Herbert Lutz

I enjoy science- learning & discovering and I enjoy engineering - applying science and logical reasoning to solve technical and managerial challenges.


Perspective

I enjoy science- learning & discovering and I enjoy engineering - applying science and logical reasoning to solve technical and managerial challenges.   I found out I am good at this so it is very satisfying to see results working out and getting good feedback from customers, academics and colleagues.
Biotech is still fairly new but remains a quickly moving field with never ending opportunities to learn and contribute.  Our company provides critical technologies for the industry and I see myself as playing a part in defining, developing, and implementing these.  New ideas come from the focused study of industry challenges to create what Pasteur described as "the prepared mind".  Then one needs to reflect, apply fundamental principles, and read/listen about new developments for inspiration or borrowing similar methods, test ideas and learn from failure. 

I enjoy science- learning & discovering and I enjoy engineering - applying science and logical reasoning to solve technical and managerial challenges.

Herbert Lutz

Global Principal Consultant

Profile

Joined Merck KGaA, Darmstadt, Germany: 1993

Key research fields and topics:

  • Sterile, virus, and depth filtration
  • TFF and ultrafiltration/ diafiltration
  • Adsorbers
  • Virus inactivation
  • Continuous/ intensified processes
  • Regulatory/validation

Prizes and awards:

  • Who's who; best presentations at ACS and AIChE mtgs
  • Stauffer scholarship

CV & Scientific activities

References

Publications/Conference Presentations/Patents:

