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about

Schauer Biologics Consulting provides strategic planning and tactical support for process development and manufacturing activities at both startups and established biologics companies. Dr. Schauer, the principal consultant, is a versatile and accomplished executive scientist with a successful record of innovative leadership in biologics technology, process development and manufacturing.

At Avaxia Biologics, Dr. Schauer, was Senior VP of Technical Operations; where he was responsible for Process Development, Manufacturing, Quality and Program Management. In previous positions (Inspiration Biopharmaceuticals, Hospira, Millipore, Biogen Idec,  and Genetics Institute\Wyeth), Dr. Schauer held positions of increasing responsibility associated with biologics: technology, manufacturing, process development, research, and project\program\portfolio management.


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SERVICES

  • Strategic planning and tactical support of Biologics process development and manufacturing activities at startup and established biologics companies

  • Oversight of internal process development, tech transfer, and manufacturing

  • Oversight of external process development, tech transfer, and manufacturing performed at Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs)

    • Authoring, issuing, and tracking of Request for Proposals (RFPs) to (CMOs) and (CROs).

    • Evaluation and selection of CMOs and CROs based on issued proposals

    • CMO\CRO site selection audits

    • Oversight and management of interactions with selected CMOs\CROs  

  • Successful at biologics: manufacturing, process development, research, project\ program\ portfolio Management and Team Leadership

  • Authoring of Chemistry Manufacturing and Control (CMC) reports, and CMC sections of regulatory filing


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experience

 


AVAXIA BIOLOGICS - SENIOR VICE PRESIDENT, TECHNICAL OPERATIONS

  • Reported directly to the CEO, and was a member of Avaxia’s senior management team, which was responsible for developing and implementing Avaxia’s overall strategic plan
  • Responsible for Technical Operations within the company, which included all aspects of Process Development, Manufacturing, Quality and Program Management

  • Responsible for developing and implementing the company’s proprietary antibody manufacturing technology platform for orally administered gut targeted therapies

    • Developed robust and cost effective Phase 2 ready manufacturing processes for a unique gut stable, orally delivered, polyclonal antibody product (AVX-470) used to treat Ulcerative Colitis and Crohn's disease

    •  Required the successful implementation of creative food-grade intermediary processing of a natural product raw material

    • Required the development of a creative, robust and cost effective affinity purification process

    • Required the successful development of a creative enterically coated microparticle Drug Product for oral drug delivery

    • Successfully identified, selected, and oversaw natural product raw material suppliers

    • Successfully identified and selected food grade intermediary processors, GMP Drug Substance and GMP Drug Product contract manufacturers  

  • Responsible for ensuring CMC regulatory compliance

    • Successfully obsoleted an internally focused quality system and implemented an externally focused quality system that was specifically designed to take advantage of and oversee vendor’s quality systems.

inspiration biopharmaceuticals - Vice President, Process Science

  • Reported to the CEO and was a member of Inspiration’s Executive Management Team, responsible and accountable for Inspiration’s technical challenges and accomplishments
    • Responsible for evaluation of process development, protein manufacturing, characterization, optimization, and manufacturing technologies
    • Responsible for the definition and implementation of process strategies in both clinical and commercial settings
  • Directly accountable for overall CMC leadership of the Phase III  recombinant porcine factor VIII product (OBI-1) for the treatment of serious bleeding episodes in patients with acquired hemophilia-A, including:
    • All aspects of Drug Substance and Drug Product development necessary for commercialization of the product
    • OBI-1 was successfully commercialized and is currently licensed to Baxalta under the brand name OBIZUR
  • Directly accountable for the overall CMC leadership of a Phase III recombinant human factor IX product (IXinity) for treatment of congenital hemophilia-B, including:
    • All aspects of Drug Substance and Drug Product development necessary for commercialization of the product
    • The Factor IX product was successfully commercialized and is currently licensed to Emergent BioSolutions under the brand name IXinity.


hospira - Senior Director: Process Development, Global Biologics R&D

  • Successfully managed Drug Substance and Drug Product process development activities associated with Hospira’s portfolio of biosimilar products
  • Successfully provided strategic leadership to improve Global Biologics Process Development capabilities including enhancing CMC planning and execution competence 
  • Successfully provided direct Global oversight of Drug Substance and Drug Product technical organizations located in Lake Forest IL, Chennai India, Adelaide Australia
  • Directly responsible for all biologics process development associated with Hospira’s “One-2-One” Global Biologics contract manufacturing

