Hands-On Training Course Details

While there are no formal prerequisites for any of our courses, 1-2 years of experience in the biomanufacturing industry or completion of the Biopharma Bootcamp course is recommended. To receive CEUs and a completion certificate for this course, participants must be present for >90% of the course.

Biopharma Bootcamp

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 ion exchange chromatography, hydrophobic interaction chromatography, and column cleaning and sanitization.

Target Audience
Individuals seeking an understanding of the primary unit operations and process of biologics manufacturing.

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 3.5 Continuing Education Credits (CEU’s).

Register for the Biopharma Bootcamp

Advanced Certificate in Biopharmaceutical Manufacturing

Participants of this program complete NCTM online courses, then attend 2 weeks of hands-on training at NCTM. This course provides lectures and hands-on lab activities of upstream, downstream, and analytical operations within the biomanufacturing industry. Participants will learn how to work 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 plating, bioreactor assembly, culture media preparation, seed culturing, sterilization, inoculation, batch cultivation, and harvesting. Participants will also learn a series of downstream techniques to purify protein by performing homogenization, centrifugation, solution preparation, sterile filtration, tangential flow filtration, column packing, column cleaning and sanitization, ion exchange chromatography, and hydrophobic interaction chromatography. Finally, participants will perform a small set of analytical techniques including OD and metabolite measurements, BCA assay, and membrane integrity testing.

Online courses required include 1101/1201, 1102, 1103, 1104, and 1105. See pages 39-48 for
additional details. Course cost includes enrollment in online courses and hands-on component.

Target Audience
Entry level biomanufacturing technicians who want an overview of all aspects of the manufacturing process, while having an interest in earning a certificate.

Course Calendar
Contract training cohort of 6-12 participants as available upon request

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 9.6 Continuing Education Credits (CEU’s).

Register for the Advanced Certificate in Biopharmaceutical Manufacturing

Advanced Downstream: Chromatography and TFF Process Development Methodologies

In this course we will cover advanced topics in downstream processing. Chromatography will be 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 will be executed to demonstrate process optimization, and scale up calculations will be performed. Tangential flow filtration (TFF) will also be covered. Process development methodology for TFF will be covered, as well as other related topics including membrane cleaning and lifetime studies.

Target Audience
Industry professionals who are looking to deepen their knowledge about downstream processing, learning about process development and optimization for chromatography and Tangential Flow Filtration.

Course Calendar
Contract training cohort of 6-10 participants as available upon request.

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 2.3 Continuing Education Credits (CEU’s).

Register for the Advanced Downstream: Chromatography and TFF Process Development Methodologies Course

Advanced Upstream Processes: Design and Optimization

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 metabolite analyzer and cell counters.

Target Audience
Industry professionals who are looking to deepen their knowledge about upstream processing, going in depth about feeding strategies and optimization, process control, and scale up for fermentation and cell culture in a variety of bioreactors (single use, stainless steel, wave platform, and stirred tank).

Course Calendar
Contract training cohort of 6-10 participants as available upon request.
*Available in an abbreviated and modified version at NCTM2 location

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 3.8 Continuing Education Credits (CEU’s).

Register for the Advanced Upstream Processes: Design and Optimization Course

Fundamentals of Quality Control

This 3.5 day hands-on short course provides an overview and hands-on lab activities of general quality control operations within the biomanufacturing industry. Participants will learn about the regulatory requirements, environmental monitoring, aseptic technique, documentation and how to operate basic QC laboratory equipment.

Participants will also learn a series of QC analysis techniques, perform a selection of them in the lab and analyze the results. By the end of the course, participants will be able to understand regulatory requirements to quality control operations and documentation practices, perform environmental monitoring and aseptic techniques, operate basic QC laboratory equipment, and conduct core QC analytical methods in order to support compliant quality control operations within the biomanufacturing industry.

Target Audience
Entry level employees or individuals transitioning into QC.

Course Calendar
Contract training cohort of 6-12 participants as available upon request.

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M
Engineering Experiment Station Completion Certificate and 2.7 Continuing
Education Credits (CEU’s).

Register for the Fundamentals of Quality Control Course

Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy

This 4-day continuing education course provides 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 scaleup 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, such as qPCR and SDS-PAGE, as well as discuss strategies and issues around scale-up, tech transfer, and adherent vs. suspension cultures.

Target Audience
Industry professionals who have some background in traditional biomanufacturing and are interested in expanding their knowledge on viral vectors and gene therapy applications.

Course Calendar
Contract training cohort of 6-10 participants as available upon request.

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 3.7 Continuing Education Credits (CEU’s).

Register for Hands-on cGMP Biomanufacturing of Vectors for Gene Therapy Course

mRNA Vaccines & Therapeutics Course

In this course we cover topics related to the manufacturing of mRNA vaccines in a simulated cGMP environment. Participants will perform manufacturing unit operations and quality control testing of a model mRNA vaccine. Laboratory modules will utilize bench scale unit operations to establish process parameters. Participants will then get hands-on experience with commercial scale equipment for the in vitro transcription reaction, chromatography and UF/DF unit operations. This course also provides participants with hands-on QC testing to supplement learning on drug substance and drug product critical quality attributes and release testing.

Target Audience
Industry professionals with experience in biomanufacturing who are interested in the new modality of mRNA vaccine and therapeutics manufacturing and quality control testing.

Certificate received upon successful completion
Participants that successfully complete the course will receive a Texas A&M Engineering Experiment Station Completion Certificate and 3.7 Continuing Education Credits (CEU’s).

Register for the mRNA Vaccines & Therapeutics Course