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Facility of the Future
Jeff Odum, CPIP shares his expertise in the white paper, “Biopharmaceutical Manufacturing Facility of the Future".
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Biomanufacturing: Taking Technology to Production
With technical expertise spanning R&D to pilot-scale and large-scale production, our team knows the technology, trends and regulatory environment to successfully deliver your project. Our unique approach and technical expertise enables us to significantly improve operational capabilities, throughput and process control, optimize cost and minimize risk.
We have working experience with a wide range of products including vaccines, protein therapeutics, whole cell products, industrial enzymes, vitamins, organic acids, amino acids, DNA products and flu egg production.
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Several examples of successfully completed projects include Installation of Cell Culture Reactors; EPCMV for a 15,000sf Clinical Supplies Manufacturing/Filling Technology Upgrade; EPCMV for a 75,000sf Greenfield Manufacturing Facility for Cell Culture Bioproduction; Fast-track EPCM Modification of Existing Large Scale Cell Culture (LSCC) process systems; Design, Engineering and Construction support for a Flu Adjuvant Manufacturing site; H1N1 Vaccine Manufacturer/Logistics Resource Planning and Scheduling to maximize efficiency and a Greenfield vaccine manufacturing facility using roller bottle technology.
For a recent client, we provided feasibility and engineering services to modify an existing large-scale CMO Stainless Steel (SS) facility to implement Single-use (SU) Technology and equipment-based processes. Our team of NextGen experts identified location options for new SU operations, including existing production space to a variety of warehouse, office and maintenance areas. To meet client short term, production and capital strategies, IPS adapted existing production areas for operating Single-use Bioreactors (SUBs) within GMP production areas. We also evaluated SU downstream processes and adapted to operate in a variety of configurations within current manufacturing spaces and optimized SU integration with “out-of-the-box” ideas and approaches.
We partnered with our client on a 250,000sf Large-Scale Manufacturing Upgrade to increase titer capabilities and increase overall efficiencies with maximized throughput. This project was awarded 2010 ISPE Facility of the Year Award for Operational Excellence.
Expert Insight
"On the Floor wtih Chuck Stock at INTERPHEX 2013: The IPS Biomanufacturing Tour", Chuck Stock, CxA, PHARMAevolution, April 2013
"On the floor at INTERPHEX 2013: The Biomanufacturing Tour", Chuck Stock, CxA, PharmaEvolution, May 2, 2013
Podcast: "Biomanufacturing in the 4th Decade", Jeff Odum, CPIP, April 2013
Podcast: "Implementing Single-Use Biomanufacturing Systems", Jeff Odum, CPIP, Pharmaceutical Technology, March 29, 2013
"Biomanufacturing, The 4th Decade: The Sky's the Limit", Jeff Odum, CPIP and Chuck Stock, CxA, Pharmaceutical Processing, Nov/Dec 2012, Vol. 27, No. 19
"SU Systems in Traditional Stainless-Steel Facilities", PharmTech.com Podcast:Jeff Odum, CPIP, March 29, 2013
“Facility of the Future: Next Generation Manufacturing Forum: Part 2: “Tools for Change-Enabling Technologies and Business and Regulatory Approaches” , Mark F. Witcher, PhD, Ruben Carbonell, PhD, Jeff Odum, CPIP, Peter Bigelow, Patricia Lewis and Michael Zivitz, Pharmaceutical Engineering, March/April 2013, Vol. 33 No. 2
“Facility of the Future: Next Generation Manufacturing Forum: Part I: “Why We Cannot Stay Here” – The Challenges, Risks, and Business Drivers for Changing the Paradigm,", Mark F. Witcher, PhD, Ruben Carbonell, PhD, Jeff Odum, CPIP, Peter Bigelow, Patricia Lewis and Michael Zivitz, Pharmaceutical Engineering, January/February 2013, Vol. 33 No. 1
November, 2012. Book of Downstream Industrial Biotechnology, Dr. Michael C. Flickinger (Ed.), Biopharmaceutical Facility Validation (part IV), Jeff Odum, CPIP, Hoboken, NJ: John Wiley & Sons, Inc.
"Single-Use in a Stainless Steel World". Jeff Odum, CPIP, Pharmaceutical Processing, October 2012, Vol. 27, No. 9
"Biopharmaceutical Manufacturing in the Twenty-First Century - the Next Generation Manufacturing Facility", Mark F. Witcher, PhD and Jeff Odum, CPIP, Pharmaceutical Engineering, March/April 2012, Vol. 32 No. 2
"NextGen Biomanufacturing: Developing the Manufacturing Facility of the Future", Jeff Odum, CPIP, Chuck Stock, MBA, Diana Karnas and Gene Martini, PE, Pharmaceutical Processing, March 2012
Dave Wareheim quoted, “Leveling Downstream Process Bottlenecks”; Genetic Engineering News, May 1 2010 (Vol. 30, No. 9)