  • “The Efficacy of a Simple Static Cleaning Procedure for single Pass Tangential Flow Filtration (SPTFF)”, Torsten Bisschop, Karen Chan, Herb Lutz, submitted to Biopharm Int., July 2018
  • “Investigating the combination of single-pass tangential flow filtration and anion exchange chromatography for intensified mAb polishing”, Thomas Elich, Elizabeth Goodrich, Herb Lutz, Usma Mehta, submitted to Biot. Prog., 2018
  • “Next Generation mAb Processing: Technical and Regulatory Considerations”, Herb Lutz & Brian Hubbard, Millipore Webinar, July 2018
  • “Bioprocess Intensification using SPTFF”, Herb Lutz, Oxford Continuous Biomanufacturing conference, June 2018 
  • “Characterizing and Enhancing Virus Removal by Protein A Chromatography”, Min Zhang, Alejandro Becerra-Arteaga, Herb Lutz, Qi Chen “submitted to J. Chrom A, 2018
  • “Continuous In-line viral Inactivation”, Herb Lutz, Bioforum Japan, Bioforum Shanghai, Bioforum Seoul, May 2018
  • “What’s Next: Making Next Generation Manufacturing Work”, Herb Lutz, Supplement to The Medicine Maker, Nov. 2017
  • “Application of single pass TFF to enable intensified and continuous biological manufacturing”, Herb Lutz, poster, Integrated Continuous Biomanufacturing III, Sept. 2017
  • “Intensified chromatography”, Mathilde Bourgignat, Herb Lutz, Nicholas LaRoudie, Continuous Oxford Conference, June 2017
  • “Continuous Virus Inactivation”, Herb Lutz, presentation to FDA CBER OBP, May 2017
  • “High Concentration Biotherapeutic Formulation and Ultrafiltration: Part 1 pressure limits”, Herb Lutz, Joshua Arias, Yu Zou, Biotechnol. Prog., 33 (2017)113-124
  • “Effect of Product Concentration on Continuous Parvovirus- Retentive Filtration”, David Bohonak, Herb Lutz, ACS BIOT, San Francisco, CA, Apr 2017
  • “Linking single pass tangential flow filtration with anion exchange chromatography for intensified mAb processing”, Thomas Elich, Elizabeth Goodrich, Herb Lutz, Ushma Mehta, ACS BIOT, San Francisco, CA, Apr 2017
  • “Filters in Biotech”, Herb Lutz, AIChE Ann. Mtg., San Francisco, CA, Nov 2016
  • “Aggregates in Bioprocessing Overview”, Herb Lutz, Millipore webinar, Sept 2016
  • “Next Generation Biomanufacturing”, Herb Lutz, Millipore Japan Bioforum, May 2016
  • “Virus Filtration QbD”, Herb Lutz, invited lecture to FDA CBER OBP, Feb 2016
  • “High Viscosity Ultrafiltration Formulation for mAbs and Plasma IgG”, Herb Lutz, Millipore webinar, Feb 2016
  • “Quality by Design (QbD) Viresolve Pro Support Document”, Herb Lutz, ACS Annual Mtg., Denver CO, Mar 2015• “An effective strategy for a comprehensive QbD characterization of Viresolve filter: a collaboration between Medimmune and EMD Millipore, Gisele Ferreira, David Roberts, Herb Lutz, ACS Annual mtg., Denver, CO, Mar 2015
  • “Novel System Design and Cleaning Strategies for Single-Pass Tangential Flow Filtration Systems”, Herbert Lutz, Karen Chan, Jonathan Steen, Joseph Parella, Seat Yee Lau, ACS Annual mtg., Denver, CO, Mar. 2015
  • “Inline Spiking Method for Validating Continuous Virus Filtration“, Herb Lutz, poster at Continuous Processing Conference, Berkeley, CA, Nov. 2015
  • “Robust Depth Filter Sizing for Centrate Clarification”, Herb Lutz, Kate Chefer, Michael Felo, Benjamin Cacace, Sarah Hove, Bin Wang, Mark Blanchard, George Oulundsen, Rob Piper, Xiaoyang Zhao, Biotechnol. Prog., 31(2015)1542-1550
  • Ultrafiltration for Bioprocessing, Herb Lutz, Elsevier, Cambridge, UK, 2015
  • “Inline Spiking Method for Linked Virus Filter Validation”, Herb Lutz, Continuous Bioprocess Symposium, NC Biot Center, Oct 2014
  •  “The Impact of Process Interruptions on Parvovirus Filter LRV”, Herb Lutz, India Virus Forum, Apr. 2014
  • “Quality by Design (QbD) Viresolve Pro Support Document”, Herb Lutz, India Virus Forum, Apr. 2014• “Best Practices for High Concentration Ultrafiltration”, Herb Lutz, Shanghai Technical Seminar, Apr. 2014
  • “Single Pass Tangential Flow Filtration (SPTFF)”, Herb Lutz, Shanghai Technical Seminar, Apr. 2014
  • “Sizing of Robust and Cost Effective Filtration Processes Using Safety Factors”, Herb Lutz, Shanghai Technical Seminar, Apr. 2014
