Brian Hubbard, Ph.D.

Professional experience

CMC Bioprocess Consulting, LLC

10/14- present Chief Executive Officer

Providing consulting services to the Biopharma industry drawing from nearly 25 years of process development experience within three major Biopharma Organizations. Experience includes process development and regulatory filings supporting greater than 100 clinical stage and 8 commercial products. A demonstrated leader in technology development and innovation in the industry for next generation bimanufacturing technologies.

Amgen Corporation

Process and Product Development

2006- 2014 Scientific Executive Director

Head of Technology Development and Innovation for Amgen in Purification Process Development and Pilot Plant Operations (8 years)

-Process Equipment Technology Forum Leader

-Downstream Technology Forum Leader

Technology development in the areas of Manufacturing of the Future, Flexible Manufacturing, Continuous processing, Upstream, Harvest and Downstream Technologies including Single Use Systems, Purification Process Technologies including Resins, Filters, etc.

Responsible for R&D Technical Collaborations between Amgen and Key Vendors (16 years).

Portfolio of collaboration programs resulted in the development of numerous vendor products that have addressed both Amgen and the biotech industries process development and manufacturing needs.

2004- 2006 Director, Purification Process Development

2002- 2004 Associate Director, Purification Process Development

Director of the Purification Process Development Department at Amgen and Immunex (8 years). Leader of department of ~40-50 scientists and engineers responsible for development of the harvest and downstream processes for Amgen’s portfolio of clinical and commercial candidates.

Immunex Corporation

Process Sciences

1998- 2002 Director, Product Recovery / Purification Process Development

Genetics Institute (Wyeth Biopharma / Pfizer)

Process and Product Development

1998- 1998 Senior Scientist

1994- 1998 Principal Scientist

1992-1994 Staff Scientist II

1991- 1992 Staff Scientist I

Group Leader in Purification Process Development. Responsible for the development of purification processes for clinical and commercial biotherapeutic candidates.

Education

1988 - 1991

HARVARD MEDICAL SCHOOL

Dept. of Biological Chemistry and Molecular Pharmacology

Advisor: Dr. Christopher T. Walsh

TUFTS UNIVERSITY

School of Medicine

Dept. of Medicine and Biochemistry.

New England Medical Center

Center for Hemostasis and Thrombosis Research

Advisor: Drs. Bruce and Barbara C. Furie

Postdoctoral Research Fellowship (Joint Appointment Harvard Medical School and Tufts School of Medicine)

1982 - 1988

BROWN UNIVERSITY

Department of Chemistry

Advisor: Dr. David E. Cane, Chairman

Doctor of Philosophy in Chemistry

1978 - 1982

SYRACUSE UNIVERSITY

School of Arts and Sciences

Bachelors of Science in Chemistry/Biology, cum laude

Additional professional activities

Scientific Advisory Committee - BioProcess International Conference and Exhibition, September 4-7, 2018 Boston, MA.

Session Chair: Bioprocess International Conference, Pre-Conference Symposium: Viral Safety, September 4-7, 2018 Boston, MA

Session Chair: Bioprocess International Conference, Recovery and Purification Track, September 4-7, 2018 Boston, MA

Organizer: 2013 Viral Clearance Symposium, October 16-18, 2013 Princeton, NJ

Session Chair: Integrated Continuous Biomanufacturing, Session 3: Downstream Processing: Alois Jungbauer and Brian Hubbard, October 20-24, 2013 Castelldelfels, Spain

Organizer: 2013 PDA Europe Virus & TSE Safety Forum, June 4-6, 2013 Berlin, Germany

Award Recipient: 2013 Amgen P&PD Cross Functional Collaboration Award: Connected Process Implementation / Technology Team

Organizer: 2012 PDA / FDA Virus and TSE Safety Conference, May 15-17, 2012 Bethesda, MD

Award Recipient: 2012 Amgen P&PD Cross Functional Collaboration Award: Flocculation Harvest Task Force

Organizer: 2011 Viral Clearance Symposium, November 1-2, 2011 San Francisco, CA

Steering Committee: Symposium on Amgen’s Experience of the Large Molecule. March 16, 2011 Thousand Oaks, CA.

