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Biomanufacturing Training Education Center (BEC)

BEC - Biomanufacturing Training Education Center Courses

BEC 220 Introduction to Drug Development and Careers in Biomanufacturing 1.

Introduction to discovery and development of biopharmaceuticals, industrial enzymes, food ingredients and biologics. Discussion of majors that prepare students for positions in the biotechnology industry. Lectures from staff and from professionalsin the biotechnology industry focus on drug development, biopharmaceutical process development, design of biomanufacturing facilities, overview of methods used for manufacturing biopharmaceuticals, drug and enzyme purification, formulation, as well as careers in FDA compliance documentation related to manufacturing products using microbial biotechnology.

BEC 330 Principles and Applications of Bioseparations 2.
Prerequisite: CH 223 or CH 227.

Objectives, strategies, and approaches for recovery and purification of biomolecules, especially recombinant proteins. Description of common purification equipment, processes and materials used for cell lysis, precipitation, flocculation, membrane filtration, column chromatography, and centrifugation. Laboratories provide students with exposure to various techniques and the parameters that control protein isolation and purification of a recombinant protein. This is a half-semester course. Students who have completed BIT(CHE) 464 may not complete this course for credit.

BEC 363 Foundations of Recombinant Microorganisms for Biomanufacturing 2.
Prerequisite: BIO 183.

Introduction to basic biomanufacturing techniques with particular focus on the most commonly used recombinant microbes in industry. Includes microbial identification, metabolism, and growth kinetics; recombinant production and analysis of low molecular weight molecules, alcohols, recombinant enzymes and others. The laboratory portion of this half-semester course provides students with practical experience on basic biomanufacturing techniques carried out in small scale.

BEC 426 Upstream Biomanufacturing Laboratory 2.
Prerequisite: (MB 351 and FS 231) CHE/BEC 463.

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.

BEC 436 Introduction to Downstream Process Development 2.
Prerequisite: BEC 330 or graduate standing.

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.

BEC 440 Expression Systems in Biomanufacturing 1 3.
Prerequisite: BEC 363 or (MB 351 and MB 352).

Introduction to bacterial and yeast expression systems, their advantages and disadvantages. Basic techniques in molecular biology, cell transformation and optimization of protein expression. Selection, archiving and characterization of production line. Study of parameters affecting expression and yield. The lab portion of the course provides students with practical experience in DNA and protein expression techniques in bacterial and yeast expression systems.Credit not given for both.

BEC 441 Expression Systems in Biomanufacturing II 3.
Prerequisite: BEC 440/540 or BIT 410/510.

Introduction to insect and mammalian cell expression systems, their advantages and disadvantages. Advanced techniques in DNA cloning, cell transformation, and optimization of protein expression. Selection, archiving and characterization of production line. The lab portion of the course provides students with practical experience in DNA cloning and protein expression techniques in insect and mammalian cell expression systems. Credit not given for both.

BEC 462 Fundamentals of Bio-Nanotechnology 3.
Prerequisite: MA 241 and PY 208 and (CH 223 or CH 227).

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.

BEC 463 Fermentation of Recombinant Microorganisms 2.
Prerequisite: CH 223 or CH 227; Corequisite: (BIT 410 or BCH 452 or MB 352 or BEC 363).

Introduction to fermentation and protein chemistry. Theory behind laboratory techniques and overview of industrial scale expression systems. Laboratory sessions involve use of microbial expression vectors, fermentation systems, and large-scale purification of recombinant protein. Half semester course, first part.

BEC 475 Global Regulatory Affairs for Medical Products 3.
Prerequisite: Senior standing.

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.

BEC 480 cGMP Fermentation Operations 2.
Corequisite: BBS/BEC/FS 426.

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.

BEC 483 Tissue Engineering Technologies 2.
Prerequisite: BIT 466/566 or permission of instructor.

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.

BEC 485 cGMP Downstream Operations 2.
Corequisite: BEC 436/536.

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.

BEC 488 Animal Cell Culture Engineering 2.
Prerequisite: (CHE 447 or BEC 463 or BIT 466).

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, and single-use (disposal) bioreactors. This is a half-semester course.

