytical methods, ensuring smooth integration into the CDMO’s processes.
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CDMO Management: Serving as the Subject Matter Expert (SME) in the CDMO laboratory, Cellanalytics Consulting managed the optimization, qualification, and ongoing support of the analytical test methods, further ensuring the product’s characterization and release.
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Stability Program Development: We designed a stability program that adhered to FDA guidelines, ensuring the long-term viability and regulatory compliance of the product.
Outcome
Through our dedicated and integrated approach, Cellanalytics Consulting successfully developed and executed a comprehensive analytical package within just seven months. This swift and efficient process led to a successful IND submission and subsequent clearance, positioning the client to advance their CAR T therapy into clinical trials.
Conclusion
This case highlights how Cellanalytics Consulting's deep expertise in cell and gene therapy, combined with our proactive approach to client collaboration, can accelerate drug development timelines and facilitate successful regulatory submissions
