第一天: 1:00 – 5:00 pm | 第二天: 8:00 am– 5:00 pm
TS1A: Introduction to Bioprocessing
Sheila G. Magil,
Frank J. Riske,
CHI’s Introduction to Bioprocessing training seminar offers a detailed survey of the steps needed to produce today’s complex biopharmaceuticals, from early development through commercial. The seminar begins with an introduction to biologic drugs and the aspects of protein science that drive the progression of analytical and process steps that follow. Then, step through the stages of bioprocessing, beginning with the development of cell lines and ending at scaling up for commercial production. Also explore emerging process technologies, facility design considerations and the regulatory and quality standards that govern our industry throughout development. The important roles of analytical methods at all stages of development as well as formulation and stability assessments in developing and gaining approval for a biopharmaceutical are also examined.
TS2A: Regulatory Requirements across the Product Development Lifecycle
The successful development of a pharmaceutical product requires not only good
TS3A: Introduction Quality by Design (QbD) for Biopharmaceuticals
Naveen Pathak, Director, Pharmaceutical Science, Takeda
The application of a Quality by Design (QbD) methodology for product commercialization is increasingly becoming the standard business practice at Pharma and Biotech companies. QbD elements such as Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and Control Strategy are also required by US, EU
TS4A: Intro to Gene Therapy and Viral Vectors
In the age of gene therapy, there is a significant demand for scientists trained in the “dark arts” of viral vector production and analysis. This
第一天: 8:00 am – 6:00 pm | 第二天: 8:00 am – 12:15 pm
TS5B: Introduction to Analytical Method Development and Validation for Biologics Products
Jichao (Jay) Kang,
This course is a panoramic review of analytical method development and validation for Biologics products, including antibodies, enzymes and gene therapy products. It starts with basic knowledge of work on biologics: manufacturing, regulatory affair knowledge, and essential technical knowledge. It then discusses fundamentals and practical aspects of commonly used analytical methods for biologics, including methods for structure elucidation, glycan characterization, biophysical characterization, potency measurement, purity and impurity analysis. The course concludes with the strategy and common practice in method validation and method transfer, including regulatory compliance at different stages of product development, application of DOE and QbD. The course emphasizes practical applications, real-world examples, and useful tips.
TS6B: Bioprocess Strategies from Development to BLA
Instructor: Sheila G. Magil,
Today’s biopharmaceutical development environment is driven by a constant stream of new modalities and product formats, an increased focus on product quality and management imperatives to advance through clinical development rapidly, and at the lowest possible cost. The Bioprocess Strategies training seminar presents a look at the key timelines and strategic considerations during the
第一天: 1:30 – 5:00 pm | 第二天: 8:30 am – 3:30 pm
TS8C: Introduction to Biologics Formulation Development
Donald E. Kerkow,
In this training, you will learn strategies to plan and execute
TS9C: Design of Experiments for Cell and Gene Therapies
Design of Experiment (DOE) is recognized as the most prominent tool for analyzing the effect of multiple factors on complex unit operations. Cell and gene therapy manufacturing processes contain many classic examples of such operations, and DOE is the best systematic approach for their optimization. This results in improved manufacturing yields, efficiency, cost, consistency
TS10C: Protein Aggregation and Formulation Optimization
Molecular interactions are central to protein discovery, development
What is a Training Seminar?
Each Training Seminar offers 1.5 Days of instruction with start and
Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed no additional books will be available.
Though CHI encourages track and symposia hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and NOT engaging in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.