MILLIPORE - Director: DOWN-STREAM PROCESSING (DSP) Research and Development

  • Responsible for scientific and managerial leadership of a 120 person R&D organization with a $20M annual budget.   The DSP R&D Department was organized into four independent functional areas consisting of Purification Development, BioSafety Development, Mobius (disposables) Development, and DSP Research
  • Innovative products such as Viresolve® Pro and Pro+, ChromaSorb™, ProResS, and ProSep® Ultra Plus were released to Manufacturing (RTM) during my tenure  
  • New innovative\disruptive sterilizing filtration technologies based on “electrospin” nanofiber methodologies were initiated under my direction

MILLIPORE - Director: Technology and Pre-Development

  • Responsible for scientific and managerial leadership of the Technology and Pre-development department (T&PD) with a $10M annual budget.  This Creativity\Innovation based group consisted of approximately 50 free thinking A.S., B.S., M.S., and Ph.D. level Scientists and Engineers organized into three independent innovation groups:
    • Expression Technologies
    • Separation Technologies
    • and Process Analytical Technologies  
  • Responsible for identifying\developing innovative and creative new technologies and for providing the entry point of projects and products into the product development pipeline.  “Smart Polymer” development was initiated during my direction of the T&PD group
  • Actively involved in redefinition of the stage gate process used to monitor and regulate the progress of innovation projects in the pre-development pipeline
  • Successfully played an active role in defining the technology innovation strategy of the Bioprocess division

  

BIOGEN IDEC - Director: Cambridge Manufacturing Sciences

  • Responsible for scientific and managerial leadership of approximately 20 A.S., B.S., M.S., and Ph.D. level Scientists and Engineers organized into three independent groups:
    • Cell Culture and Cell Banking
    • Purification and AFO
    • Data Systems and Analysis  
  • This group oversaw the tech transfer of manufacturing processes into Biogen Idec’s Cambridge Manufacturing facility (Drug Substance) and AFO facility (Drug Product).  Tech Transfer is a matrix management oriented function that requires integration of numerous disciplines including: Process Development, QC, QA, Regulatory, Documentation, Facilities, Manufacturing, and many others  
  • Responsible for oversight of formal investigations associated with major deviations encountered during commercial and clinical manufacturing campaigns (both drug substance and drug product). Responsibilities include presentation of investigation results to global regulatory inspectors and auditors  
  • Responsible for data mining and analysis of manufacturing data for assessment of process conformity

 

BIOGEN IDEC -  Program Manager: Program and Alliance Management

  • Program Manager for four early Development Programs, including one alliance program  
  • Responsible for coordination of program related interdepartmental activities, development of integrated timelines and integrated development plans
  • Project Manager: Research Operations
    • Responsible for managing numerous early-stage Neurobiology and Immunology oriented early research projects, including small molecule projects.  Responsibilities included project, resource and financial planning
    • Helped to guide and advised individual project leaders.  In addition, worked closely with members of Biogen Idec’s Research Management, Legal, Contract Management, Budget, and Finance groups

Genetics Institute\ Wyeth - Principal Scientist\Lab Head, Microbial Fermentation and Recovery

  • Played a leadership role in strategic management of Product and Process Development at Genetics Institute (now Pfizer)
  •  Successfully established and validated numerous master and working cell banks
  • Successfully developed and optimized numerous fermentation processes resulting in high expression levels at high cell densities. Many of these processes were used to produce human pharmaceuticals under "cGMP" conditions for phase I, phase II and phase III clinical studies and for production of commercial drug substance (rhIL-11, Neumega)
  •  Successfully developed downstream processing steps including cell harvest, product release, clarification, and refolding
  • Responsible for scale‑up of fermentation and downstream processes, to the appropriate manufacturing scales
  • Responsible for transfer of fully developed processes to Clinical and Commercial Manufacturing
  • Successfully devised methods used to overcome the physiological restraints associated with over-expression of heterologous gene products in recombinant microorganisms
  • Invented generic procedures for the purification of inclusion bodies from recombinant microorganisms
  • Developed procedures for large scale protein refolding
  • Successfully established, qualified, and validated fermentation and recovery specific assays, including quantitative protein assays from complex mixtures such as whole cell lysates.
  • Successfully generated research quantities of recombinant proteins to internal and external groups.  These ranged from crude cell lysates to gram quantities of homogeneous refolded proteins.
  • Successfully managed a group of up to ten A.S., B.S., M.S., and Ph.D. level Development Scientists and Engineers, as well as Manufacturing Personnel

 

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PRESENTATIONS

Risk Based Development and Manufacturing of Biosimilars.  Schauer, N.  October 2018. Abstr. 13th International Conference on Biologics and Biosimilars, Boston, USA

Novel Stability and Concentration Enhancing Formulations for Improved Administration of Biotherapeutics. Schauer, N. August, 2016, Abstr. The Eight Annual BIOPROCESSING SUMMIT. Boston, MA.

