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.
For all training courses, participants should arrive around 8:30, training begins at 9 AM and concludes around 5 PM. A light continental-style breakfast and lunch are provided each day. For course that are 3 days or more, a one course dinner is served as well.
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.
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: 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.
In biopharmaceutical processing, downstream operations deal with removal of soluble and insoluble impurities including both process and product related impurities. The intent of downstream operations in biomanufacturing is to create the optimum process environment for removal of these impurities by selecting an appropriate purification strategy. This three-day course provides a basic overview to downstream operations carried out in a biopharmaceutical manufacturing setting.
Protein biopharmaceuticals have a complexity far exceeding that of small molecule drugs. The structural characteristics of these proteins, together with their stabilities have to be revealed during development and subsequently need to be closely monitored prior to clinical or commercial release. Not only the assessing these characteristics but also in demonstrating comparability, e.g., between originator and biosimilar, a significant number of analytical tools have to be employed. The training provide insights into the chromatographic, electrophoretic and immunoassay techniques most commonly used in industry for mAbs discovery, development and release.
Biopharmaceutical drug products are normally in liquid form and often are delivered to patients directly through intravenous (IV) or subcutaneous (Sub-Q) injection. As such, manufacturers are required to provide significant assurance regarding the safety of drug products since the method of delivery effectively bypasses the patient’s natural defenses against any infection caused by the drug or the device, or both.
This three-day course in intended for industry professionals working in the biopharma industry who wish to learn about basic drug substance and drug product process operations under all types of clean room, aseptic, and sterile environments.
This three-day course introduces the basic concepts and principles of pharmaceutical process validation to professional scientists and engineers who are new to the field.
Guidelines introduced by FDA and the European Medicines Agency (EMA) represent a paradigm shift in the process validation approach. These guidance documents incorporate the “lifecycle” concept into the validation process. These guidelines are not based on conformance to a fixed set of protocols, but are designed using a risk-based approach that identifies and controls potential risks within the manufacturing process.
Since its introduction by the FDA in the early 2000s, quality by design (Q-b-D) methodology has become the standard good practice in biopharma for commercialization of bioproducts. Defining and agreeing upon the critical quality attributes (CQAs) of the target product early in process development and protecting the CQAs of the product building quality in process design during development, tech transfer and manufacturing are the foundational principles of Q-b-D.
This three-day course introduces the basic concepts and principles of Q-b-D to professional scientists and engineers who are new to the field.
This introductory course provides the basic principles of mathematical and statistical methods using case studies, definitions and terms relevant to understanding how modern biopharmaceutical products are developed and marketed in a highly regulated environment. These techniques are used by industry professionals to create the foundation for ensuring that product quality, safety, and efficacy are built into process during design and not introduced as an afterthought.
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 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