Introduction to Bioprocessing
Sheila G. Magil, PhD, Principal Consultant, BioProcess Technology Consultants, Inc.
Frank J. Riske, PhD, Senior Consultant, BioProcess Technology Consultants, Inc.
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.
Regulatory Requirements across the Product Development Lifecycle
Christina Vessely, PhD, Senior Consultant, Analytical and Formulation Development, Biologics Consulting
The successful development of a pharmaceutical product requires not only good science, but also compliance with FDA regulatory expectations. This course will include a comprehensive review of the Chemistry, Manufacturing and Controls (CMC) section of regulatory filings, with a focus on phase appropriate requirements. The level of detail that must be included in the filing will be discussed as well as systems and controls that must be in place in the manufacturing setting. Topics such as process development, analytical development, Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) will be discussed in the context of the stage of drug development. Regulatory strategies for navigating the path to approval will also be discussed. This course is intended to provide participants from all facets of the pharmaceutical and biotech industry with a broad understanding of regulatory requirements across the product development lifecycle.
Introduction Quality by Design (QbD) for Biopharmaceuticals
Naveen Pathak, PhD, Head, QbD Systems, Shire
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 and other regulators to be presented in regulatory dossier to demonstrate that product will be safe and effective and can be consistently produced over its lifecycle. This 1.5 day course includes case studies and Q&A sessions, and it is intended for scientists and engineers who are new to QbD and/or need an update in their knowledge of the subject. This course will take the students through the journey of using a combination of classroom presentations and case studies such that they will be “ready” to participate in QbD related activities related to a Biotech product.
Intro to Gene Therapy and Viral Vectors
Andrew Steinsapir, PhD, Consultant, Dark Horse Consulting
Introduction to Analytical Method Development and Validation for Therapeutic Proteins
Jichao (Jay) Kang, PhD, RAC, Director, Analytical Development, Amicus Therapeutics
This course is a panoramic review of analytical method development and validation for therapeutic proteins, including antibodies and enzymes. It starts with basic knowledge of work on therapeutic proteins: manufacturing of protein drugs, regulatory affair knowledge and protein chemistry. It then discusses fundamentals and practical aspects of commonly used analytical methods for proteins, 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.
Bioprocess Strategies from Development to BLA
Sheila G. Magil, PhD, Principal Consultant, BioProcess Technology Consultants, Inc.
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 timeline, and explores strategies at each step that can be employed to meet these important goals. Special consideration will be given to the role of new process and analytical technologies, automation and the use of global manufacturing and supply chain networks.
Introduction to Biologics Formulation Development
Donald E. Kerkow, PhD, Director, Biopharmaceutical Development, KBI Biopharma, Inc.
In this training, you will learn strategies to plan and execute preformulation and formulation development studies for biologics. The seminar offers an overview of biophysical and biochemical properties of proteins and protein structure, then continues with an exploration into the theory and application of the relevant analytical and biophysical techniques that support preformulation and formulation development studies. The seminar provides an in-depth discussion of typical formulation development workflows, including statistical analysis and use of DoE, and an examination of real-world case studies.
DOE for Cell and Gene Therapies
Andrew Steinsapir, PhD , Consultant, Dark Horse Consulting
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 and safety. This branch of applied statistics is intimidating, but once explained clearly, surprisingly intuitive and easy to use. This seminar will include specific, practical examples of the application of DOE to optimization cell culture, gene medication and downstream processing unit operations in cell and gene therapy. Attendees will leave with concrete methods and tools enabling them to address their own products’ manufacturing in a sophisticated but practical way.
Protein Aggregation and Formulation Optimization
Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
Molecular interactions are central to protein discovery, development and formulation. This training seminar allows a fundamental, but very practical, understanding of protein interactions, solution behavior, aggregate formation and its application to formulation optimization. Building on a review of central energy concepts, the framework allows a deeper understanding protein structural stability, interactions with small molecules, surfaces, itself, other proteins, and other macromolecules. A deeper insight is afforded into binding, solubility, viscosity, and detection and characterization of protein aggregates.
What is a Training Seminar?
Each Training Seminar offers 1.5 Days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.
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.