This 8 week graduate course introduces engineering students to bioanalytical testing to processes that produce structurally complex biopharmaceuticals. Students will gain hands-on experience including assay validation, drug/biologic substance characterization (structural and activity) and biopharmaceutical purity. The technologies and related theory will include rapid micro SDS-PAGE, lab-on-a-chip, HPLC, mass spectrometry, UV/Vis absorbance and fluorescence spectroscopy. Students will also learn assay development and validation concepts as per ICH Q2(R1) and other U.S. and international government regulatory guidelines.

Prerequisite:CH 222 or equivalent

Typically offered in Fall only

This course is an introduction to fundamental molecular biology techniques, applied to generate bacterial cell lines for the production of recombinant proteins. Course material provides a comprehensive description of an expression system, with emphasis on the central dogma of molecular biology, detailed gene structure, vector components and bacterial host cell characteristics. Different genetic, physiologic and growth condition aspects are included to ensure the overproduction of a functional protein of interest. This comprises different molecular approaches for gene cloning, bacterial selection/screening and regulation of genetic expression. The course provides hands-on experience during laboratory sessions, where students isolate a gene of interest, clone the gene into an expression vector, transform bacteria, select for positive clones, grow recombinant cells, and induce the production of the protein of interest. Techniques such as SDS-PAGE, Western blot, and ELISA are used for the detection and quantification of the active recombinant protein.

Prerequisite: BIO 183 or equivalent

Typically offered in Fall and Spring

This course is an introduction to current food manufacturing practice (CGMP) as applied to the growth of microbial cells in bioreactors. Hands-on experience is obtained in the operation and control of 30 liter bioreactors to study agitation, oxygen transfer, cleaning, sterilization, media preparation and the growth of recombinant E. coli for protein production. Credit will not be awarded in both BBS 426 and BBS/FS 526. This is an eight week course.

Prerequisite: (MB 351 and FS 231) CHE/BEC 463

Typically offered in Fall and Spring

Fundamental scientific principles underlying the recovery, purification and formulation of biologics (biotherapuetics), especially proteins, are examined. Emphasis is placed on delineating the key chemical and physical properties of biomolecules that impact processing and formulation development. Laboratories in the analytical and small-scale purification facility provide students with 'hands-on' exposure to key scientific principles and small scale unit operations. This is a half-semester course.

Prerequisite: BCH 451 or graduate standing

Typically offered in Fall and Spring

Objectives, strategies, and approaches for recovery and purification of biomolecules, especially recombinant proteins. Laboratories in the intermediate-scale pilot plant provide students with exposure to various unit operations and the parameters that control protein isolation and purification of a recombinant protein produced by an E. coli. This is a half-semester course. Students who have completed BEC 436 may not take BEC 536 for credit.

Prerequisite: BEC 330 or graduate standing

Typically offered in Fall and Spring

This course provides the basic and advanced principles of genetic engineering in yeast and mammalian cells for the overproduction of a protein of interest. Students will use classical and novel strategies to establish a stable Chinese hamster ovary (CHO) cell line based on the industrially relevant strain, DG44 (DHFR system). Students will also generate a yeast expression system based on Pichia pastoris for the production of the same protein. The generation of two different cell lines for the overproduction of the same protein of interest should provide students with an appreciation of each system in terms of cost, speed, productivity and product quality.

Corequisite: BEC 425/525 or Prerequisite: BIT 410/510 or MB 351 or MB 352 or MB 354

Typically offered in Fall and Spring

This course will cover critical aspects of bioreactor design, including design of reactors for enzyme-catalyzed reactions, fermentation of microorganisms, and scale-up considerations for bioreactors. Hands-on experiments involving fermentation of microorganisms and scale-up of bioreactors will be included. Students cannot get credit for both CHE 448 and CHE 548.

Prerequisite CHE 446 or instructor permission; Co-requisite BCH 451 or instructor permission

Typically offered in Spring only

Concepts of nanotechnology are applied in the synthesis, characterization, recognition and application of biomaterials on the nanoscale. Emphasis will be given to hands-on experience with nanostructured biomaterials; students will also be familiarized with the potential impact of these materials on different aspects of society and potential hazards associated with their preparation and application.

Prerequisite: MA 241 and PY 208 and (CH 223 or CH 227)

Typically offered in Spring only

Students completing this course will be able to conduct small-scale fermentations of recombinant microorganisms as well as having an understanding of ways to approach optimization of such processes. One of the focus areas of this course is on protein production and factors that affect gene expression and recombinant protein yield.

P: CH 223 or CH 227; C: BIT 410 or BIT 510 or BCH 452 or MB 352 or MB 354 or BEC 425 or BEC 525

Typically offered in Fall and Spring

The course discusses conventional and advanced drug delivery methods and systems and modern practices in drug delivery manufacturing.

P: CH 221 or CH 225 AND MA 131 or MA 141

Typically offered in Spring only

This lecture-based course introduces students to the quality systems used to meet the regulatory requirements for developing, testing, manufacturing, and selling medical products in the global marketplace. It provides a general background for those going into the medical products field, but is especially useful to students preparing for a career in the Regulatory Affairs or Quality Assurance Department within a pharmaceutical, biomanufacturing, or medical device company. BEC 575 students must have graduate standing.

