Hands-on Trainings
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 workin in a controlled, environment, aseptic technique, and how to operation 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.
Advanced Certificate in Biopharmaceutical Manufacturing
Advanced Downstream: Chromatography and TFF Process Development Methodologies
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.
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 bioanalytical tools.
Fundamentals of Quality Control
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.
Hands-on cGMP Biomanufacturing of Vectors for Gene Therapy
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.
mRNA Vaccines & Therapeutics 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.
TRIBEC 1: Overview of Biomanufacturing
TRIBEC 1: Overview of Biomanufacturing is the first self-paced, online course in a series of six planned TRIBEC Core Courses. The online TRIBEC 1 course provides an in-depth overview of the biomanufacturing industry with a focus on the production and development of biopharmaceuticals. Students will learn fundamental biological principles, explore upstream and downstream manufacturing processes, review key quality and regulatory requirements, and discover diverse career pathways in the industry.
Online Trainings
Introduction to Pharmaceutical Manufacturing
Understanding the Science of the Biopharmaceutical Industry
This asynchronous online course provides a pragmatic study in the scientific principles of microbiology, immunology, and basic biochemistry that create the foundation for developing and manufacturing biopharmaceutical products. Curriculum covers biological macromolecules, an intensive study of infectious and non-infectious diseases, the immune system’s structure and function, pathogenesis, and categories, uses, and development process of biotherapeutics and vaccines.
cGMP Procedures and Documentation
This asynchronous online course explains the expectations of and reasoning behind proper documentation protocols mandated in current Good Manufacturing Practice (cGMP) environments, like pharmaceutical production facilities. Topics include principles of data and information entry, technical writing, recording guidelines, document control, and process documentation, including laboratory notebooks, logbooks, standard operating procedures (SOPs), and batch production records (BPRs). Participants will understand the entire documentation pathway from R&D to commercialization of product, including corporate, R&D, manufacturing and qualification/validation.
Pharmaceutical Facility Operations
This asynchronous online course provides an overview of pharmaceutical manufacturing facilities, including design/layout, utilities, and equipment. Participants will study clean room design, classification, and structure, and understand the many processes that are implemented to ensure a sterile environment, including practicing aseptic technique, gowning, environmental monitoring, and sanitization. Management of chemical and biological waste, sterilization techniques, and equipment maintenance and calibration are also discussed alongside the importance of validation in a pharmaceutical facility.
Safety in the Biopharmaceutical Industry
This asynchronous online course covers a wide range of safety, health and environmental (SHE) issues specifically related to the pharmaceutical industry, including environmental safety, process and product safety, biosafety levels, industrial hygiene, and physical and chemical properties. Participants will receive an overview of product development stages and vaccine production, and will learn about toxicity, toxicology, drug safety and evaluation, pharmacokinetics and toxicokinetics, as well as risk assessment and analysis. Case studies, historically significant accidents, and lessons learned are incorporated throughout to provide real-life relevancy.
Therapeutics Manufacturing: Past, Present and Future
This asynchronous online course provides a complete review of therapeutic products manufacturing, including small molecule (chemical) drugs and large molecule biologics.