  • “An Alternate Diafiltration Strategy to Mitigate Protein Precipitation for Low Solubility Proteins”, Eva Gefroh, Herbert Lutz, Biotechnol. Prog., online Feb 2014
  • BPP 2013 Session Chair, Newport, RI• “Sterile Filtration Principles: Best Practices and New Developments”, Ch. 16, Herbert Lutz, Randy Wilkins, Christine Carbrello, in Sterile Product Development, P. Kolhe, N. Rathore eds., Springer, 2013
  • “Performance of a Salt-Tolerant Membrane Adsorber in Flow-Through Mode”, XueJun Han, Herb Lutz, Kate Chefer, Alejandro Becerra-Arteaga, Mark Blanchard, Tony Hong, Xiaoyang Zhao, Art Hewig, Venkatesh Natarajan”, Bioprocess Int., 11(2), Feb 2013, 28-39
  • “ISPE Guide: Biopharmaceutical Process Development and Manufacturing “, 2013
  • “Inline Spiking Method for Linked Virus Filter Validation”, Herbert Lutz, Eva Gefroh, Wayne Chang, Tamas Blandl, Gisela Ramsey, Joe Parrella, John Fisher, Invited lecture to FDA CDER/CBER 2012
  • “Ultrafiltration of High Concentration Proteins”, Recovery of Biologicals XV”, Herb Lutz, , 2012
  • “Evaluation of an Alternate Diafiltration Strategy to Mitigate Protein Precipitation for Low Solubility Proteins”, Eva Gefroh, Herbert Lutz, Biotechnol. Prog., ACS Mar 2012
  • “Performance of a Salt-Tolerant Membrane Adsorber in Flow-Through Mode”, XueJun Han, Herb Lutz, Kate Chefer, Alejandro Becerra-Arteaga, Mark Blanchard, Tony Hong, Xiaoyang Zhao, Art Hewig, Venkatesh Natarajan”, ACS mtg, Apr. 2011
  • “Qualification of a novel inline spiking method for virus filter validation”, Herbert lutz, Wayne Chang, Tamas Blandl, Gisela Ramsey, Joe Parrella, John Fisher, Eva Gefroh, ACS mtg., 2011
  • “Qualification of a novel inline spiking method for virus filter validation”, Herbert lutz, Wayne Chang, Tamas Blandl, Gisela Ramsey, Joe Parrella, John Fisher, Eva Gefroh, Biotechnol. Prog., Vol. 27, No. 1, 2011, pp121-128
  • “Ultrafiltration: Fundamentals and Engineering”, Ch. 2.06, Herbert Lutz in Comprehensive Membrane Science and Engineering, E. Dricoli ed., Elsevier, 2010
  • “Rationally defined safety factors for filter sizing”, Herbert Lutz, J. of Membr. Sci., 341(2009)268-278
  • “Considerations for Scaling-up Depth Filtration of Harvested Cell Culture Fluid”, Herb Lutz, Ian Abbott, Mark Blanchard, Ananth Parampalli, George Setiabuti, Vijay Chiruvolu, Megumi Noguchi, Biopharm. Int., Mar 2009, 58-66
  • “Membrane Separation Processes” Ch.20 in “Perry’s Chemical Engineers’ Handbook, D.W. Green and R.H. Perry eds., McGraw-Hill, 2008
  • “Ultrafiltration Process Design and Implementation” Ch. 10, Herbert Lutz, Bala Raghunath, in “Process Scale Bioseparations for the Pharmaceutical Industry”, A.A. Shukla, M. R. Etzel, S. Gadam eds., CRC Taylor & Francis, 2007
  • “Filtration Best Practices and New Developments”, AIChE, San Francisco, Nov. 2006
  • “Ultrafiltration Process Design and Implementation”, H. Lutz, B. Raghunath, Ch. 10 in Process Scale Bioseparations for the Biopharmaceutical Industry, Shukla et. al. eds., CRC Taylor & Francis, Boca Raton, FL, 2007
  • “Designing Robust Filtration Processes for Fill-Finish Operations”, ACS Prospectives, San Diego, July 2006
  • “Integrity Testing of Normal Flow Parvovirus Filters using Air-Liquid based Tests”, G. Bolton, J. Cormier, M. Krishnan, J. Lewnard, H. Lutz, Bioprocessing Journal, Nov/Dec 2005.
  • “Performance of a membrane adsorber for trace impurity removal in biotechnology manufacturing”, M. Phillips, J. Cormier, J. Ferrence, C. Dowd, R. Kiss, H. Lutz, and J. Carter, J. Chromatogr. A, 1078 (2005) 74-82
  • “Downstream Purification…Technology & Productivity Trends”, ISPE Conference, Arlington, VA, June 2004
  • “Virus Filtration”, FDA invited lecture, Jan 2004
  • “Viral filtration of plasma-derived human IgG”, H Lutz, M Siwak, G Bolton, T Ireland, Downstream, PPB ’03 abstracts, Amersham Biosciences, Jan 2004
  • “Technologies for Ensuring the Safety of Biopharmaceuticals”, Massachusetts Biotech Council Forum, Dec 2003
  • “Viral Clearance Technologies: Process development and validation”, IBC Validation for the Production of Biologicals, Munich, Dec 2003
