Publications and Expert Insight
Knowledge, Skill and Passion is at the core of our business. At IPS, our Subject Matter Experts (SMEs) are recognized worldwide for their ideas, insights and leadership within pharmaceuticals, biotechnology and life sciences.
Our SME's provide global training to professionals, corporations and regulators. They have shared their insight and operational expertise with organizations such as the FDA, Health Canada and Chinese SFDA, as well as their cutting-edge technical knowledge and substantial achievements with students at recognized universities and community colleges.
Our publications include contributions to a number of recognized reference books, industry standards, journals and publications. our most recent through leadership pieces include:
- "Aseptic Equipment Trends", Jason Collins, RA, NCARB, PHARMAevolution, May 7, 2013
- "Tableting and Encapsulation Equipment Trends", Russ Somma, PhD, PHARMAevolution, May 6, 2013
- "Why Face Time with Regulators is Critical to PAT/QbD Success", Russ Somma, PhD, PHARMAevolution, May 2, 2013
- Podcast: "Optimizing Execution with Modular Construction", John Gilroy, PE, April 2013
- Optimizing Execution with Modular Construction", John Gilroy, PE and Gene Martini, PE, Pharmaceutical Processing, IPS Technologies Tours Supplement, April 2013
- Podcast: "Multiproduct Facilities", Russ Somma, PhD, Sam Halaby, Mike Vileikis, April 2013
- "Multiproduct Facilities: Considerations Beyond Cleaning", Russ Somma, PhD, Sam Halaby, Mike Vileikis, Pharmaceutical Processing, IPS Technologies Tours Supplement, April 2013
- Podcast: "Biomanufacturing in the 4th Decade", Jeff Odum, CPIP, April 2013
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Podcast: "On the Floor with Chuck Stock at INTERPHEX 2013: The IPS Biomanufacturing Tour", Chuck Stock, CxA, PHARMAevolution, April 2013
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Podcast: "Implementing Single-Use Biomanufacturing Systems", Jeff Odum, CPIP, Pharmaceutical Technology, March 29, 2013
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"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
- “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
- "Emerging Fourth Generation Barrier Technologies", Sterling Kline, RA, Pharmaceutical Processing, March 2013
- “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
- "Modular Construction Considerations", John Gilroy, PE and Gene Martini, PE, Pharmaceutical Processing, Nov/Dec 2012, Vol. 27, No. 19
- “Breaking Steel’s Grip”, Jeff Odum, CPIP, San Fernando Valley Business Journal, October 29, 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., November 2012
- "Single-Use in a Stainless Steel World". Jeff Odum, CPIP, Pharmaceutical Processing, October 2012, Vol. 27, No. 9
- "Resource Scheduling in QC Laboratories", Rafi Maslaton, Pharmaceutical Engineering, September/October 2012, Vol. 32 No. 5
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"The Containment Expert", Sterling Kline, RA,, Pharmaceutical Processing, August 2012, Vol. 27 No. 7
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"Lean Manufacturing: Which Lean approaches and tools are best suited for the Pharmaceutical Industry", Rafi Maslaton, Pharmaceutical Processing, July 2012, Volume 27 Number 6
- "NextGen Biomanufacturing: Developing the Manufacturing Facility of the Future", Jeff Odum, CPIP,. Chuck Stock, CxA, Diana Karnas, Gene Martini, PE, Pharmaceutical Processing, March 2012, INTERPHEX 2012 Supplement
- "Should it be Scale-up or Scale Out...Bigger is Not Always Better or Faster", Russ Somma, PhD, Mike Vileikis, Felix Diaz, RA, Sam Halaby, Pharmaceutical Processing, March 2012, INTERPHEX 2012 Supplement
- "Case Study: Brazil Fill/Finish: The Role of CMOs in supporting Global Vaccine Production Needs", Sterling Kline, RA, Rob Roy, PE, Jason Collins, RA, NCARB, Pharmaceutical Processing, March 2012, INTERPHEX 2012 Supplement
- "Resource Planning in QC Laboratories", Rafi Maslaton, Pharmaceutical Engineering, March/April 2012, Volk. 32 No. 2
- "Biopharmaceutical Manufacturing in the Twenty-First Century - the Next Generation Manufacturing Facility", Mark F. Witcher PhD and Jeff Odium, CPIP, Pharmaceutical Engineering, March/April 2012, Volk. 32 No. 2
- "Single-use Disposable Systems for Aseptic Fill/Finish", Jason Collins, RA, NCARB and Rob Roy, PE, Contract Pharma, June 2011
- Dave Wareheim quoted, “Leveling Downstream Process Bottlenecks”; Genetic Engineering News, May 1 2010 (Volk. 30, No. 9)
- "Enhancing Delivery of Complex Facilities with Building Information Modeling (BIN) Technology", Andrew A. Signore, PE, PNP-DBIA, CPI and Steve Franey, RA; Pharmaceutical Engineering, September/October 2009, Volume 29, Number 5
- "Building Better Partnerships by Leveraging BD", Russ Soma, PhD, PharmaManufacturing,com, July 22, 2009
- "Green for Green’s Sake: Energy-efficient Design can Help Reduce Laboratory Operating Costs", Patrick Boccio, PE, ISP DC Newsletter, Summer 2009
- "Up in the Air", Russ Soma, PhD, Pharmaceutical Executive, January 1, 2009
- “Embracing Quality by Design: Applying BD concepts can help CMS create value”, Russ Somma, PhD and Andrew A. Signore, PE, PMP-DBIA, CPIP; Contract Pharma, October 2008
- “Steam Humidification in Pharmaceutical Facilities”, Mark Butler, Engineering Systems, September 2008
- "How Quality by Design is Changing Drug Development", Russ Somma, PhD, Pharma QbD.com, August 2008
- “No More Approvable Letters: An Expert’s Take”, Russ Somma, PhD; PharmExecBlog, July 16, 2008
- "A Healthy Step: Applying GMPs to Dietary Supplements”, Ed Tannebaum, AIA and Chuck Stock, CxA; Nutritional Outlook, Vol. 22, Issue 1, January/February 2008
- "Development Knowledge Can Increase Manufacturing Capability and Facilitate Quality by Design", Russ Somma, PhD; Journal of Pharmaceutical Innovation, December 2007
- "FDA's "Approvable" Problem", Russ Somma, PhD, Pharmaceutical Executive, November 2007
- “Energy Savings in Pharmaceutical Facilities: A Risk-Based Approach”, Dave Goswami, PE and Mark Butler; Pharmaceutical Engineering, November/December 2007
- “Implementing the ASTM standard for verification: Standard’s key objective is to give industry-wide flexibility regarding implementation”, Chuck Stock, CxA; CleanRooms, October 2007
- "Using Technology Transfer to Maximize Business Efficiency”, Russ Somma, PhD; Pharmaceutical Engineering, September/October 2007
- A Technology Viewpoint: “Aspects of Non-Invasive Drug Therapy”, Russ Somma, PhD; LifeSciTech, Q3 2007
- “Operation Excellence: Leveraging Lean Techniques”, by Mike Gadway and Rafi Maslaton; LifeSciTech, Q4 2007
- Sterling Kline, RA quoted in "Barrier and Isolation Systems: Technology in Transition"; CleanRooms, Volume 21, No. 4, April 2007
- Sterling Kline, RA quoted in "Isolator Technologies Slowly Catching On"; Genetic Engineering News, Dec 1 2006 (Vol. 26, No. 21)