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Monoclonal Antibody Therapies: Streamlining Development, Production, Costs

Monoclonal Antibody Therapies
Reported by
Marilynn Larkin

Posted August 31, 2007

Presented By

Biochemical Pharmacology Discussion Group and the Biochemical Group of the American Chemical Society (New York Section)


A monoclonal antibody (Mab) is a protein produced in the laboratory or in animals that, when injected into a patient, locates and binds to a specific antigen. There are many kinds of Mabs, each one made to find a different substance. Hailed more than three decades ago as "magic bullets" because of their specificity, Mabs are only now coming into their own as treatments for some types of cancer, and other diseases such as rheumatoid arthritis.

On May 22, 2007, monoclonal antibodies were the subject of a meeting of the Academy's Biochemical Pharmacology Discussion Group. Topics discussed included production of Mabs, pharmacokinetics, boosting efficacy, streamlining production, and moving them to the market.

Use the tabs above to view the meeting report and multimedia presentations.

Web Sites

Regeneron Pharmaceuticals
Read more about Regneron's VelocImmune and FASTR technologies here.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
This organization brings together regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry to set common technical guidelines and requirements for product registration. Documents relevant to monoclonal antibodies include ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (PDF, 152 KB) and a ICH M3: Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (PDF, 143 KB).

U.S. Food and Drug Administration
The FDA's guidelines for Mab development: Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (PDF, 140 KB).

European Agency for the Evaluation of Medicinal Products (EMEA)
Mab guidelines are available here: Production and Quality Control of Monoclonal Antibodies (Guideline 3AB4a) (PDF, 112 KB).

Journal Articles

Louis Weiner

Adams GP, Schier R, McCall AM, et al. 2001. High affinity restricts the localization and tumor penetration of single-chain fv antibody molecules. Cancer Res. 61: 4750-4755. FULL TEXT

Adams GP, Weiner LM. 2005. Monoclonal antibody therapy of cancer. Nat. Biotechnol. 23: 1147-1157.

Beckman RA, Weiner LM, Davis HM. 2007. Antibody constructs in cancer therapy: protein engineering strategies to improve exposure in solid tumors. Cancer 109: 170-179.

McCall AM, Shahied L, Amoroso AR, et al. 2001. Increasing the affinity for tumor antigen enhances bispecific antibody cytotoxicity. J. Immunol. 166: 6112-6117. FULL TEXT

Shahied LS, Tang Y, Alpaugh RK, et al. 2004. Bispecific minibodies targeting HER2/neu and CD16 exhibit improved tumor lysis when placed in a divalent tumor antigen binding format. J. Bio. Chem. 279: 53907-53914. FULL TEXT

Weiner KM, Adams GP. 2000. New approaches to antibody therapy. Oncogene 19: 6144-6151. FULL TEXT

Weiner LM, Borghaei H. 2006. Targeted therapies in solid tumors: monoclonal antibodies and small molecules. Hum. Antibodies 15: 103-111.

Joseph Balthasar

Deng R, Balthasar JP. 2007. Pharmacokinetic/pharmacodynamic modeling of IVIG effects in a murine model of immune thrombocytopenia. J. Pharm. Sci. 96: 1625-1637.

Hansen RJ, Balthasar JP. 2003. Pharmacokinetic/pharmacodynamic modeling of the effects of intravenous immunoglobulin on the disposition of antiplatelet antibodies in a rat model of immune thrombocytopenia. J. Pharm. Sci. 92: 1206-1215.

Hansen RJ, Balthasar JP. 2002. Effects of intravenous immunoglobulin on platelet count and antiplatelet antibody disposition in a rat model of immune thrombocytopenia. Blood 100: 2087-2093. FULL TEXT

Hansen RJ, Balthasar JP. 2002. Intravenous immunoglobulin mediates an increase in anti-platelet antibody clearance via the FcRn receptor. Thromb Haemost. 88: 898-899.

Lobo ED, Hansen RJ, Balthasar JP. 2004. Antibody pharmacokinetics and pharmacodynamics. J. Pharm. Sci. 93: 2645-2668.

Sally Ward

Ober RJ, Radu CG, Ghetie V, Ward ES. 2001. Differences in promiscuity for antibody–FcRn interactions across species: implications for therapeutic antibodies. Int. Immunol. 13: 1551-1559. FULL TEXT

Prabhat P, Gan Z, Chao J, et al. 2007. Elucidation of intracellular recycling pathways leading to exocytosis of the Fc receptor, FcRn, by using multifocal plane microscopy. Proc. Natl. Acad. Sci. USA 104: 5889-5894.

