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Cell & Gene Therapy Cell & Gene Therapy
Cellular and Gene therapies are rewriting the boundaries of biotechnology.

Cellular and Gene therapies are rewriting the boundaries of biotechnology.

With new frontiers come new challenges: scaling out of autologous cell therapies, manufacturing vectors in high volume and right-sizing complex data collection systems for organizations of all sizes.

Control Southern can help you lower costs, reduce time to market and implement quality by design into your existing and planned systems. 

At Control Southern, we have the right technology, consultants, and expertise to help you create the right solutions!
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Equipment Management
  • Equipment Management
  • Real Time Data Visualization
  • Calibration & Maintenance
Orchestrate Data Collection (IIoT)
Unify Disparate Systems
  • Identify & Track Critical Parameters
  • Integrate Diverse Equipment
  • Standardize Data Formats
Collect & Contextualize Data
Tech Transfer
  • Reduce Time to Market
  • Eliminate Bottlenecks
  • Design Scalable Architectures
Scale Up/Out
Process Control & Analytics
  • Design Control Strategies
  • Implement Automation and PAT Solutions
  • Develop Process Models
  • Control CQAs
  • Assure Data Integrity
Automate the Process & Manage Data
Electronic Workflows
  • Organize Tasks & Events
  • Schedule Activities & View Status
  • Improve Workflows
  • Electronic Batch Records (EBR)
  • Eliminate Manual Logs & Work Instructions
Collect & Manage Manual Data
Supply Chain
  • Manage Inventory & Logistics
  • Lot & Batch Tracking
  • Patient Genealogy
  • Review by Exception & Real Time Release
  • Streamlined Release Reports
Control Chain of Identity
Chain of identity and chain of custody are critical for guaranteeing lifesaving medications are produced with no patient risk and delivered on-time to the correct patient. From sample receipt to testing to delivery, steps in your process should be electronically documented and verified. Electronic CoI/CoC workflows ensure materials are tracked and documented in real time as a batch moves from patient cell delivery to cell expansion through transformation to final formulation and distribution. Emerson solutions help guarantee that your process is accurately documented and verified, helping the right people do the right operations with the right materials on the right batch.

Learn More about electronic document solutions
Your assets are your patients’ lifeline – your organization depends on proactive measures to keep your equipment in optimal operating shape. Maintaining top quartile performance requires a predictive maintenance program crafted to fit your facility precisely and having your team access the information in a quickly digestible fashion. Preventing problems before they arise helps avoid unplanned downtime that eats into maintenance budgets and disrupts carefully curated supply chains. Emerson offers the mix of asset management and condition monitoring specifically suited to cell therapy facilities, ensuring your product makes it to the patient’s bedside without delay.

Learn More about Reliability Solutions
Your process is unique – your manufacturing requirements are too. The next generation of therapies doesn’t have a roadmap to market, organizations are blazing new trails to get there. Equipment manufacturers don’t yet have an off the shelf solution for your biomanufacturing needs, but Control Southern's single use product portfolio allows for flexibility and quality for once off projects.

Learn More about Flexible Automation
Critical to success for a commercial cell or gene therapy product, scheduling activities and batches is a challenging and costly endeavor. Gathering all information on the manufacturing floor into a single source of truth can be accomplished automagically, drawing information and status directly into manufacturing, training and maintenance systems. Reduce total hands on time per batch, while maintaining an always feasible schedule for batch manufacturing. Emerson’s Bio-G helps coordinate production, maintenance and training while accurately forecasting manufacturing output.

Learn More about Real Time Modeling