Shadle Consulting Services
Good Science is Good Compliance
::  Publications  ::
Paula Shadle, Ph.D.
  • Shadle, P.J.  Managing the global supply chain.  Editorial in BioPharm Intl May 2008, 21:74.
  • Shadle, P.J.  Outsourcing GMP manufacturing of drugs and biologics.  Specialty Chemicals Magazine 28:14-16, 2008.
  • Shadle, P.J.  Writing effective development reports.  BioPharm International S1 (Sept 2006):  33-37.
  • Shadle, P.J.  Gearing up for pre-approval inspections.  BioPharm International (April 2006):
  • Shadle, P.J.  Current challenges for GMP raw materials.  (Sep/Oct 2005).  BioPharm International:  33-35.
  • Shadle, P.J.  Designing effective stability studies during biopharmaceutical product development.  American Pharmaceutical Review, Dec 2004: 1-6.
  • Shadle, P.J.  An introduction to cGMP.  BioPharm.  International, 2004
  • Shadle, P.J.  Navigating CAPA.  Bioprocessing Journal, October 2004, pp 2-8.
  • Shadle, P.J.  BSE offers lessons in risk assessment.  BioPharm International, July 2004, 17: 24-33.
  • Shadle, P.J.  Raw materials qualification:  How to assess and control quality.  In BioPharm International, Feb 2004, 17: 28-35.
  • Shadle, P.J.  The art of raw material and supplier qualification.  Bioprocessing Journal, Dec 2004 
  • Shadle, P.J.  Outsourcing and insourcing:  The transition from a virtual to a ‘real’ quality group.  Presented at:  PDA Annual Meeting, Atlanta, GA, Nov 2003.
  • Shadle, P.J.  Moving QA out onto the manufacturing floor.  BioPharm International, 2003.
  • Shadle, P.J., Smith T, McAllister P, Lubiniecki AS.  Evaluation of viral clearance: Use of statistics.  Invited presentation and panel member at the FDA/NAID Conference on HIV Vaccines, Bethesda, MD, February 1996.
  • Lubiniecki, A.S., Erickson, J.C., Nolan, C.L., Scott, R.G., Shadle, P.J., Smith, T.M., and D.W. Zabriskie.  Preparation of clinical trial supplies of biopharmaceuticals.  In Handbook of Pharmaceutical Technology, Oxender, Ed., 1999.
  • Shadle, P.J.  Development of recovery processes for recombinant proteins and peptides.  In:  Development of Biopharmaceutical Parenteral Dosage Forms, Bontempo, J.A., Ed., pp.31-90.  New York:  Marcel Dekker, 1997.  (Review article).
  • Lubiniecki, A.S., Shadle, P.J.  (1997).  Raw material considerations.  In Brown F., Fernandez J. (Eds.)  Development of Specifications for Biotechnology Pharmaceutical Products.  Dev. Biol. Stand. 91:65-72.
  • Del Tito, B.J., Tremblay, M.A., Shadle P.J.  (1996).  Qualification of raw materials for clinical biopharmaceutical manufacturing.  BioPharm 9:45-49.  Also published in Pharmaceutical Technology Europe, 9:44-48, 1997.
  • Lubiniecki A.S., McAllister P.R., Smith T.M., Shadle P.J.  (1996).  Process evaluation for biopharmaceuticals:  What is appropriate in process evaluation?  Dev. Biol. Standard. 88:309-315.
  • McAllister, P.R., Shadle P.J., Smith T.M., Scott R.G., Lubiniecki A.S.  (1996).  Use of a statistical strategy to evaluate sources of variability in viral safety experiments for a recombinant biopharmaceutical.  Dev. Biol. Standard.  88:111-121.
  • McAllister, P.R., Shadle, P.J., Smith, T.M., Scott, R.G. and Lubiniecki, A.S. (1996).  Determining a confidence interval for viral clearance evaluation studies using statistics. Dev. Biol. Stand. 88:100-110.
  • Shadle, P.J., McAllister, P.R., Smith, R.M., Lubiniecki, A.S.:  Viral validation strategy for recombinant products derived from established animal cell lines.  In Beuvery E.C., Griffiths, J.B., Zeijlemaker W.P. (Eds):  Animal Cell Technology.  Development towards the 21st century.  Dordrecht Kluwer, 1995, pp. 631-635.
  • Shadle, P.J., McAllister, P.R., Smith, T.M., Lubiniecki, A.S., (1995).  Viral validation strategy for recombinant products derived from established animal cell lines.  Cytotechnology 14:1-10, 1995. (Also in ESACT Proceedings).
  • Shadle, P.J., Aldwin, L., Nitecki, D., Koths, K. (1989).  Human macrophage colony-stimulating factor heterogeneity results from alternative mRNA splicing, differential glycosylation, and proteolytic processing.  J. Cellular Biochem 40:91-107.
  • Shadle, P.J. Allen, J.I., Geier, M.D., Koths, K. (1989).  Detection of endogenous macrophage colony stimulating factors in human blood.  Exp. Hematol. 17:154-159.
  • Halenbeck, R., Shadle, P.J., Lee, P-J. Lee, M., Koths, K. (1988).  Purification and characterization of recombinant human macrophage colony-stimulating factor and generation of a neutralizing antibody useful for Western analysis.  J. Biotechnol. 8:45-58.
  • Ralph, P., Ladner, M.B., Wang, A.S., Kawasaki E.S., McConlogue, L., Weaver, J.F., Weiss, S.A., Shadle, P.J., Koths, K., Warren, M.K. (1987).  The molecular and biological properties of the human and murine members of the CSF-1 family.  In Webb, D.R., Pierce C.W., Cohen, S., Eds. The Molecular  Basis of Lymphokine Actions, pp. 295-315.
  • Shadle, P.J., Gerke, V., Weber, K. (1985).  Three Ca2+ -binding proteins from porcine liver and intestine differ immunologically and physicochemically and are distinct in Ca 2+ affinities.  J. Biol. Chem. 260: 16354-1630.
  • Shadle, P.J. and Weber, K. (1986).  Calcium binding protein from porcine intestine binds to phosphatidylserine vesicles in the presence of calcium. Biochim. Biophys. Acta.
  • Shadle, P.J. and S.H. Barondes (1984).  Platelet-collagen adhesion: Evidence for participation of antigenically distinct entities.  J. Cell Biology 99:2048-2055.
  • Shadle, P.J., and S.H. Barondes (1982).  Adhesion of human platelets to immobilized trimeric collagen.  J. Cell Biology 95:361-365.
  • Roberson, M.M., Ceri, H., Shadle, P.J., Barondes, S.H. (1981).  Heparin-inhibitable lectins: marked similarities in chicken and rat.  J. Supramolecular Structure and Cellular Biochemistry 15:395-402.
  • Ceri, H., Shadle, P.J., Kobiler, D., Barondes, S.H. (1979). Extracellular lectin and its glycosaminoglycan inhibitor in chick muscle cultures.  Ibid. 11:61-67.
Doris Conrad