Other Services - Consulting, Protocol Development, and IRB Submissions

Key Biologics offers expert consulting services in the development, management, and submission of a sponsor's research protocol to an IRB. From the time we receive the sponsor’s protocol, it generally takes approximately one month to receive IRB approval and initiate collections.

Examples of IRB-approved research studies that we have supported include:

• Recruitment, screening and enrollment of normal subjects and collection of mobilized mononuclear cells for use in production of allogeneic clinical therapeutic for Phase I trial.

• Recruitment of normal subjects and collection of non-mobilized mononuclear cells for use in cell processing device qualification and validation.

• Recruitment of subjects with history of melanoma (Grade II) and collection of non-mobilized mononuclear cells for use in preclinical studies of melanoma vaccine.

• Recruitment of subjects with HIV infection (anti-retroviral experienced with defined viral load) and collection of non-mobilized mononuclear cells for use in process qualification of HIV vaccine.

• Recruitment of subjects with acute HCV infection (NAT positive and HCV-antibody negative) and collection of whole blood and non-mobilized mononuclear cells for investigation of HCV mediated immune responses.

• Recruitment of normal subjects and collection of non-mobilized mononuclear cells for use in preclinical studies of a cancer vaccine.

• Recruitment of subjects with HSV-2 infection and collection of leukocytes for use in preclinical studies of a therapeutic HSV-2 vaccine.

• Recruitment of normal subjects with specified HLA class II typing for use in preclinical development of cancer vaccine.

• Recruitment of normal subjects and plateletpheresis collections for support of an IDE study of a revision of cell collection device software.

• Recruitment of normal subjects and collections of non-mobilized mononuclear cell products for support of an IDE study of a new cell collection device.

• Recruitment of normal subjects and collections of G-CSF mobilized mononuclear cell products for support of an IDE study of a new cell collection device.