Re:Build Optimation partners with pharmaceutical and biotech manufacturers to provide custom-engineered solutions for process scale up, systems design, fabrication, installation, and integration. Our expertise in skid-based systems, process optimization, and site upgrades ensures that clients can meet stringent regulatory requirements while maintaining high efficiency and precision in production.
From clinical scale (Phase 2) through full-scale manufacturing, we support pharmaceutical companies, generics manufacturers, and startups bringing drug production back to the U.S. With a focus on fast-track delivery, safety compliance, and cutting-edge process solutions, Re:Build Optimation enables seamless scale-up and optimization in pharma production.
We provide full-service design, fabrication, installation, and optimization of process systems, helping companies maintain compliance, improve efficiency, and accelerate production timelines.
1. Process Systems
With expertise in custom-engineered process systems, our team supports pharmaceutical and biotech manufacturing at all scales of production. From early-phase clinical trials to full-scale commercial manufacturing, our solutions ensure precise control, regulatory compliance, and optimal efficiency.
Our systems ensure precise ingredient incorporation, emulsification, and homogenization for consistent batch quality.
We provide jacketed tanks, heat exchangers, and cooling loops for precise temperature control.
Our volumetric and gravimetric dosing systems ensure accurate formulations with minimal waste.
We offer membrane, depth, and centrifugal filtration for purifying APIs and capturing solvents.
We specify, procure, and integrate spray, vacuum, and fluid bed dryers with our skid systems for seamless process compatibility.
Custom-engineered pressure vessels, storage tanks, and process containers, including design, fabrication, refurbishment, and compliance assurance for optimized process performance.
We procure and integrate reactors for precise chemical synthesis, crystallization, fermentation, and bioprocessing in high-purity production.
Scrubbers and effluent treatment systems for environmental controls.
2. Skid-Based Systems
We deliver turnkey design, fabrication, and integration of process skids, delivering modular, pre-engineered solutions that enhance efficiency and compliance in pharmaceutical and biotech manufacturing. Our custom skids streamline installation, reduce downtime, and ensure seamless process integration.
Skid-based solutions for mixing, heating/cooling, filtration, process monitoring.
Custom automated cleaning and sterilization systems designed for customer specific processes.
Precision-engineered solutions for accurate ingredient addition.
Integrated systems for real-time tracking and control of solvent levels in critical production areas.
Custom-engineered solutions for formulating and precisely transferring solutions to downstream processes, ensuring seamless integration and efficiency.
3. System Modifications and Upgrades
Specializing in redesigning and manufacturing legacy mechanical components, our engineers extend equipment life, improve performance, and eliminate costly revalidation issues. Custom fabrication capabilities ensure precise, high-quality replacements that seamlessly integrate into existing systems.
Engineered solutions for efficient thermal transfer and optimized process performance.
Precision-machined valve components to ensure reliable flow control and system efficiency.
Design, integration, and optimization of control systems to enhance process automation, monitoring, and precision.
Implementation of safety controls and monitoring systems to detect hazards, ensure compliance, and mitigate operational risks.
4. Site Upgrades & Equipment Installation
To support pharmaceutical and biotech manufacturers in upgrading facilities, we provide turnkey installation services that minimize downtime and streamline new equipment integration. Our team designs, fabricates, assembles, and installs process systems, utilities, and control systems, ensuring seamless implementation and validation through Site Acceptance Testing (SAT) to optimize performance and maintain regulatory compliance.
Custom automation solutions, including PLC, SCADA, and DCS-based controls for precision and efficiency.
Design, installation, and optimization of clean steam, WFI (Water for Injection), condensate return, drainage, Nitrogen, Argon, compressed air utilities, etc.
Design, fabrication, and installation of advanced control panels for improved monitoring, process control, process automation, alarming, and mitigation.
Seamless deployment of bioreactors, storage tanks, and process skids built to meet industry regulations.
We work across multiple sectors within pharmaceutical and biotech manufacturing, including:
From design to full-scale production, Re:Build Optimation designs and builds end-to-end manufacturing solutions for pharmaceutical and biotech companies. We specialize in system design, automation, and custom equipment fabrication, ensuring seamless execution from concept to commissioning. Whether you need a new system, process skid, or facility expansion, we engineer, fabricate, and install solutions tailored to your product and regulatory needs.
Regulatory compliance and risk mitigation are critical in pharmaceutical manufacturing, where cGMP standards must be met at every stage of production. Our team ensures that all process equipment, automation systems, and site installations adhere to the latest regulatory requirements while maintaining efficient project timelines.
With a growing focus on reshoring pharmaceutical manufacturing, companies need a partner that understands installation codes, and domestic production incentives. Re:Build Optimation supports pharmaceutical and biotech companies in navigating jurisdictional regulations, and implementing U.S.-based production facilities to enhance supply chain resilience.
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