 

AVX-470, an Orally-Delivered GI-Targeted anti-TNF Biobetter. Schauer, N. October, 2015. Abstr. OMICS International Annual Conference.  Baltimore MD.

 

Getting More Done with Less: Case Study of an Early Clinical Stage Company. Schauer, N. October, 2014. Abstr. BioProcess International Annual Conference.  Boston MA.

 

Thoughts on the Development and Manufacture of Biosimilars. Schauer, N. October, 2012. Abstr. AAPS Annual Meeting Symposium, Challenges and Strategies for Biosimilars Manufacturing, Chicago IL. 

Strategies for Development and Manufacturing of Biosimilars.  Schauer, N.  October, 2011. Abstr. BioProcess International Annual Conference, Pre-Conference Symposium on Global Strategies and Experience in the Development of Biosimilars, Real-World Solutions to Improve Speed, Cost and Predictability. Long Beach, CA.

 

Project Management: You Can Get What You Want ...And What You Need. Schauer, N.  2001. Abstr. IBC 2nd Annual Conference, Transitions from Bench to Clinic. Boston MA. IBC USA Conferences Inc.

 

Inclusion Body Protein Refolding. 1993. DeBernardez-Clark, E., and N.L. Schauer. Abstr. Engineering Foundation, Biochemical Engineering VIII, Princeton NJ, #32.

 

Refolding of Human Macrophage Colony Stimulating Factor. Tran-Moseman, A.T., E. DeBernardez-Clark, and N.L. Schauer.  1992.    Abstr. AICHE Annu. Fall Meet. Product Recovery and Purification-II, 32e.

 

Refolding of Escherichia coli derived Human Macrophage Colony Stimulating Factor. DeBernardez-Clark E., A.T. Tran-Moseman, and N.L. Schauer.  1992. Abstr. Engineering Foundation, Recovery of Biological Products VI, Interlaken Switzerland.

 

Parameters Affecting the Refolding of Human Macrophage Colony Stimulating Factor. DeBernardez-Clark E., A.T. Tran-Moseman, and N.L. Schauer.  1992.    Abstr. Ninth International Biotechnology Symposium, Washington D.C.

 

A Novel and efficient plasmid maintenance system for long term fermentation of Escherichia coli. McColgan, J.M., E.R. LaVallie, B.L. Murray, J.M. McCoy, P.F. Schendel and N.L. Schauer.  1990.    Abstr. AM. Chem. Soc., Annu. Fall Meet, BIOT 185. 

 

A Generic Procedure for the Purification of Inclusion Bodies. McColgan, J.M., J. Seehra, and N.L. Schauer.  1990.  Abstr. AM. Chem. Soc. Annu. Fall Meet, BIOT 201.

 

A Novel Two-Stage Semi-Continuous Culture System for Production of Recombinant Proteins in Escherichia coliK-12.McColgan, J.M., S.L. Young, and N.L. Schauer.  1989.    Abstr. AM. Soc. Microbiol. Annu. Meet, O 74.

 

Cyanide Inhibition of Formate Dehydrogenase from Methanobacterium formicicum. Ferry, J.G., N.L. Schauer, and & M.J Barber. (1985), Abstr. Fed. Proc. 44, 1425.

 

Effect of molybdenum starvation and tungsten on the synthesis of formate dehydrogenase and coenzyme F 420 in Methanobacterium formicicum. May, H. D., N. L. Schauer, and J. G. Ferry. 1983. Abstr; Fourth Intentional Symposium: Microbial Growth on C-l Compounds.

 

FAD requirement for reduction of Coenzyme F 20 by formate and hydrogenase from Methanobacterium formicicum. Schauer, N. L., D. P. Brown, and J. G. Ferry. 1983. Abstr. Annu. Meet. , Am Soc. Microbiol. K58, p. 186.

