James McIver Ph.D., joined Biologics Consulting Group, LLC (BCG) as a
senior consultant in July 2003.

Dr. McIver has more than 25 years of experience in biologic product research, development, manufacturing and quality systems as Assistant Director at the Massachusetts Biologic Laboratories (MBL). His responsibilities over the years at MBL included four years as Director of Quality; followed by twenty years as Director of therapeutic immunoglobulin and plasma fractionation research, development and production. While at MBL, Dr. McIver's specific academic and research interests led to the development of process technology for manufacturing several intravenous immune globulin and hyperimmune globulin products. He also served as project director to design, implement construction, initiate the startup and complete the validation for a new Cohn/Oncley cold ethanol cGMP production facility. Batching, reagent addition, ethanol addition, temperature control, mixing, and equipment CIP is fully automated with batch record data recording. The fully validated computer controlled facility served as a model for establishing technology transfer agreements with four FDA licensed manufacturing facilities.

He has experience in all phases of cGMP GLP compliance, technology transfer and validation. He has experience in preparation of documents for product development, process validation, viral clearance validation, and manufacturing sections of IND, PLA, and ELA applications. In addition, Dr. McIver's experience includes cGMP manufacturing of monoclonal antibody products and direct experience with cell culture and purification methods.

Dr. McIver recently served as a founding member of the combined FDA/PDA Taskforce for the Validation of Cold Ethanol Purification Methods. These efforts included preparation of a consensus technical document for process validation methods and the organization of two PDA/FDA workshops. He served as a member of the US Army/Department of Defense Botulism Immune Globulin Expert Working Group. Responsibilities included review and consultation for botulism immune globulin research, development, manufacturing and clinical studies.

Dr. McIver obtained his Ph.D. in Immunology from Tufts University School of Medicine, Boston, MA. He maintains an academic position of Assistant Professor of Medicine at Tufts University Medical School (1982-present) and also held the appointment of Associate Professor of Medicine at the University of Massachusetts Medical School. He has authored or co-authored 25 scientific papers and authored a textbook chapter on Immunoglobulin preparations. He has presented papers on manufacturing technology and validation strategies at PDA/FDA workshops.

Before joining the Biologics Consulting Group, Dr. McIver served as a consultant in the fields of therapeutic immune globulins, human plasma protein purification, fibrin clotting, platelet clotting, blood products, molecular separations, and bioreactor culture of monoclonal antibodies.

View Jim McIver's Curriculum Vitae...

Page Updated April 26, 2007