Prerequisite: Senior standing

Typically offered in Fall and Spring

Overview of biomanufacturing using microorganisms (bacteria, yeast, fungi), eukaryotic cells (hybridomas, insect, plant, CHO) and recombinant enzymes focusing on methods used in industry. Course will emphasize process design for optimization of heterologous protein expression, metabolic/cell line engineering, metabolomics, protein engineering to alter enzymes and antibodies. Pathway engineering strategies include developing microbes to produce new therapeutic compounds or overproduce primary metabolites, antibiotics, biotherapeutics, therapeutic enzymes, diagnostics, recombinant vaccines, and biopharmaceuticals. Utilization of immobilized biocatalysts, and microbial kinetics are covered.

Graduate standing in engineering or life-science graduate program

Typically offered in Spring only

Application of microbial fermentation techniques at production scale and evaluation of the inherent issues resulting from the integration of microbial fermentation unit operations, scale-up/production, and current Good Manufacturing (cGMP) compliance. Lectures prepare students for pilot-scale laboratory experiences in media preparation, bioreactor operation, process utilities, and manufacturing quality systems that simulate microbial cell growth and product expression in a commercial cGMP facility. This is a half-semester course. Students who have completed BEC 480 may not take BEC 580 for credit.

Corequisite: BBS/BEC/FS 426

Typically offered in Fall and Spring

In this half-semester laboratory module, students will gain practical experience with two key elements of tissue engineering: tissue building and angiogenesis. Using advanced culture techniques, students will construct a complex living tissue that closely resembles its natural counterpart, then assess its ability to support ingrowth of capillaries (angiogenesis). The effects of different biomaterials and angiogenic factors will be evaluated. The engineered tissue will be embedded, sectioned and stained for histological analysis.

Prerequisite: BIT 466/566 or permission of instructor

Typically offered in Fall only

Application of downstream bioprocessing techniques at production scale and evaluation of the inherent issues resulting from the integration of recovery and purification unit operations, scale-up/production issues, and current Good Manufacturing Practice (cGMP) compliance. Lectures prepare students for pilot-scale laboratory experiences in cell removal, cell disruption, purification, and manufacturing quality systems that simulate downstream bioprocessing in a commercial cGMP facility. This is a half-semester course. Students who have completed BEC 485 may not take BEC 585 for credit.

Corequisite: BEC 436/536

Typically offered in Fall and Spring

Design and operation of animal cell culture bioreactors for therapeutic protein production. Topics include: batch, fed-batch and perfusion bioreactors, agitation and aeration for mixing and oxygen mass transfer, bioreactor monitoring and control, optimizing bioreactor performance, single-use [disposal] bioreactors, and the production of gene therapy vectors. This is a half-semester course. Time outside of the regularly scheduled class time may be required.

Prerequisite: BEC 463 or CHE 563 or BEC 363 or BEC 440/540 or BEC 441/541 or equivalent; or consent of instructor.

Typically offered in Spring only

This is an industry case study course emphasizing scientific, engineering, analytical, and professional skills related to biomanufacturing of human therapeutics; the course will provide students with the opportunity to design a complete cGMP process and facility capable of licensure.

Typically offered in Fall only

This online lecture-based course introduces students to upstream and downstream biomanufacturing for the production of biopharmaceuticals. The course will provide students with key upstream fermentation and cell culture concepts used by biomanufacturing industries including microbial growth, bioreactors, process controls, etc. Downstream concepts include separations, homogenization, chromatography, and ultrafiltration. There will be a specific focus on scale-up and cGMP operations for both upstream and downstream unit areas. This is a full-semester course offered in the fall only.

P: BIO 183 and CH 221 or 225

Typically offered in Fall only

Offered to present graduate course content not available in existing courses or for offering of new graduate courses on a trial basis. Departmental approval required.

Weekly seminars on topics of current interest in biomanufacturing and affiliated subjects. Seminars will be presented by resident faculty members, graduate students and visiting lectures from industry, government regulatory agencies such as the FDA or from academic programs related to biomanufacturing.

Typically offered in Fall and Spring

Offered to present graduate course content not available in existing courses or for offering of new graduate courses on a trial basis for S/U courses. Departmental approval required.

Typically offered in Fall, Spring, and Summer

Advanced communication skills specific to the regulatory requirements of the biomanufacturing and biopharmaceutical industries regulated by the U.S. FDA. Instructors teach writing professional and technical resumes, advanced interview skills, team or project leadership, teamwork and communication skills required by industry to prepare and present discipline-specific documents to the FDA. Students learn change management in a biopharmaceutical company and how to develop emotional intelligence. Interviews by industry professionals give each student experience and feedback. Restricted to students with graduate standing.

Typically offered in Spring only

Introduction to biomanufacturing research through experimental, theoretical and literature studies under the mentorship of a member of the graduate faculty. Oral and written presentation of reports. Deptartmental approval required.

Prerequisite: Graduate standing in engineering, biological science or physical science

Typically offered in Fall, Spring, and Summer