CMC can make or break a CGT approval, as DHC’s experts know well. Time spent on getting CMC development right will nearly always pay dividends by streamlining next steps towards regulatory approval and commercialization.
Former FDA Commissioner Scott Gottleib said the following when addressing ARM's annual board meeting in 2018, "In contrast to traditional drug review, where 80 percent of the review is focused on the clinical portion of that process, and maybe 20 percent is focused on the product issues, I’d say that this general principal is almost completely inverted when it comes to cell and gene therapy."
Our CMC Service Domain comprises all service offerings previously listed under the Core Capabilities of Product & Process Development, Analytical Development, Device Development, Facilities, Manufacturing, & Compliance, and Project & Program Management.
We leverage the multi-disciplinary expertise of our team to help you navigate and overcome various challenges at all stages of development. Our experts can support you with failure analysis and mitigation of manufacturing processes and analytical methods/assays, development and execution of comparability studies, analytical method development, transfer, qualification and validation support, process and method evaluation and codification, as well as support with NGS studies and off-target analyses.
We leverage the multi-disciplinary expertise of our team to help you effectively and expeditiously address operational challenges and bottlenecks. We can support you with remediation of manufacturing and testing failures at CDMO’s/CRO’s/CTO’s, help you with facility design and quantitative capacity planning, perform training and workforce development activities, support you with various aspect of project management, or provide interim functional leadership until you are able to identify and hire an internal candidate for the position.
Our team can provide support throughout the full lifecycle of device development: URS definition, existing device landscape analysis, device concept design, engineering firm search and selection, prototype development project management and oversight, as well as the authorship of Design History Files (DHFs), Device Master Files or Device Master Records (known as MAFs or DMRs, respectively), and any other required documentation for your device.
We use our proprietary CDMO database and established methodologies to help you identify prospective CDMO partners based on your unique needs, develop and execute the selection process, support you through vendor audits and contract negotiations, design and manage the technology transfer process, and oversee the subsequent technology implementation and manufacturing activities at the new manufacturing site.
We leverage the multi-disciplinary expertise of our team to support you throughout the full lifecycle of your product development through a gap analysis-driven establishment of your Product Development Plan, from FIH studies to Commercial stage (“roadmap to BLA”), inclusive of QTPP definition, Process Development Plan, Analytical Development Plan, raw materials assessment and selection.
Our extensive experience gained from working on over 1,000 projects at all stages of development allow us to effectively support you in the establishment of your overarching CMC strategy with activities such as portfolio prioritization, manufacturing strategy and capacity planning through quantitative modeling, and supply chain strategy establishment.