 

Methanogenesis: a novel molybdenum center in Methanobacterium formicicum. Barber, M. J., L. M. Siegel, N. L. Schauer, H. D. May, and J. G. Ferry. 1982. Abstr. Fed. Prod. 41:891.

 

Isolation and characterization of formate dehydrogenase from Methanobacterium formicicum. Schauer, N. L., and J. G. Ferry. 1981. Abstr. Fed. Proc. 40:1666.

 

Characterization of formate dehydrogenase in Methanobacterium formicicum strain JF-1. Schauer, N. L., and J. G. Ferry. 1980. Abstr. Annu. Meet, Am. Soc. Microbiol. K 85, p. 140.

 

Lead concentrations in feathers of woodcocks collected from the United States.  O'Brien, T. G., P. F. Scanlon, N. L. Schauer, and R.. G. Oderwald. 1978. Abstr. Virginia Academy of Science.

 

Heavy metal levels in feathers of wild turkeys from Virginia.  O'Brien, T. G., P. F. Scanlon, N. L. Schauer, D. E. Steffen, and J. L. Coggin. 1978. Abstr. Virginia Academy of Science.


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publications

Challenges and Strategies for Biosimilars Manufacturing: Session Review Article. A Jayatilaka, R Waghmare, C Kirchhoff, N Schauer, M Siwak, G Jones. April 2013.  AAPS MSE News Letter.

 

Renaturation of Escherichia coli-Derived Recombinant Human Macrophage Colony-Stimulating Factor. A. Tran-Moseman, N. Schauer, E. De Bernardez Clark. 1999. Protein Expression and Purification, Vol. 16, 181-189

 

Archaea: a laboratory manual. Frank T. Robb – 1995. PROTOCOL 18: Purification of Formate Dehydrogenase from Methanobacterium formidcum. NL Schauer and JG Ferry.

 

Identification of molybdopterin guanine dinucleotide in formate dehydrogenase from Methanobacterium formicicum. JL Johnson, NR Bastian, NL Schauer, JG Ferry.  1991.  FEMS Microbiology Letters. Volume 77, Issues 2-3, 15 January, Pages 213-216

 

Formate growth and pH control by volatile formic and acetic acids in batch cultures of methanococci NL Schauer, WB Whitman. July 1989. Journal of Microbiological Methods. Volume 10, Issue 1, Pages 1-7.

 

Composition of the coenzyme F420-dependent formate dehydrogenase from Methanobacterium formicicum.  NL Schauer, JG Ferry.  1986. Journal of bacteriology, - Am Soc Microbiol.  Vol. 165, No. 2

 

Mechanistic studies of the coenzyme F420-reducing formate dehydrogenase from Methanobacterium formicicum. NL Schauer, JG Ferry, J F Honek, WH Orme-Johnson, C Walsh. 1986. Biochemistry - ACS Publications, Vol. 25, 7163-7168 7163

 

Cloning, expression, and nucleotide sequence of the formate dehydrogenase genes from Methanobacterium formicicum.  AP Shuber, EC Orr, MA Recny, PF Schendel, HD May, NL Schauer and JG Ferry. 1986. THE JOURNAL OF BIOLOGICAL CHEMISTRY by the American Society of Biological Chemists, Inc. Vol. 261, No. Issue of October 5, pp. 12942-12947.

Molybdopterin cofactor from Methanobacterium formicicum formate dehydrogenase. HD May, NL Schauer, JG Ferry. 1986. Journal of Bacteriology, - Am Soc Microbiol. Vol. 166, No. 2

 

FAD requirement for the reduction of coenzyme F420 by formate dehydrogenase from Methanobacterium formicicum.  NL Schauer, JG Ferry.  Aug 1983. Journal of bacteriology, - Am Soc Microbiol, p. 467-472 Vol. 155, No. 2 0021-9193/83/080467-06

 

Formate dehydrogenase from Methanobacterium formicicum. Electron paramagnetic resonance spectroscopy of the molybdenum and iron-sulfur centers.  MJ Barber, LM Siegel, NL Schauer, HD May and JG Ferry. 1983. THE JOURNAL OF BIOLOGICAL CHEMISTRY Vol. 258, No. 18, Issue of September 25, pp. 10839-10845.

 

EPR and Potentiometric Studies of Formate Dehydrogenase (FDH) from Methanobacterium formicicum. MJ Barber, LM Siegel, NL Schauer, HD May, JG Ferry. (l983). "Some Recent Developments in the Chemistry of Chromium, Molybdenum and Tungsten" (J.R. Dilworth & M.F. Lappert, Eds.), Royal Society of Chemistry, Dalton Division, 3-4.

