After assuring clinical validity, finding and managing the right contract manufacturing organizations (CMOs)/contract development manufacturing organizations (CDMOs) is a Sponsor's major concern when pondering the future of their products. Given the dramatic increase in cell and gene therapy research and funding over the past four years, there is a surge in demand for new cell and gene CMO/CDMO capacity needed to get products from bench to commercial scale. Sponsors must improve their methods for finding and managing these assets.
Growth in biotechnology, an increasing emphasis on science-based technology, and the emergence of innovative virtual startups have led to a great variety of CMOs that offer competitive pricing and highly specialized services. Because of this, it is important that Sponsors use a methodical approach to selecting a manufacturing partner, ensuring that the CMO selected fits your company's business model.
CMO selection is one of the most critical decisions made by companies that have limited internal resources dedicated to production, testing, and control of pharmaceutical products. We take a standardized systematic approach to CMO selection, looking at using a completely outsourced model for manufacturing, (scale) development, and testing of your product within the required regulatory and quality framework. This process requires extensive research, planning, and coordination. ProPharma Group has developed a CMO Compass® process that helps point companies in the right direction and provides a roadmap for effective selection and integration.
The first step is to map the process that will be transferred with applicable boundaries and conditions. Our team of experts start with the finished product’s critical quality attributes, including storage and distribution, and work backwards to the raw materials. A process map should include any equipment (such as cell washer, bioreactor, freezer), durations, manual operations, storage conditions, raw materials (vectors, media, cell banks), and related manufacturing, storage, and transport conditions.
Using the map developed previously, the next step is to meet with the key stakeholders to document a list of expectations based on the process being transferred as a survey-assessment. Expectations fall into five categories: (1) Capability, (2) Compliance, (3) Cost, (4) Customer service, and (4) Quality. Each of the categories is broken down into their basic cell and gene components to ensure each functional area requirements are documented to avoid wasted effort. Some steps may still be in development phase, so the expected outcome of the related step is also documented.
The assessment is weighted based on a scale ranging from one to ten – one being the items that are must have criteria and ten being the items that are considered nice to have (because there is never a perfect CDMO/CMO). ProPharma Group has been fine tuning the cell and gene therapy CMO/CDMO survey tool to ensure appropriate weighting and quick analysis. Results are summarized using a series of spider diagrams to help stakeholders understand the risks, remediation requirements, and finally the appropriate choice.
ProPharma Group developed the CMO Compass® software tool which allows us to quickly identify the list of companies with the capability to perform the work based upon cell and gene capabilities (current and planned). These include:
The next step is to connect with the individual CMO/CDMO teams with a scrubbed version of the process flow chart and the list of expectations. The important information from the scrubbed data is the type of process (Transduction, Somatic, Germline, etc.), number of steps, timing, sequence, equipment, and conditions. The advantage of utilizing third party to do this is that it allows the Sponsor to remain anonymous, which is more important today than ever because:
When working with ProPharma Group, our cell and gene therapy experts will schedule meetings, work out the high-level details, and find the information you need make informed decisions.
The final step is to create a detailed report reviewing the CMO/CDMO’s compliance history, inspection history, quality systems, equipment and personnel capabilities, available capacity including normal lead times, and cost structures. The report will compare the different CMO/CDMOs against the Sponsor’s expectations.
Our report serves two purposes; first the documented report ensures that the selection was made for the right reasons, and second the report identifies the weaknesses of the selected CMO/CDMO for remediation efforts during the technology transfer process.
Are you in the process of developing a cell and gene therapy product? Regardless of where you are in the development lifecycle or what your current needs are, we have the skills, capabilities, and expertise you need on your side. Interested in learning more about how we can help you identify and select the best contract manufacturing organization/contract development manufacturing organization for your needs? Contact us today to learn more.
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