  • “Membrane Adsorber Technology for Trace Contaminant Removal Applications”, H. Lutz, M. Phillips, FDA invited lecture, Nov 2003
  • “Improving throughput and viral clearance of a monoclonal antibody production process”, H Lutz, G Kemp, D Low, J McCue, M Phillips, I Quiñones-Garcia, BioLOGIC Asia, Singapore, Nov 2003
  • “Biotechnology…  Trends and New Directions”, AIChE Boston Section, Oct 2003
  • “Rapid development, robust manufacturing.  Millipore’s expertise and enabling technology for producing MAbs”, UBS East Coast Biotechnology Bus Tour, Aug. 2003
  • “Viral Filtration of Plasma Derived Human IgG”, H Lutz, M Siwak, G Bolton, Plasma Product Biotectechnology Meeting, Curacao, April 2003, published in Downstream, PPB Meeting 2003, Amersham Biosciences, 2004, pp 21-22
  • “Membrane Adsorber Technology for Trace Contaminant Removal Applications”, H. Lutz, M. Phillips, IBC Process Validation, Mar 2003
  • “Review of novel technologies for use as a virus barrier to eliminate adventitious contamination of viral drug products”, H Lutz, R Pearce, ACS Annual Mtg New Orleans, Mar 2003
  • “Validation of Virus Filtration: Ensuring Regulatory Compliance”, BioProcess International, Vol.1, No. 1, Jan 2003, 52-62
  • “Membrane Adsorber Technology for Trace Contaminant Removal Applications”, H. Lutz, M. Phillips, PDA Annual Mtg, New Orleans, Dec. 2002
  • “Performance of a Novel Viresolve NFR Virus Filter”, H. Brough, C. Antoniou, J. Carter, J. Jakubik, Y. Xu, and H. Lutz, Biologicals, 2002
  • “Proven Strategies for Obtaining Optimal & Scalable Process Development Data”, H. Lutz, R. Shaw, IBC Scaling-Up, San Diego, August 2002
  • “An overview of viral filtration in biopharmaceutical manufacturing”, J Carter, H Lutz, European J. of Parent. Sci., 7 (2002) 72-78
  • “TSE Clearance by  Viresolve”, EMEA Workshop, London, UK, June 2002
  • “Monoclonal Purification:  Innovative Bioseparation Technology from Millipore”, Millipore Seminar, Seoul, Korea and Beijing, China, May 2002
  • “Technologies for Ensuring the Safety of Biopharmaceuticals”, H. Lutz, J. Carter, Millipore Bioforum, Tokyo, May, 2002
  • “Viral Clearance Performance and Regulatory Requirements”,  H. Lutz, M. Siwak, J. Carter, Biological Safety and Production 2002, Washington DC, April 2002
  • “Membrane Adsorber Technology for Trace Impurity Removal Applications”, H. Lutz, M. Phillips, J. Ferrence, C. Dowd, IBC Production Week, San Diego, Nov. 2001
  • “Virus Removal from Pharmaceuticals by Filtration”, PDA Japan, Tokyo, November 2000
  • “Non-enveloped Viral Retention by Membranes”, European Medicines and Evaluation Agency Workshop, London, UK, September 2000
  • “Optimizing Viral Filtration”, Presentation and Panel discussion with regulators and vendors, Biological Safety and Production 2000, Washington DC, June 2000
  • “Viresolve NFR Filters”, Poster presentation, Biological Safety of Pharmaceuticals 2000, Washington DC, June 2000
  • “ Development and Qualification of a Novel Virus Removal Filter for Cell Culture Applications”, S. Liu, M. Carroll, R. Iverson, C. Valera, J. Vennari, K. Turco, R. Piper, R. Kiss, and H. Lutz, Biotechnology Progress, ACS/AIChE, May/June 2000
  • “A Novel Virus Barrier for Serum Free Media”, S. Liu, M. Carroll, R. Iverson, R. Kiss, R. Piper, and H. Lutz, Biological Safety & Production 99, Boston, April 1999
  • “Filtration and the Removal of Viruses from Biopharmaceuticals”, R. Levy, M. Phillips, and H. Lutz, Ch 20 in Filtration in the Biopharmaceutical Industry, T. H. Meltzer and M. W. Jornitz eds., Marcel Dekker, 1998, pp. 619- 646
  • “Virus Filtration in Biotechnology Applications”, H. Lutz, 2nd IBC Symposium, Philadelphia, PA, June 1998
  • “Optimized Diafiltration Strategies”, H. Lutz, North America Membrane Society Annual Mtg., Cleveland, OH, May 1998
  • “Viral Clearance: Regulations and Methods”, R. Levy, V. Pizzi, and H. Lutz, PDA Annual Mtg., November 1997
  • US Pat# 5,597,486, Membrane Filtration with Optimized Addition of Second Liquid to Maximize Flux, Herb Lutz, January 1997

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