Biomedical Engineering

This week-long, hands-on short course provides an overview and hands-on lab activities of general, upstream and downstream operations within the biomanufacturing industry. Participants will learn about working in a controlled environment, aseptic technique, and how to operate basic laboratory equipment. Participants will then produce a model protein during a series of upstream activities including bioreactor assembly, culture media preparation, batch cultivation, offline analysis and harvesting. Participants will also learn a series of downstream techniques to purify protein by performing buffer preparation, tangential flow filtration, column cleaning and sanitization, ion exchange, and hydrophobic interaction chromatography.

Register for the Biopharma Bootcamp

The Advanced Certificate in Biopharmaceutical Manufacturing immerses participants in a rigorous digital and hands‐on training program, comprised of nearly 100 hours of cGMP‐ and regulatory‐based curricula. Subject matter includes aseptic microbial and mammalian cell processing using fixed and single‐use fermentation and purification systems, regulatory compliance, quality assurance and control, process and environmental monitoring, and proper documentation and laboratory practices. Students will complete 5 self‐paced online courses, then participate in 2 weeks of hands‐on training at NCTM. Participants will receive 9.6 continuing education units and a certificate upon completion.

Fill out the Interest form for the Advanced Certificate in Biopharmaceutical Manufacturing Course

In this course, we cover advanced topics in downstream processing. Chromatography is covered in great detail, ranging from fundamental principles of mass transport within chromatography equipment to determining operating conditions for chromatography runs based on the resin selected. Process development studies are executed to demonstrate process optimization, and scale-up calculations will be performed. Tangential flow filtration (TFF), process development methodology for TFF, and other related topics, including membrane cleaning and lifetime studies, will be covered.

Fill out the Interest Form for the Advanced Downstream: Chromatography and TFF Process Development Methodologies Course

This 5-day, hands-on course will cover basic cell culture and fermentation techniques; principles of scale up and optimization for large scale cell culture and fermentation; Single use bioreactor set-up, operation and maintenance; 100 Liter bioreactor operation; Continuous flow disc stack centrifuge operation; PID control loops; Feeding strategies; and maintenance and operation of bioanalytical tools.

Fill out the Interest Form for the Advanced Upstream Processes: Design and Optimization Course

This three and a half day, hands-on short course provides an overview and hands-on lab activities of general quality control operations within the biomanufacturing industry.

Fill out the Interest Form for the Fundamentals of Quality Control Course

Receive hands-on training in the production of vectors for gene therapy products using an AAV2-GFP model system in a Sf9/Baculovirus system. Engage in upstream operations (suspension cell culture, vector production scale-up in single-use bioreactors); downstream operations (cell lysis, product recovery via depth filtration, purification using chromatography, and ultrafiltration for concentration and buffer exchange); and analytical technologies, as well as discuss strategies and issues around scale-up, tech transfer, and adherent vs. suspension cultures.

Fill out the Interest Form for Hands-on cGMP Biomanufacturing of Vectors for Gene Therapy Course

This 5-day, hands-on course will cover the basics of RNA vaccine manufacturing including in vitro transcription for mRNA production, chromatography for purification, production of mRNA-LNPs, tangential flow filtration for formulation, and QC analysis of mRNA and mRNA-LNPs.

Fill out the Interest Form for the mRNA Vaccines & Therapeutics Course

This workshop is designed for downstream processing scientists with little or no prior experience in Multi-Column Chromatography (MCC). Through a highly interactive short course, you will gain hands-on experience by transferring a batch method to an MCC process, optimizing it, and scaling it up.

Fill out the Interest Form for the Mastering Multi-Column Chromatography: From Fundamentals to Process Scale Course

The Texas Regional Industrial Biomanufacturing Education Credential (TRIBEC) Online Core Courses are asynchronous online courses providing the foundation of the program, equipping participants with a general understanding of biomanufacturing and pharmaceutical manufacturing processes, operations, and facilities, current Good Manufacturing Practices (cGMP), potential career options in the field, and a working knowledge of terminology used in the industry.

• TRIBEC 1: Overview of Biomanufacturing
• TRIBEC 2: Safety in Life Sciences Manufacturing
• TRIBEC 3: Quantifying Bioprocesses
• TRIBEC 4: cGMP Procedures and Documentation
• TRIBEC 5: Pharmaceutical Facility Operations

Each course will be a separate session and will require a session confirmation email with a link to the course in Canvas. Sessions can be registered independently or as a package.

Register for the Texas Regional Industrial Biomanufacturing Education Credential (TRIBEC) Online Core Courses

The Pharmaceutical Industry Offerings series is a collection of six asynchronous online courses designed to provide a comprehensive understanding of pharmaceutical and biopharmaceutical development, manufacturing, quality, safety, facilities, and therapeutic product production. Together, the courses cover topics including drug discovery and commercialization, microbiology and immunology foundations, cGMP documentation practices, pharmaceutical facility operations, safety and environmental considerations, and the manufacturing of both small-molecule drugs and biologics.

• Introduction to Pharmaceutical Manufacturing
• Understanding the Science of the Biopharmaceutical Industry
• cGMP Procedures and Documentation
• Pharmaceutical Facility Operations
• Safety in the Biopharmaceutical Industry
• Therapeutics Manufacturing: Past Present and Future

These courses are designed to complement one another and can be completed as a full learning pathway for a broad understanding of the pharmaceutical industry. However, each course also functions as a standalone offering, allowing participants to select individual topics that align with their specific professional interests, training needs, or career goals.

Register for Pharmaceutical Industry Offerings series

This course examines how human error impacts the safety and quality of operations in biomanufacturing processes. Reason’s error classification model and the Skill-Rule-Knowledge behavioral modes are reviewed in order to highlight how individual breakdowns may lead to error within a system. Case studies are presented to illustrate how environmental and human factors, such as workload, stress, and time pressure interact to significantly alter the outcome of processes. Discussion of strategies including error prediction and analysis, operator practices and training, and system design is included to explore how biomanufacturing systems can be built safer and more resilient.

Register for the Human Error and Resilience in Biomanufacturing Systems Course