 

Properties of formate dehydrogenase in Methanobacterium formicicum.  NL Schauer, JG Ferry. Apr. 1982.  Journal of bacteriology, p. 1-7 Vol. 150, No. 1 0021-9193/82/040001- 07

 

Kinetics of formate metabolism in Methanobacterium formicicum and Methanospirillum hungatei.  NL Schauer, DP Brown, JG Ferry. Sept. 1982. APPLIED AND ENVIRONMENTAL MICROBIOLOGY, Vol. 44, No. 3 p. 549-554 0099-2240/82/090549-06

 

Metabolism of formate in Methanobacterium formicicum. NL Schauer, JG Ferry. 1980. Journal of Bacteriology, - Am Soc Microbiol. Vol. 142, No. 3 p. 800-807 0021-9193/80/06-0800/08.

 

Heavy metal levels in feathers of wild turkeys from Virginia. PF Scanlon, TG O'Brien, NL Schauer, RG Oderwald, JL Coggin. 1979. Bull. Environm. Contam. Toxicol. 21,591-595.

 

A modified blow-gun syringe for remote injection of captive wildlife. RJ Warren, NL Schauer, JT Jones, PF Scanlon. October, 1979. Journal of Wildlife Diseases - Wildlife Dis Assoc Vol. 15, No. 4, 537

 

Lead levels in primary feathers of American woodcocks harvested by hunters throughout the United States range. PF Scanlon, TG O'Brien, NL Schauer, RG Oderwald. 1979. Bull. Environm. Contam. Toxicol. 21, 683-688.

Field Techniques for Detection and Evaluation of Crop Gland Activity in Mourning Doves. RE Mirarchi, PF Scanlon, NL Schauer. 1978. Proc. Ann. Conf S.E. Assoc. Fish & Wildl. Agencies. 32, 75-81.

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Patents

Excipient compounds for protein processing. David S. Soane, Philip Wuthrich, Robert P Mahoney, Mark Moody, Daniel G. Greene, Neil L. Schauer, Patent numbers: US 2019 / 0054175 A1. WO2018152165. Aug 08, 2018. Reform Biologics, LLC

Rigid disposable flow Path. Martin Morrissey, Neil Schauer. Patent number: US 009494259B2.  Nov 15, 2016. EMD Millipore Corporation

 

Rigid disposable flow path. Martin Morrissey, Neil Schauer. Application: US 20140090738 A1. April 3, 2014. EMD Millipore Corporation

 

Rigid disposable flow path. Martin Morrissey, Neil Schauer. Application: US 20120000566 A1. January 5, 2012. Millipore Corporation

 

Rigid disposable flow path. Martin Morrissey, Neil Schauer. Application: WO 2012003185 A1. January 5, 2012. Millipore Corporation

 

Small scale cell culture container. Brett Belongia, Neil Schauer. Application: US 20080138891 A1. June 12, 2008. Millipore Corporation

 

Self-standing bioreactor construction. Brett Belongia, Neil Schauer, Stephen Proulx. Application: US 20080131960 A1. June 5, 2008. Millipore Corporation

Bioreactor construction. Brett Belongia, Neil Schauer. Application: US 20080131959 A1. June 5, 2008. Millipore Corporation

 

 A Bioreactor. ‎Brett Belongia, Neil Schauer. Application: EP 1923461 A1. May 21, 2008. ‎Millipore Corporation

 

Protein recovery & purification methods. Steven M. Vicik, Neil L. Schauer, James R. Mercer, Edward R. LaVallie, Catherine A. Briasco, Jeffrey S. Deetz, Dwight Winters, Jenifer L. Thomas. Patent number: 5760189. June 2, 1998. Genetics Institute, Inc.


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EDUCATION

University of Georgia, Athens GA

Department of Microbiology,

Postdoctoral Research Associate

 

Virginia Polytechnic Institute, Blacksburg VA

Ph.D., Anaerobic Microbiology

(Cunningham Research Fellow)

 

Virginia Polytechnic Institute, Blacksburg VA

B.S., Biochemistry and Biology

 


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Contact

Name *
Name

Neil Schauer, Ph.D. 
Principal Consultant
Schauer Biologics Consulting
Milford MA
Neil@SchauerBiologics.com