Gap Closures / Development
At RR-BPC we specialize in system development with the art of biologics in mind - subject matter experts are core decision makers for bioprocess manufacturing until full automation is in place and our goal is stable and reproducible production with human oversight and control until characterization and optimization enable automation.
Prior Engagements
Engineered Tissues, Cellular Therapies, Gene Therapy, Tissue Transplants
What We’re Bringing to the Table:
The transition from bench to bedside is only the first of several paradigm shifts in the growth of any business dependent on the development of reliable and responsible bioprocess manufacturing. RedRock has specialized in what our team knows best, the transition from bench to First in Man through to your successful pivotal trial Phase Appropriate GMP, Quality by Design and Lean Manufacturing principles are framework RedRock applies to your process and derisk your path to BLA.
Gap Closures / Development
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QUALITY SYSTEMS
Prior to human trials, regulatory ambiguity is a barrier to the introduction of basic controls. We are available to streamline the introduction of basic or phase-appropriate controls to ensure quality without consuming your runway, and provide support for SOP/record development. Once we know what you need, we can help you build and activate.
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ENVIRONMENTAL MONITORING
Environmental controls are a perfect environment for statistical process control, and the vast majority or early phase systems can be managed in house, resulting in substantial savings, but more importantly, better control and faster response. You’re always better when you’re in control and we can give you the tools. Our biofilm specialists can help identify high risk areas and steps in your process.
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GMP MANUFACTURING
Developing the systems of manufacture and eliminating points of instability or regulatory concern cannot be under-resourced. Lean on our scale up and tech transfer expertise to bring some extra horsepower to the table when needed. We live in a time of rapid change, for better or worse.
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ASSET AND FACILITY MANAGEMENT
A reliable system for tracking, clear workflows and defined accountabilities will keep your assets in use and reduce burnout of this critical team during times of rapid change. We can help you get your house in order.
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PURCHASING AND INVENTORY CONTROL
Has your gap analysis revealed that you’re missing 3-way verification of materials, or that your team doesn’t have a process for determining exactly where materials should be quarantined? We’ve got the time to save you time with a turnkey solution to ensuring your materials are received on time, stored safely and monitored.
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CMC OPERATIONS
A great Ops Lead and a comprehensive system for monitoring your critical equipment is a game changer, and we can help operationalize this system or design a compliant paper-based system that can keep you operating . Let us support you in setting up alarm management and equipment performance management systems so your team can focus on your product
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Basic Manufacturing KPI Development in Bioprocess Manufacturing: Schedule Attainment, Efficiency, and Quality
Dr. Irwin is a translational medicine veteran who has been designing, installing, and operating manufacturing systems over 20 years.
Using a Quality by Design and LEan Six Sigma approach to cellular therapies, tissue isolates, and engineered tissues will expedite development and eliminate errors.
Dr. Irwin specializes in the strategic deployment of phase-appropriate GMP and enabling small teams to stay small, agile, and dangerous.
Let’s work together
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