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Drug Substance

VirtECS Drug Substance has been designed to handle the full scope of the bulk manufacturing process in an integrated model. From upstream operations including inoculation and scale up to the production bioreactor through harvest and downstream purification, VirtECS permits the user to describe the process at the level of detail that best supports their needs. 

  • Cell Culture
    • Inoculation
    • Seed Reactors
    • Production Bioreactors
    • Harvest
    • Supports connected trains
    • Activity detail [SIP, transfer, growth, etc.]
  • Purification
    • Stages defined for each product
    • Activity detail for each Stage
    • Optional prep ahead target times, max hold times and many other features
  • Solution Prep
    • Media and Buffer
    • Determined by Mass Balance based on consumption specified for Mainline Activities
    • Tank or Bag storage, with each lot and tank managed and tracked
    • Expiry
    • Connectivity constraints
  • CIP
    • Defined by circuits and skids
    • Equipment clean state managed by VirtECS
    • Optional hold time constraints (clean and dirty)
  • Other Features
    • Resource usage
    • WFI consumption and production
    • Maintenance

Because of the unique nature of bulk biopharma production processes, VirtECS Drug Substance is a dedicated application of the more general technology upon which VirtECS is built. For example, the model data specification is designed naturally around the process. Data tables are grouped based on the process area:

  • Upstream
  • Downstream
  • Media
  • Buffer
  • CIP
  • WFI

VirtECS scheduling logic has also been adapted within the VirtECS Drug Substance tools to handle special constraints such as:

  • Material expiry
  • Support solution lot dedication
  • CIP/SIP and clean and dirty hold times
  • No-wait processing

Process Modeling / Capacity Planning / Debottlenecking

The ability of VirtECS Drug Substance to represent all of the important process constraints provides a virtual copy of the plant. This allows for a wide variety of potential uses. For example, the effect of a proposed capital investment in new equipment can be measured quantitatively at no cost by adding the equipment the the virtual plant within VirtECS. This analysis may also bring to attention new scheduling challenges that may occur following the addition of equipment, allowing for greater preparation for any process change.

Some applications of VirtECS include:

  • Run Rate Increase
  • Identify Bottlenecks
  • Create Process Improvement Scenarios
  • Analyze Scenarios to determine Run Rate Improvement
  • Identify bottlenecks in Scenarios and repeat the process
  • Study New Product impact
  • Study Site Shutdown impact
  • Plan for Campaign Changeovers
  • Identify WFI consumption peaks
  • Identify Resource Usage peaks

Finite Scheduling

VirtECS Drug Substance brings several additional features to the challenge of finite scheduling.

Advanced Planning & Scheduling (APS) systems can provide tremendous value:

  • Use computing power to find better schedules
  • Avoid planning errors by automatically enforcing all constraints
  • Reduce manual effort for scheduling
  • Enable faster response to new information (for example, demand changes or process upsets)
  • Provide a repository for process data at the level required for finite scheduling (ERP systems are often NOT sufficient for this)
  • Provide a tool for communication between planners and operators within the context of the schedule

There are some potential hurdles that must be cleared in order to enable the value described above:

  • The tool must be able to find good schedules quickly at the required level of detail. Commercial scale scheduling involves a staggering number of decisions. Too much compromise in detail or optimization in order to facilitate speed prevents capture of the potential value
  • The tool must accommodate user overrides, and further, support them by minimizing the manual effort. A model cannot ever capture all of the immediate information available to planners with enough context to make every desired decision. Recognizing this, the tool must allow the user to intercede when necessary, but streamline as much as possible the user interaction.

Through the flexible modeling schema for biologics, VirtECS permits the process activities to be modeled at the level of detail suitable for communication of the schedule for execution.

VirtECS Drug Substance can update the schedule based on current activity status. The scheduling logic automatically replans the timing of any affected activities. This includes responding to unplanned equipment downtime.

Ad hoc activities that are not part of a specific batch or product recipe (for example, maintenance or engineering activities) may be imported or added manually. VirtECS will automatically adjust the schedule as required.

Users may manually override the schedule using intuitive controls to alter timing, sequence of solutions preps, upstream train selection, or other preferences that are not easily represented in data tables. In each case, VirtECS automatically recomputes the schedule so that any affected activities are rescheduled. This allows the user to override the schedule in the simplest way possible without the burden of making every subsequent adjustment manually.

A frozen window may be specified to prevent VirtECS from re-optimizing activities within the desired time horizon.