Scientific Advisory Board: IBC’s 26^th International Antibody Development and Production Conference. March 16-18, 2011 Bellevue, WA

Scientific Advisory Committee - Recovery and Purification Track, BioProcess International Conference and Exhibition, October 12-16, 2009 Raleigh, NC.

Scientific Advisory Committee - Recovery and Purification Track, BioProcess International Conference and Exhibition, 2008, Anaheim, CA.

Scientific Advisory Committee- Recovery and Purification Track, BioProcess International Conference and Exhibition, October 1-4, 2007 Boston, MA.

Session Chairperson for sessions: “Overcoming the Challenges of the Ton Scale Process”, Regulatory Guidance, Validation, and Viral Clearance” BioProcess International Conference and Exhibition, October 1-4, 2007 Boston, MA.

Chairperson, for sessions: “Antibody Clinical Experience and Relation to Product Quality”, Managing Manufacturing at Multiple Sites and Post Approval Changes”, “Strategies for Intellectual Property” and “Advances in Downstream Processing”. IBC Antibody Production and Downstream Processing Conference, March 8-11, 2005 San Diego, CA.

Conference Chair, Chromatography Session. Recovery of Biological Products Conference, Banff, Canada, 2003.

Program Co-Chairman, 26 Sessions, Division of Biochemical Technology, 216^th National Meeting of the American Chemical Society, Boston, MA. August 23-27, 1998.

Executive Committee Member, American Chemical Society Division of Biochemical Technology, Long Range Programming. 1997-1998

25 Year Member, American Chemical Society. Divisional memberships in Biochemical Technology, Biological Chemistry, Analytical Chemistry, Medicinal Chemistry, and Chromatography.

Member, American Association for the Advancement of Science.

Member, Parenteral Drug Association (PDA).

Selected publications, Presentations, and Patents

Webinar: Herb Lutz, Brian Hubbard “Next Generation MAb Processing: Technical and Regulatory Considerations” July 12, 2018 (available on demand at www.emdmillipore.com)

Getting to Grips with the New Generation: How will Biopharmaceutical Process Development be Affected by Next Generation Technologies, Lutz, H., Hubbard, B., The Medicine Maker, (2018) submitted.

Plenary Lecture: Hubbard, B., “Downstream Process Development: Past, Present and Future”, 2016 Osong BioExcellence Conference, Daejeon, South Korea. October 6, 2016.

Invited Keynote Address: Hubbard, B., “Downstream Process Development: Past, Present and Future”, BioForum Japan. Tokyo, Japan. May 26, 2016.

Whitepaper: Proceedings of the 2013 Viral Clearance Symposium. Johannes Blümel, Kurt Brorson, Dayue Chen, Brian Hubbard, George Miesegaes, David Roush, Hannelore Willkommen. PDA Journal of Pharmaceutical Science and Technology (2015) 69 (1) 140 -212.

Meeting Report: 2013 PDA Virus and TSE Safety Forum. Willkommen, H., Blumel, J., Brorson, K., Chen, D., Chen, Q., Groner, A., Hubbard, B.R., Kreil, T.R., Ruffing, M., Ruiz, S. Scott, D., Silvester, G. PDA Journal of Pharmaceutical Science and Technology (2014) 68 (3) 193-214.

Whitepaper: Proceedings of the 2011 Viral Clearance Symposium (South San Francisco), Johannes Blümel, Kurt Brorson, Dayue Chen, Brian Hubbard, George Miesegaes, David Roush, Hannelore Willkommen. PDA Journal of Pharmaceutical Science and Technology (2014) 68 (1) 1-101.

Invited Visit/ Presentation: In-Line Spike Methodology for Viral Clearance Studies. FDA, White Oaks Laboratories and FDA NIH Campus, Sept 10-11, 2012.

Viral Clearance by Protein A Chromatography. Brian Hubbard and Lisa Connell Crowley. Proceedings of the 2009 Viral Clearance Symposium, (2010) Developments in Biologicals 133 17-20.

