Obtain a basic knowledge of biomanufacturing operations and how CGMP requirements are implemented at commercial scale. Engage in pilot-scale laboratory experiences that examine process utilities, media and solution preparation, bioreactor operation, centrifugation, chromatography, and tangential flow filtration in a simulated commercial CGMP (current Good Manufacturing Practice) facility.
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…
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.
mRNA technology is transforming the landscape of modern medicine, driving innovations in vaccines and various therapies. The demand for skilled professionals who understand mRNA design, synthesis, and manufacturing has grown rapidly. This course provides a practical foundation in the science and production of mRNA therapeutics, preparing participants to contribute to this fast-evolving and impactful field.
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…
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…
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,…
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…
Lyophilization (freeze drying) is used in biomanufacturing processes to remove solvent from drug products and improve stability. In this two-day hands-on course, you will learn the principles of biopharmaceutical lyophilization, process development, and dried product analysis.
This two-day intensive course presented by invited industry experts covers industry practices, regulatory expectations, and trends in cleaning and cleaning validation. It is designed for biopharmaceutical manufacturers who are concerned about developing or maintaining a high-quality, efficient, and most importantly, compliant cleaning process. The training addresses several current challenges to cleaning and validation in the…
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.
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.