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MBI 406 : Biomanufacturing

Course for undergraduates, graduate students and postdocs (Fall Semester)cGMP wave bioreactor

The Upstate cGMP facility has also an Educational mission to ensure training of students to become the next generation of leaders in Biomanufacturing and Drug Development teaching the MBI 406 BIOMANUFACTURING course as part of the MS in TEAM-BMTD being Dr. Tracey Baas the TEAM Program Director. The instructor of MBI 406 is Luisa Caetano-Davies, the USCGF Facility Executive Director.

MBI 406-Biomanufacturing scope:

MBI 406 BIOMANUFACTURING gives an introduction to current aspects of manufacturing of cell-based therapies and biopharmaceuticals using industrial techniques and commercially relevant bioprocesses, thus training students by leveraging their experience, creating a highly skilled pool of interns for GMP facilities, and helping students to transition from academia to industry.

  • MBI 406 provides an overview of cell-based therapeutic products that treat or prevent human disease like viral vectors, monoclonal antibodies, vaccines, cancer immunotherapy, ESC and iPSC derived specialized population for allogeneic or autologous transplants. Processes related with their manufacture such as scale-up, chromatography, fermentation, cell culture, bioreactors and in-process testing to yield products that are safe, pure and potent. Specific lectures will discuss biomanufacturing background, quality assurance, regulations, procedures, proper techniques and documentation.
  • The cGMP facility will be toured to show an example of a fully validated biomanufacturing facility for the production of therapy products.

MBI 406-Biomanufacturing syllabus:


Syllabus 2019:

2019 Course syllabus (Luisa Davies)

Previous years:

2018 course syllabus (Instructor: Luisa Davies)

2017 course syllabus (Instructor: Luisa Davies)

2016 course syllabus (Instructor: Mike Fiske)

Class 2019

GowningStudents 2019







GMP studentsGMP students

MBI 406-Biomanufacturing may include invited speakers from:

INDUSTRY: Bristol Mayer Squibb, Novozymes, BioGreen Consulting, Vaccinex, GE-Healthcare, Gencure, Athersys, Torque Therapeutics, Athenex, Alkermes, Takeda, Telephus Bioscience

cGMP FACILITIES: UC Davies GMP Facility, Biomanufacturing Training and Education Center (BTEC)

UNIVERSITY: Biomedical Engineering-Cornell University, Regulatory Affairs-URMC, Quality Assurance-URMC, Biomedical Genetics-URMC

INTERNSHIPSGMP checkercGMP microscope

Each year the facility helps students to pursue a scientific career or degrees by providing them with opportunities to work side by side with scientists and technicians at the Upstate cGMP facility.


The Upstate cGMP Facility enables tours for High Schools and University students, as an example of a fully validated biomanufacturing facility for the production of therapy products for clinical trials, and at the same time sharing academic-level experience to inspire students to pursuit a scientific degree and career.


Luisa Caetano Davies

Luisa Caetano-Davies
Executive Director, Upstate Stem Cell cGMP Facility