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SPIDER Network for Automation Training

Automated bioprocess test beds will be designed and implemented across three sites. Each test bed will consist of process Sensors and software for Process control, Integration, Data analysis, process Evolution, and Reporting.
Categories
Proteins/ Antibodies
Drug substance
Process control
Talent/ Pipeline development
Project status
100% Completed

Industry Need

There is a need for expertise in automation for operators, technicians and engineers. According to industry automation focus groups working with NCSU and WPI, companies in North Carolina and Massachusetts have a difficult time hiring employees with the desired automation skills, so they have to provide on-the-job training in automation. Typically, that training is supplemented with classroom and online courses offered by a number of professional organizations and training companies, but the content is often very basic and not specific to the biomanufacturing industry, and if hands-on activities are offered, they do not involve bioreactors or other typical biomanufacturing unit operations. 

Solution

The purpose of the SPIDER Network is to provide this workforce training and development in automation related specifically to biomanufacturing. For the SPIDER Network, a variety of automated test beds that represent a sample of typical biomanufacturing unit operations, were designed and implemented. These test beds are available to NIIMBL members to facilitate training and testing. The test beds consist of Sensors and software for Process control, Integration, Data analysis, process Evolution, and Reporting (SPIDER). The test beds allow the SPIDER Network to provide automated equipment and data analysis/reporting capabilities for hands-on activities used in training courses (current and future). The test beds also enable the innovation of new process sensors and manufacturing processes since equipment vendors and biopharmaceutical manufacturers will be able to select the test bed that best approximates their target bioprocess and generate data that facilitate purchase and/or regulatory approval. More importantly, it eliminates the requirement for biopharmaceutical manufacturers to test new sensors or processes in their cGMP facilities or translate results from a vendors’ system. Lastly on top of the available equipment and hardware, the test beds have capabilities to enable innovation of new software for control, integration, data analysis/process evolution, and reporting. Software vendors and biopharmaceutical manufacturers will be able to generate data to ensure robust performance of control systems. In addition, data analysis models can be developed using the test beds and transferred to production systems.

Outputs/Deliverables

  • Test bed equipment covers a range of biomanufacturing unit operations and a variety of control software and hardware
  • Upstream unit operations include: bioreactors (ranging from 2 to 40 L in scale; stainless steel, glass, and single-use vessels), with the capability for fermentation or cell culture (batch or perfusion via ATF), and a range of online and offline sensors/analyzers; automated SIP and CIP skids also available
    • Downstream unit operations include: TFF, centrifuges, chromatography skids
  • 3D scans of all three test bed sites available for viewing
  • Developed automation test beds for utilization in automation training (current/future courses) and to facilitate development of new sensors, software, data analysis, and process modeling
  • Online curriculum developed for hybrid course: “Essentials of Automation for Biomanufacturing”

o  Registration available on IAAE Portal (https://myiaae.org/page/Education)

o  Online curriculum reviewed by industry partners

o  17 Modules are prerequisites for the hands-on course

  • Hands-on curriculum created for hybrid course: “Essentials of Automation for Biomanufacturing”

o  Six students target class size for most hands-on exposure

o  Two-day course offerings after completion of prerequisite modules



Impacts

Skilled workforce in automated bioprocesses enables process efficiency and product consistency

Publications

Additional Project Information (Members Only)

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Project Lead

North Carolina State University

North Carolina State University

Participating Organizations

Commissioning Agents Inc.

Commissioning Agents Inc.

Genentech, Inc.

Genentech, Inc.

International Academy of Automation Engineering

International Academy of Automation Engineering

Massachusetts Life Sciences Center

Massachusetts Life Sciences Center

Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC

University of Maryland College Park

University of Maryland College Park

Worcester Polytechnic Institute

Worcester Polytechnic Institute