Low pH Viral Inactivation. Brian Hubbard and Lisa Connell Crowley. Proceedings of the 2009 Viral Clearance Symposium, (2010) Developments in Biologicals 133 28-32.

Invited Oral Presentation: Hubbard, B. “Future Directions in Purification Technologies”. Leaders in Bioprocessing Lecture Series, Keck Graduate Institute, Claremont, CA, April 30, 2009.

Invited Oral Presentation: Hubbard, B. “Future Directions in Purification Technologies”. SBE’s 2nd annual Conference on Accelerating Biopharmaceutical Development. San Diego, CA. March 9-12, 2009.

Invited Oral Presentation: Hubbard, B. “Viral Clearance by Protein A chromatography“. Hosted by Eli Lilly & FDA. Indianapolis, IN. March 16-17, 2009.

Invited Oral Presentation: Hubbard, B. “Low pH Viral Inactivation”. Hosted by Eli Lilly & FDA. Indianapolis, IN. March 16-17, 2009.

Process Scale Purification of Antibodies. Chapter 4: Protein A Based Affinity Chromatography. Vunnum, S., Vedantham, G., Hubbard, B. (2009) U. Gottschalk (ed.) J. Wiley and Sons. Hoboken, NJ.

Invited Panelist: Hubbard, B, in “Emerging, Disruptive Technologies: Disruptive Science and Technology”. SBE’s 2nd annual Conference on Accelerating Biopharmaceutical Development. March 9-12, 2009. San Diego, CA.

Invited Panelist: Hubbard, B in “Protein A Capture - Perception and Reality” session at IBC's 22nd Antibody Development & Production Conference, March 4-6, 2009, Carlsbad, CA.

Invited Panelist: Hubbard, B in “Using Simulating Moving Bed or Other Multi Column Approaches to Increase Downstream Processing Efficiencies, Especially in New High Titer Processes” session at IBC's 22nd Antibody Development & Production Conference, March 4-6, 2009, Carlsbad, CA.

Invited Panelist: “Industry – Supplier Forum on Needs for New Technology Development for Downstream Processing”. Bioprocess International Conference and Exhibition, 2008, Anaheim, CA.

Downstream Processing of Monoclonal Antibodies – Application of Platform Approaches. Abhinav A. Shukla, Brian Hubbard, Tim Tressel, Sam Guhan and Duncan Low. (2007) J Chromatogr B. Special Thematic Issue: Antibodies (848) 28–39

Binding capacity differences for antibodies and Fc-fusion proteins on protein A chromatographic materials. Ghose S, Hubbard B, and Cramer SM. (2006) Biotechnology and Bioengineering 96 (4), 768-779.

“Platform Approaches to Monoclonal Antibody Purification”

Keynote Presentation. Hubbard B. Bioprocess International 2006 Conference, Prague, Czech Republic, February 20-23, 2006.

Evaluation and comparison of alternatives to Protein A chromatography Mimetic and hydrophobic charge induction chromatographic stationary phases. Ghose S, Hubbard B, and Cramer SM. (2006) J Chromatogr A. 1122 (1-2), 144-152.

Process Purification of Antibodies and Fc-fusion Proteins: Protein A and Beyond. Sanchayita Ghose, Brian Hubbard, and Steven M. Cramer. PREP-2006: 19th International Symposium, Exhibit & Workshops on Preparative /Process Chromatography, Ion Exchange, Adsorbtion/ Desorption Processes & Related Separation Techniques (2006).

“Platform Approaches to Monoclonal Antibody Purification”

Oral Presentation. Hubbard B. VisionGain. 2nd Annual Monoclonal Antibodies Conference. London. June 29, 2005

“Platform Approaches to Monoclonal Antibody Purification”

Oral Presentation. Hubbard B. IBC’s 14^th International Conference on Antibody Production & Downstream Processing. San Diego. March 8-11, 2005.