Vaccaro C, Bawdon R, Wanjie S, et al. 2006. Divergent activities of an engineered antibody in murine and human systems have implications for therapeutic antibodies. Proc. Natl. Acad. Sci. USA 103: 18709-18714. FULL TEXT

Vaccaro C, Zhou J, Ober RJ, Ward ES. 2005. Engineering the Fc region of immunoglobulin G to modulate in vivo antibody levels. Nat. Biotechnol. 23: 1283-1288.

T. Shantha Raju

Raju TS, Scallon B. 2007. Fc glycans terminated with N-acetylglucosamine residues increase antibody resistance to papain. Biotechnol. Prog. [in press].

Raju TS, Scallon B. 2006. Glycosylation in the Fc domain of IgG increases resistance to proteolytic cleavage by papain. Biochem. Biophys. Res. Commun. 341: 797-803.

Scallon BJ, Tam SH, McCarthy SG, et al. 2007. Higher levels of sialylated Fc glycans in immunoglobulin G molecules can adversely impact functionality. Mol. Immunol. 44: 1524-1534.


Keith Canada, PhD

Boehringer Ingelheim

Keith Canada is a senior scientist in the Biologics and Biomolecular Sciences division of Boehringer Ingelheim Pharmaceuticals.

Louis M. Weiner, MD

Fox Chase Cancer Center
e-mail | web site | publications

Louis Weiner is chairman of the Department of Medical Oncology and vice president of translational research at the Fox Chase Cancer Center. His work focuses on conducting translational research employing targeted therapy of cancer by antibody-based proteins. He serves on numerous National Cancer Institute review panels, including the Translational Research Working Group (TRWG), the Cancer Immunopathology and Immunotherapy (CII) study section, and the Rapid Access to Intervention Development (RAID) program oversight committee. Weiner completed his medical education at the Mount Sinai School of Medicine and has held fellowships at the New England Medical Center Hospital at Tufts University School of Medicine.

Joseph P. Balthasar, PhD

University of Buffalo
e-mail | web site | publications

Joseph Balthasar is an associate professor of pharmaceutical sciences at the University of Buffalo. He completed his PhD in pharmaceutics at the State University of New York at Buffalo. His research focuses on the application of pharmacokinetic and pharmacodynamic analyses to design new treatments for ovarian cancer and for autoimmune diseases.

E. Sally Ward, PhD

University of Texas Southwestern Medical Center
e-mail | web site | publications

Sally Ward is the Paul and Betty Meek–FINA Professor in Molecular Immunology at the University of Texas Southwestern Medical Center. Her laboratory's primary interest is in investigating how FcRn functions as an IgG transporter to regulate IgG levels throughout the body. She is also working to develop engineered antibodies that are altered in their binding properties for FcRn and, as such, can modulate FcRn function. Ward completed her undergraduate and doctoral degrees at the University of Cambridge and held two fellowships there before migrating to the United States.

T. Shantha Raju, PhD

e-mail | publications

Shantha Raju is a research fellow at Centocor R&D, a biotechnology company owned by Johnson & Johnson.

Kevin Bailey, PhD

Regeneron Pharmaceuticals
e-mail | publications

Kevin Bailey is vice president of preclinical manufacturing and process development at Regeneron Pharmaceuticals.

Gordon Moore, PhD


Gordon Moore is senior director of cell biology at Centocor Pharmaceutical Development.

Patrick Garidel, PhD

Boehringer Ingelheim
e-mail | publications

Patrical Garidel is head of pharmaceutical basic development at Boehringer Ingelheim Pharma GmbH & Co. KG, based in Biberach an der Riss, Germany.

Paul Andrews, PhD

Patrys Limited
e-mail | publications

Paul Andrews is vice president of research and development at Patrys, Ltd. His duties include designing, implementing, and managing nonclinical safety assessment programs to support clinical development of Patrys' IgM monoclonal antibodies; preparing regulatory submissions; participating in IND-candidate selection; formulating early clinical development plans; and participating in partnering efforts. Prior to joining Patrys, he was assistant vice president of toxicology at ImClone Systems, where he supervised the nonclinical development of monoclonal antibody therapeutics and the nonclinical bioanalytical laboratory. He has also held positions at Aton Pharma and Cato Research, and worked as pharmacology team leader at the U.S. Food and Drug Administration's Division of Oncology Drug Products. He earned his PhD in medicinal chemistry from the University of Maryland at Baltimore.