JIB Industry Bioprocess Training Programs
The Jefferson Institute for Bioprocessing (JIB) offers a broad range of trainings to advance the skills and knowledge of scientists, engineers, and technicians who work in process development and biomanufacturing of biopharmaceuticals and biologics. Through its 25,000 sq. ft. fully flexible state-of-the-art facility, JIB is able to provide truly tactile training by combining interactive presentations, workshops, hands-on lab and pilot-scale experience.
In addition to open enrollment courses, JIB also offers customized trainings to meet industry needs by providing specialized courses developed through face-to face planning and delivered either at JIB or at the company site. JIB is the only education and training institute for biopharmaceutical processing in North America that combines a commercial scale GE FLEX Factory with the internationally recognized National Institute for Bioprocessing Research and Training (NIBRT) curriculum.
Course Overview: Scientific, engineering, and practical industrial aspects will be presented in a series of interactive presentations and workshops complemented with case studies and laboratory demonstrations in JIB. Course attendees will gain first-hand experience in principles of mammalian cell culture technologies, process development, scale up and scale down, control and measurement of dissolved oxygen, pH and temperature, setting up and running experiments, and analyzing data from high cell-density, fed-batch and perfusion cultures in lab and pilot-scale bioreactors.
Course Overview: Preparative chromatography is a critical unit operation in the biopharmaceutical industry for purification of biologics. A modern platform process for purification of monoclonal antibodies, for example, includes two or more chromatography steps. The impact of chromatography on product quality attributes and process economics is significant. Major advances in scale-up and scale-down methods combined with the introduction of new resins and column packing techniques are transforming the way chromatography columns are designed and operated.
Course Overview: This training is offered as a two-part course. Sessions are taught back-to-back. Participants can register for one or both sessions. Part 1 is not a pre-requisite for enrolling in – or learning from – Part 2.
Primary Recovery in Biopharmaceutical Processing (1 ½ day)
This 1.5 day training addresses primary recovery in the downstream processing of biopharmaceuticals including proteins and monoclonal antibodies. Topics covered will address the challenges associated with primary recovery of high cell density and low cell viability.
Tangential Flow Filtration (TFF) in Bio-manufacturing (1 ½ day)
This 1.5 day session will address the theory and practice of tangential flow filtration (TFF) including current methods and techniques for technology selection and process operation.
Course Overview: One of the major supply chain challenges in biomanufacturing is the storage and transportation of large volumes of active (bio)pharmaceutical ingredients (Bio-API). While lyophilization may be used in early phase processes, often freezing is the preferred option for late phase operation and commercial use. Freezing offers major advantages over other methods, and has widespread application despite proven difficulties in design and scale-up. Another often overlooked design challenge comes with the thawing of the frozen bulk Bio-API material prior to drug product formulation. This 3-day course provides the scientific and engineering bases for the design and scale up of both passive and active freezing and thawing of bulk Bio-API materials in a biomanufacturing setting.
Course Overview: This 3-day course will increase the skills and knowledge of anyone working directly or indirectly in biopharmaceutical and process development. Participants will gain insight into the practical challenges of working in a highly regulated industry, especially in the launching of a new biomolecule beyond candidate selection. The course will introduce the participants to standard (good) industry practice, through specific examples and case studies based on industry experience, focusing not only on success, but critically on failures.
Course Overview: This two-day course provides an introduction to the typical upstream operations carried out in a biopharmaceutical manufacturing facility. This course will include both hands-on practical and theory components. During this course trainees will be introduced to cell culturing techniques using small scale shake flasks. Trainees will then gain hands-on, practical experience using both scalable stirred bioreactors, including wave bags, as well as traditional upright mechanically agitated bioreactor including a 50L and a 200L single use bioreactor.
Course Overview: This one-day course offers an introduction to the biopharmaceutical industry and its associated processing principles and techniques to engineers and others from a non-biopharma background. The course will expand attendees’ knowledge and understanding of all aspects of the bioprocessing industry.
Course Overview: Single Use Technology is widely used within the biopharmaceutical industry and has quickly become a mainstay within the sector. The technology is very attractive as it removes much lengthy validation of the system and does not require any CIP (clean-in-place) which ultimately reduces costs by removing non-value added steps from the process and shortening drug development time. This training program will highlight the readily available technologies that can be implemented in upstream and downstream processing. It will allow trainees to gain hands on experience of common disposable technologies used in upstream and downstream processing including bioreactors, chromatography systems, UFDF systems, connects/disconnects and tube welders and sealers.
Course Overview: This one-day course is designed to provide the trainee with an introduction to microbiology and its practical application in a GMP biopharmaceutical manufacturing environment. Classroom-based lectures and hands-on practical sessions will introduce the aseptic practices of environmental monitoring and water sampling as well as the use of common microbiology lab equipment such as BSCs, microscopes and gram staining equipment.
Course Overview: This comprehensive four-day course is designed to equip new QC analysts with the main theory and practical experience required to develop their skills in the microbiology laboratory. Classroom-based lectures on microbiology basics and the main aspects of contamination control will introduce the various hands-on sessions over subsequent days, covering basic micro culturing techniques, IDs and use of microscopes, water and in-process testing methods of bioburden and endotoxin/sterility testing for support of manufacturing and utilities, as well as validation tests such biological indicators. The course will also focus the use of Quality Management Systems, GxP Audits and Regulations.
Course Overview: This three-day course guides trainees through the Critical Quality Attributes of biologics (ICH Q6B) as well as core analytical platforms routinely employed in a QC testing environment in order to measure them. Using a combination of lecture sessions and hands-on practical training, the course will cover methods such as electrophoretic separations (capillary electrophoresis, slab gels), HPLC/UPLC methods (peptide mapping, SEC, etc), and immunoassays (ELISA).
INDUSTRY COURSE OFFERINGS
- Upstream and Downstream Operations
- Scale Up/Scale Down
- Quality and Regulatory Compliance
- Continuous Bioprocessing
- Single Use Technologies
- Quality by Design and Design of Experiments
- Process Modeling and Process Integration
- Analytical Methods and Applications
- Process Tech Transfer, Qualification, and Validation
- Aseptic Process and Cleaning Operations