“Process Scale Purification of Monoclonal Antibodies: of Platforms, Pitfalls and Possibilities” Shukla, A. and Hubbard, B. 229th ACS National Meeting, San Diego, CA, March 13-17, 2005

“Use and Optimization of a Dual-Flowrate Loading Strategy to Maximize Throughput in Protein A Affinity Chromatography” Ghose S., Nagrath D., Hubbard B., Brooks C., and Cramer S.M. 229th ACS National Meeting, San Diego, CA, March 13-17, 2005

“Strategies To Address Aggregation During Protein A Chromatography”

Abhinav A. Shukla, Priyanka Gupta, Peter J. Hinckley, Yinges Yigzaw and Brian Hubbard. 229th ACS National Meeting, San Diego, CA, March 13-17, 2005.

“Strategies To Address Aggregation During Protein A Chromatography”

Abhinav A. Shukla, Priyanka Gupta, Peter J. Hinckley, and Brian Hubbard Recovery of Biological Products Conference. Banff (2005)

Strategies To Address Aggregation During Protein A Chromatography

Abhinav A. Shukla, Peter J. Hinckley, Priyanka Gupta, Yinges Yigzaw, and Brian Hubbard (2005) BioProcess International 3 (5) 36-44.

Protein Interactions in Hydrophobic Charge Induction Chromatography (HCIC).

Sanchayita Ghose , Brian Hubbard , and Steven M Cramer. (2005) Biotechnol. Prog., 21 (2), 498 -508.

Antibody variable region interactions with Protein A: Implications for the development of generic purification processes.

Sanchayita Ghose , Martin Allen , Brian Hubbard , Clayton Brooks , and Steven M Cramer. (2005) Biotechnology and Bioengineering 92 (6), 665-673.

Preparative protein purification on underivatized silica.

Sanchayita Ghose, Thomas M. McNerney, and Brian Hubbard, (2004) Biotechnology and Bioengineering 87 (3), 413-423.

“Protein Interactions in Hydrophobic Charge Induction Chromatography” Ghose, S., Hubbard, B. , and Cramer, S.M. 227th ACS National Meeting, Anaheim, CA, March 28-April 1, 2004.

“Evaluation of Viral Filters for Parvovirus Removal in MAb Process Development” XueJun Han, Abhinav A. Shukla, Brian Hubbard, Philip Clark, and Houman Dehghani^. 227th ACS National Meeting, Anaheim, CA, March 28-April 1, 2004.

Use and optimization of a dual-flowrate loading strategy to maximize throughput in protein-A affinity chromatography. Ghose S., Nagrath D., Hubbard B., Brooks C., and Cramer S.M. (2004) Biotechnol Prog. 20 (3) 830-40. Erratum in: (2004) Biotechnol Prog. 20 (5) 1614.

“Post-Approval Changes to the Downstream Enbrel®(etanercept) Commercial Process” Hubbard, B. Oral Presentation. IBC Life Sciences 10^th Antibody Production and Downstream Processing Conference. La Jolla, CA. March 5-7, 2003.

“Post-Approval Changes to the Enbrel® Commercial Process”

Hubbard, B. Oral Presentation. Amgen Process Development Symposium. San Diego, CA 2003.

“Scale-up and productivity optimization for Protein A chromatography” A. A. Shukla , P. Hinckley , B. Hubbard. 227^th ACS National Meeting, Boston, MA. August 18-22, 2002.

“Silica and it's application in downstream processing: A blast from the past” S. Ghose , T. M. McNerney , B. Hubbard. 227^th ACS National Meeting, Boston, MA. August 18-22, 2002.

pH Transitions in ion-exchange systems: role in the development of a cation-exchange process for a recombinant protein.

Sanchayita Ghose, Thomas M. McNerney, and Brian Hubbard. (2002)

Biotechnol Prog. 18 (3), 530-537.

Handbook of Bioseparations, Steve Cramer, William Hancock, Milton Hearn, and Brian Hubbard, Ed., Academic Press, ISBN 0120455404, 722pp (2000).

B.D. Kelley, L. Shi, D. Bonam, and B. Hubbard, "Robustness testing of a chromatographic purification step used in recombinant Factor IX manufacture", in Validation of Biopharmaceutical Manufacturing Processes, B.D. Kelley and R.A. Ramelmeier, ed., ACS Symposium Series (1998).