BEC 495 Special Topics in Biomanufacturing 1-4.

Offered as needed to present materials not normally available in regular course offerings or for offering of new courses on a trial basis. Departmental approval required.

BEC 497 Biomanufacturing Research Projects 1-3.

Introduction to biomanufacturing research through experimental, theoretical, and literature studies. Oral and written presentation of reports. Departmental approval required. Individualized/Independent Study and Research courses require a Course Agreement for Students Enrolled in Non-Standard Courses be completed by the student and faculty member prior to registration by the department.

BEC 515 Biopharmaceutical Product Characterization Techniques 2.
Prerequisite:CH 222 or equivalent.

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.

BEC 526 Upstream Biomanufacturing Laboratory 2.

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.

BEC 532 Biological Processing Science 2.
Prerequisite: BCH 451 or graduate standing.

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.

BEC 536 Introduction to Downstream Process Development 2.
P: BEC 532 or BEC 330 or permission of instructor..

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.

BEC 540 Expression Systems in Biomanufacturing 1 3.
Prerequisite:MB 351/352.

Introduction to bacterial and yeast expression systems, their advantages and disadvantages. Basic techniques in molecular biology, cell transformation and optimization of protein expression. Selection, archiving and characterization of production line. Study of parameters affecting expression and yield. The lab portion of the course provides students with practical experience in DNA and protein expression techniques in bacterial and yeast expression systems.Credit not given for both.

BEC 541 Expression Systems in Biomanufacturing II 3.
Prerequisite: BEC 440/540 or BIT 410/510.

Introduction to insect and mammalian cell expression systems, their advantages and disadvantages. Advanced techniques in DNA cloning, cell transformation, and optimization of protein expression. Selection, archiving and characterization of production line. The lab portion of the course provides students with practical experience in DNA cloning and protein expression techniques in insect and mammalian cell expression systems. Credit not given for both.

BEC 562 Fundamentals of Bio-Nanotechnology 3.
Prerequisite: MA 241 and PY 208 and (CH 223 or CH 227).

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.

BEC 563 Fermentation of Recombinant Microorganisms 2.

Introduction to fermentation and protein chemistry. Theory behind laboratory techniques and overview of industrial scale expression systems. Laboratory sessions involve use of microbial expression vectors, fermentation systems, and large-scale purification of recombinant protein. Half semester course, first part.

BEC 575 Global Regulatory Affairs for Medical Products 3.

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.

BEC 577 Advanced Biomanufacturing and Biocatalysis 3.
Graduate standing in engineering or life-science graduate program.

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.

BEC 580 cGMP Fermentation Operations 2.
Corequisite: BBS/BEC/FS 426.

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.

BEC 583 Tissue Engineering Technologies 2.
Prerequisite: BIT 466/566 or permission of instructor.

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.

BEC 585 cGMP Downstream Operations 2.
Corequisite: BEC 436/536.

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.

BEC 590 Industry Practicum in Biomanufacturing 3.

Technical, operations, project management and regulatory compliance problems related to the design of a biomanufacturing process for cGMP manufacture of therapeutic antibodies, Fc-fusion proteins or antibody fragments to be used as human biotherapeutics. The BTEC simulated cGMP manufacturing facility will be the basis for solving problems.

BEC 595 Special Topics in Biomanufacturing 1-6.

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.

BEC 601 Biomanufacturing Seminar 1.

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.

BEC 620 Leadership and Preparation for Industry Internship in Biomanufacturing 2.

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.

BEC 621 Communicating and Industry Internship in Biomanufacturing 1.
Prerequisite:BEC 620.

Organize information learned in a biomanufacturing internship and demonstrate effective oral presentation of proprietary information. Create a professional presentation about their industry internship experience and write a paper describing their experience. Biomanufacturing Graduate Faculty evaluates each industry internship experience by student presentation and written paper. An industry internship is required of all Professional Science Masters (PSM) degree programs in the U.S. Restricted to BIOM graduate students and students applying to the BIOM program.

BEC 669 Biomanufacturing Research Projects 1-4.
Prerequisite: Graduate standing in engineering, biological science or physical science.

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.