Share this page: More
 

Mark A. Schenerman

Mark A Schenerman
Department Affiliation: Primary: Pharmacology and Molecular Sciences
CMC Biotech-MAS Consulting
Degree: Ph.D., University of Florida
Rank: Adjunct Professor
Telephone Number : 443-289-1200
E-mail address: mark@cmcbiotech-mas.com
Address: 1 Cornfield Court, Reisterstown, MD  21136

Development of biopharmaceuticals to address infectious disease and cancer.

My research interests have focused on finding ways to design, develop, and implement novel therapeutic proteins into clinical trials.  The department that I led at MedImmune (over 200 scientists) was responsible for developing analytical methods that defined the quality, potency, safety and stability of these proteins.  Our work was collaborative with Discovery Research groups that were engineering the proteins, pre-clinical safety groups (Toxicology), Process Development, Formulation, Device Development, Regulatory Affairs, and Quality Assurance.  We also had external collaborations with academic institutions such as Johns Hopkins University (e.g., Raman spectroscopy for identity testing) and government institutions such as NIST (e.g., NMR of complex proteins).  Our group’s strength has been characterization of proteins to answer questions about how post-translational modifications and changes in higher order structure can impact bioactivity, pharmacokinetics, and stability.  Our group also answered questions about impurities at the ng-pg/mL levels such as: 1) what is the nature of the impurity?  2) how did it form? and 3) how can it be removed?

 

Representative Publications:  

  • Barton, C., Spencer, D., Levitskaya, S., Feng, J., Harris, R., and Schenerman, M.A.  Heterogeneity of IgGs: Role of Production, Processing, and Storage on Structure and Function. In:Technologies for Therapeutic Monoclonal Antibody Characterization Volume 1. Monoclonal Antibody Therapeutics: Structure and Function, ACS Symposium Series; American Chemical Society: Washington, DC, 2014. pp. 69-92. 
     
  • Jiang, X-R, Song, A., Bergelson, S., Arroll, T., Parekh, B., May, K., Chung, S., Strouse, R., Mire-Sluis, A., and Schenerman, M.  Advances in the Assessment and Control of the Effector Functions of Therapeutic Antibodies. Nature Reviews in Drug Discovery, 10: 101-110, 2011.  Pub Med Reference
     
  • Schenerman, M.A., Axley, M.J., Oliver, C.N., Ram, K., and Wasserman, G.F.  Using a Risk Assessment Process to Determine Criticality of Product Quality Attributes.  In: Rathore, AS, Mhatre, R, editors.  Quality by Design for Biopharmaceuticals: Perspectives and Case Studies.  Wiley Interscience.  pp. 53-84, 2009.
     
  • Wei, Z., McEvoy, M., Razinkov, V., Polozova, A., Li, E., Casas-Finet, J., Tous, G., Balu, P., Pan, A., Mehta, H., and Schenerman, M.A.  Biophysical Characterization of Influenza Virus Subpopulations Using Field Flow Fractionation and Multiangle Light Scattering: Correlation of Particle Counts, Size Distribution, and Infectivity.  J. Virol. Meth. 144:122-132, 2007. Pub Med Reference
     
  • Wei, Z., Feng, J., Lin, H.-Y., Mullapudi, S., Bishop, E., Tous, G.I., Casas-Finet, J., Hakki, F., Strouse, R. and Schenerman, M.A.  Identification of a Single Tryptophan Residue as Critical for Binding Activity in a Humanized Monoclonal Antibody against Respiratory Syncytial Virus.  Anal. Chem. 79: 2797–2805, 2007.  Pub Med Reference
     
  • Tous, G.I., Wei, Z., Feng, J., Bilbulian, S., Bowen, S., Smith, J., Strouse, R., McGeehan, P., Casas-Finet, J., and Schenerman, M.A.  Characterization of a Novel Modification to Monoclonal Antibodies: Thioether Cross-link of Heavy and Light Chains. Anal. Chem., 77: 2675-2682, 2005.  Pub Med Reference 
     
  • Leister, K.J., Schenerman, M.A. and Racker, E. Altered Sensitivity of System A Amino Acid Transport to Ouabain in Normal and Transformed C3H-10T1/2 Cells During the Cell Cycle.  Proc. Natl. Acad. Sci. 86: 783-786, 1989. Pub Med Reference 


 



Other graduate programs in which Dr. Schenerman participates:  None