M.W. Leonard, L. Sefton, R. Costigan, L. Shi, B. Hubbard, D. Bonam, B.D. Kelley, B. Foster and T. Charlebois, "Validation of the recombinant coagulation Factor IX purification process for the removal of host cell DNA", in Validation of Biopharmaceutical Manufacturing Processes, B.D. Kelley and R.A. Ramelmeier, ed., ACS Symposium Series (1998).

L. Shi, B.D. Kelley, D. Bonam, and B. Hubbard. "Experimental design for validation of chromatographic process limits", BioPharm Meeting, San Francisco, May 1997.

B.D. Kelley, B. Hubbard, D. Bonam, C. Briasco, R. Costigan, B. Germain, P. Jennings, M. Leonard, J. Robinson, L. Shi, J. Thomas, R. Wright, “Experimental design for validation of chromatographic process limits for biopharmaceutical manufacturing”, Recovery of Biological Products VIII, Engineering Foundation, Tucson, October 1996.

Pentalenene synthase. Purification, molecular cloning, sequencing, and high level expression in Escherichia coli of a terpenoid cyclase from Streptomyces UC5319.

Cane, D.E., Sohng, J.K., Lamberson, C.R., Rudnicki, S.M., Wu, Z., Lloyd, M.D., Oliver, J.S., Hubbard, B.R. (1994) Biochemistry 33 (19), 5846-5857.

Effects of Interleukin-12 on Immune Responses and Host Protection in Mice Infected with Intestinal Nematode Parasites.

Finkelman, F.D., Madden, K.B., Cheever, A.W., Katona, I.M., Morris, S.C., Gately, M.K., Hubbard, B.R., Gause, W.C., Urban, J.F. Jr. (1994) J. Exp. Med. 179 (5), 1563-1572.

Administration of Recombinant IL-12 to Normal Mice Enhances Cytolytic Lymphocyte Activity and Induces Production of IFN- Gamma In Vivo.

Gately, M.K., Warrier, R.R., Honasoge, S., Carvajal, D.M., Faherty, D.A., Connaughton, S.E., Anderson, T.D., Sarmiento, U., Hubbard, B.R., Murphy, M. (1994) Int. Immunol. 6, (1) 157-167.

IL-12 Influences Intrathymic T Cell Development.

Godfrey, D.I., Kennedy, J., Gately, M.K., Hakimi, J., Hubbard, B.R., Zlotnik, A. (1994) J. Immunol. 152 (6) 2729-2735.

Effects of IL-12 on in vivo Cytokine Gene Expression and Ig Isotype Selection.

Morris, S.C., Madden, K.B., Adamovicz, J.J., Gause, ­W.C., Hubbard, B.R., Gately, M.K., Finkelman, F.D. (1994) J. Immunology 152 (3) 1047-1056.

Antitumor and Antimetastatic Activity of Interleukin 12 Against Murine Tumors.

Brunda, M.J., Luistro, L., Warrier, R.R., Wright, R.B., Hubbard, B.R., Murphy, M., Wolf, S.F., Gately, M.K. (1993) J. Exp. Med. 178 (4), 1223-1230.

Effect of In Vivo IL-12 Administration on Murine Tumor-Cell Growth.

OToole, M., Wolf, S.F., OBrien, C., Hubbard, B., Herrmann, S. (1993) J. Immunology 150 (8) 294.

Antitumor Activity of Interleukin-12 (IL-12) in Murine Tumor Models.

Brunda, M.J., Luistro, L., Warrier, R., Hubbard, B., Wolfe, S.F., Gately, M.K. 84th Annual Meeting of the American Association for Cancer Research, Orlando, Fl, USA May 19-22 1993. Proc. Am. Assoc. Cancer Res. Annu. Meet 34 (0) 464, 1993.

Effects of IL-12 In Vivo in Normal and Tumor-Bearing Mice.

