This intensive hands-on workshop bridges the gap between AI capabilities and regulatory reality in life sciences manufacturing. Participants will gain practical knowledge of how large language models work, learn to design AI systems appropriate for GxP environments, and develop validation strategies that satisfy regulatory expectations. Through a combination of instruction and collaborative design workshops, attendees…

Obtain knowledge and hands-on experience with industry-relevant process control instrumentation, hardware, and software, and documentation for control/automation of biomanufacturing operations. Engage in hands-on experiences with process sensors/equipment and their integration with a control system for enacting control strategies. Learn how to connect process equipment and I/O interfaces for use with a commercial control software package.

A well-packed chromatography column is critical to chromatographic separations at benchtop- and industrial-scales alike. Low-quality chromatography column packing can cause uneven mobile phase distribution and poor stationary phase contacting, ultimately leading to lower yields, less separation, and reduced product quality. This course is offered in collaboration with Bio-Rad Laboratories, Inc.

Spray drying is used in pharmaceutical manufacturing to rapidly remove solvent from drug products to improve stability and enable additional routes of administration. In this one-day hands-on course, you will learn the principles of spray drying and dried powder analysis. Specific concepts such as atomization, heat transfer, material characterization, and critical parameters for process optimization…

This course provides participants with fundamental knowledge of cutting-edge cloning strategies essential for mammalian cell line development, specifically geared towards protein overproduction with specific quality attributes. With a focus on the industrial-relevant Chinese hamster ovary (CHO DG44) cells as the expression model, attendees will delve into crucial aspects such as the selection of expression vectors,…

Attend this course to gain a fundamental understanding of successful bioanalytical assay development and validation. This course is composed of primarily hands-on activities with some lecture. You’ll get hands-on experience with designing and developing assays, then validating them by considering ICH guideline Q2(R1). You’ll gain an appreciation for the complexities involved in biopharmaceutical analysis and…

Learn the principles of fermentation and engineering fundamentals for growing production microorganisms in a bioreactor to express recombinant proteins. Gain a working understanding of essential unit operations for bioreactor cleaning as well as vessel and medium sterilization. Sample and monitor pilot scale bacterial fermentations for cell density and product formation. Engage in hands-on laboratory experiences…

Gain a deeper understanding of the fundamentals of recovery and purification operations for biopharmaceutical production and how these operations are designed for use at production scale. This course provides both theoretical and practical insight through lectures and laboratory activities.

Take this course to experience a 3-day, hands-on, overview of AAV Quality Attributes. Step through each CQA category, Identity, Quantity, Potency, Purity and Safety through interactive lectures, group workshops, and hands-on labs in BTEC’s state of the art facility. All course content is directly related to current applications in industry while providing basic theory to…