Our Story

The Early Days

  • The 80’s: Finding Direction
    Dr. Fernando Muzzio learned about continuous manufacturing as an undergraduate in chemical engineering, and again as a graduate student working in petroleum refining with a continuous process. At the time, continuous processes existed outside the pharmaceutical industry and were known to make many product units as uniform as possible with a highly reliable manufacturing approach and process control.

  • The 90’s and the early 00’s: Pushing Ahead
    In 1998, responding to a long-standing need of the pharmaceutical industry to address blend homogeneity challenges, Dr. Muzzio proposed continuous processing systems that prevented blend segregation. At the time, the risk-averse, batch-based pharmaceutical industry considered continuous processes too radical to gain regulatory approval.

  • 2003: FDA Interest
    Continuous manufacturing was endorsed by US FDA representative Dr. Janet Woodcock at a CAMP Consortium meeting, and a connection was made. Soon Dr. Muzzio presented continuous processing concepts to the PAT team of the FDA focusing on a continuous line that integrated PAT sensors in closed loop control. CDER leadership  responded enthusiastically. Soon thereafter, CM was listed in the 2004 PAT guidance as an example of PAT application.

  • 2004 to 2006: Research and Progress
    In 2004, Dr. Muzzio created the Rutgers Continuous Manufacturing Consortium with participants from Merck & Co., Pfizer, Apotex, and GEA. Then in 2006, the National Science Foundation (NSF) awarded the Rutgers team $40M to establish C-SOPS; researchers from Purdue University, the University of Puerto Rico, and the New Jersey Institute of Technology, and more than 60 companies joined the C-SOPS team to create a new CM platform.

2008 – The CSOPS team at Rutgers achieved successful integration of distributed closed-loop control in a direct compression system.
2009 – Dr. Muzzio and Dr. Ierapetritou implemented and demonstrated an integrated flowsheet dynamic model of a continuous system.
2012 – Dr. Muzzio articulated material property databases for surrogate selection and material-property-dependent process models
2013 – C-SOPS demonstrated RTD-based control.
2014 – During a visit to Fette, Germany, Dr. Muzzio unveiled a standardized 12-step implementation approach to continuous processing models. Later that year, Janssen-funded advanced manufacturing partnership resulted in project Inspire, and the Consigma modeling project.

2015: Critical Progress
Acumen Biopharma (owned and managed by Daisy Rivera Muzzio) launched Integra CMS, a New-Jersey based, wholly owned subsidiary focused on supporting implementation of continuous manufacturing processes across North America, Europe, and Asia. Integra CMS received a know-how licence and executed a master services agreement with Rutgers University to develop, practice, and commercialize C-SOPS knowledge and utilize C-SOPS resources.

2016 – A year of accelerated development:

  • Dr. Muzzio named Inventor of the Year 2016 by the New Jersey Inventors Hall of Fame.
  • C-SOPS participated in multiple research and development programs, including:
    US FDA-funded research and training programs drafted to cover material properties, process control, process modeling.
    USP-funded partnership on development of continuous manufacturing standards.
  • C-SOPS progress was recognized as the first example of successful federal investment in continuous manufacturing by the Office of Science and Technology of the White House.

2017 – A team dedicated to quality:

  • Integra CMS team focused on integrating real-time quality assurance.
  • Integra CMS launched major collaborations with Steer in India.

2018 – Partnering to advance continuous processing:

  • GSK-launched an advanced manufacturing partnership with C-SOPS.
  • Dr. Muzzio and C-SOPS received Chairman award from the Research and Development Council of New Jersey.
  • Integra CMS launched major collaborations with Infinitus in China.