Gately, M., Warrier, R., Honasoge, S., Luistro, L., Connaughton, S., Faherty, D., Murphy, M., Hubbard, B., Wolf, S., Brunda, M. Joint Meeting of the American Association of Immunologists and the Clinical Immunology Society, Denver, Co., USA. May 21-25, 1993. J. Immunol. 150 (8 part 2) 90A, 1993.

Effects of Interleukin-12 (IL-12) on an In Vivo T-Cell Dependent Humoral Immune Response.

Morris, S.C., Hubbard, B., Gately, M., Gause, W.C., Finkelman F.D. Joint Meeting of the American Association of Immunologists and the Clinical Immunology Society, Denver, Co., USA. May 21-25, 1993.J. Immunol. 150 (8 part 2) 45A, 1993.

Initial Characterization of the IL-12 Receptor IL-12R on Concanavalin-A Activated Mouse Splenocytes.

Chizzonite, R., Truitt R., Griffin M., Nickbarg E., Hubbard, B., Desai B., Stern A., Gubler U., Gately M. Keystone Symposium on Cytokines and Cytokine Receptors: From Cloning to the Clinic. Keystone, Co., USA, Jan. 31-Feb. 7, 1993. J. Cell. Biochem. Suppl. 0 (17 part B), 73, 1993.

Dioxygen Transfer During Vitamin K Dependent Carboxylase Catalysis.

Kuliopulos, A., Hubbard, B.R., Lam, Z., Koski, I.J., Furie, B., Furie, B.C., Walsh, C.T. (1992) Biochemistry 31 (33) 7722-7728.

Terpenoid Biosynthesis and the Stereochemistry of Enzyme-Catalysed Allylic Addition-Elimination Reactions.

Cane, D.E., Abell, C., Harrison, P.H., Hubbard, B.R., Kane, C.T., Lattman, R., Oliver, J.S., Weiner, S.W. Philos. Trans. R. Soc. Lond. [Biol] (ENGLAND) (1991) 332 (1263) 123-129.

Biosynthesis of Pentalenene and Pentalenolactone.

Cane, D.E., Oliver, J.S., Harrison, P.H., Abell, C., Hubbard, B.R., Kane, C.T., Lattman, R. J. Am. Chem. Soc. (1990) 112 (11) 4513-4524.

Biosynthesis of Lenoremycin and Pentalenolactone.

Hubbard, B.R. (1989) Diss. Abstr. Int. B. 1990, 50 (8), 3451.

Vitamin K-Dependent Carboxylase: Affinity Purification from Bovine Liver by using a Synthetic Propetide Containing the Gamma-Carboxylation Recognition Site.

Hubbard, B.R., Ulrich, M.M.W., Jacobs, M., Vermeer, C., Walsh, C., Furie, B., Furie, B.C. (1989) Proc. Natl. Acad. Sci. USA, 86 (18) 6893-6897.

Vitamin K-Dependent Carboxylation. In Vitro Modification of Synthetic Peptides Containing the Gamma-Carboxylation Recognition Site.

Hubbard, B.R., Jacobs, M., Ulrich, M.M., Walsh, C., Furie, B., Furie, B.C. (1989) J. Biol. Chem. 264 (24) 14145-14150.

The Role of the Propeptide in Synthesis of the Vitamin K-Dependent Proteins.

Furie, B.C., Hubbard, B.R., Ulrich, M.M.W., Jacobs, M., Furie, B., Walsh, C.T. (1989) Thrombosis and Haemostasis, 62 (1) 457.

Pentalenene Biosynthesis and the Enzymatic Cyclization of Farnesyl Pyrophosphate - Anti Stereochemistry in a Biological SE’ Reaction.

Cane, D.E., Abell, C., Lattman, R., Kane, C.T., Hubbard, B.R., Harrison, P.H. (1988) J. Amer. Chem. Soc. 110 (12) 4081-4082.

Polyether Biosynthesis 3. Origin of the Carbon Skeleton and Oxygen Atoms of Lenoremycin.

Cane, D.E., Hubbard, B.R. (1987) J. Am. Chem. Soc. 109 (21) 6533-6535.