Monday, August 13 and Tuesday, August 14
Day One: 1:00 - 5:00 pm | Day Two: 8:00 am - 5:00 pm
TS1A: Introduction to Bioprocessing
CHI's Introduction to Bioprocessing training seminar offers a comprehensive survey of the steps needed to produce today's complex biopharmaceuticals, from early development through commercial. The seminar begins with a brief introduction to biologic drugs and the aspects of protein science that drive the intricate progression of analytical and process steps that follow. We then step through the stages of bioprocessing, beginning with the development of cell lines and ending at scaling up for commercial production. The seminar also explores 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. This 1.5-day class is directed to attendees working in any aspect of industry, including scientific, technical, business, marketing or support functions, who would benefit from a detailed overview of this field.
Sheila G. Magil, PhD, Senior Consultant, BioProcess Technology Consultants, Inc.
Frank J. Riske, PhD, Senior Consultant, BioProcess Technology Consultants, Inc.
TS2A: Regulatory Requirements across the Product Development Lifecycle
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.
Christina Vessely, PhD, Senior Consultant, Analytical and Formulation Development, Biologics Consulting
TS3A: Introduction to Working with CROs, CDMOs, and CMOs
There has been a rise in the securing of external vendors for contract research work (CROs), development & manufacturing (CDMOs), and manufacturing specifically (CMOs) over the past 20 years in the biopharma industry. While initially, these relationships were to provide sources of expertise or scaling that may not have existed at the sponsor organizations, they have quickly become de rigueur to be competitive and successful in the space. These contract organizations provide avenues to access some of the top experts in the various fields of the industry as well as defer and offset risks inherent in the developability, scale-up, and manufacturing for clinical and commercial drug products.
Ben Locwin, PhD, MBA, Contract Operations Strategic Consultant, Valeocon; Former Senior Leadership Team member, Lonza BioPharma & Biogen
TS4A: Potency Bioassay: Practical Approaches to Development and Validation
The potency bioassay is considered a critical release assay for biopharmaceutical products. Why? Because these molecules are complex, and it is physically impossible to ascertain every permutation of a manufactured product and its impact on biological activity. Instead, we develop a potency assay which is a quantitative, comparative assay, to prove the biological activity of each lot is consistent. We have a biologically and statistically complex assay which receives high scrutiny from the regulators. This course will help you through this murky design space, by introducing you to some basic potency assay "tricks of the trade."
Laureen Little, PhD, Principal Consultant, Quality Services and President, BEBPA
Wednesday, August 15 and Thursday, August 16
Day One: 8:00 am - 6:00 pm | Day Two: 8:00 am - 12:15 pm
TS6B: A Line-of-Sight Approach to Continued Process Verification Planning
Planning for Continued Process Verification (CPV) begins during development with the understanding of important product and process attributes to be monitored during the life span of the product. Robust processes and systems need to be implemented to execute the plan. Effective training on the life cycle, as well as statistical and risk-based thinking, is needed to realize the goal. Robust continued process verification (CPV) planning can guide an organization to understand the sources of variation in the product and processes, detect the presence and degree of variation, understand the impact of variation on the process and ultimately on product attributes, and control the variation in a manner commensurate with the risk it represents to the process and product.
Mike Long, PhD, MBB, Senior Director, Consulting Services, Valsource
TS7B: Introduction to Analytical Method Development and Validation for Therapeutic Proteins
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.
Jichao (Jay) Kang, PhD, RAC, Director, Analytical and Formulation Development, Patheon Biologics
TS8B: Introduction to Cell Culture
This 1.5-day Intro to Cell Culture Training Seminar is a lecture-based course intended for the beginner who is thinking about culturing animal cells for the first time or for intermediate cell culturists wanting to know more about how animal cell culture works and how to improve their process. Attendees will learn about most of the critical aspects of cell culture from equipment maintenance and media selection to cell growth and cryopreservation. Participants will have ample time to ask specific questions and get worthwhile answers on such topics as: equipment use and decontamination, cell types, cell verification, maintenance and storage, and strategies for growing animal cells in culture.
Timothy Fawcett, PhD, Scientific Director, BioTechnical Institute of Maryland, Inc. and Founder, BioSciConcepts
TS9B: Bioprocess Strategies from Development to BLA
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.
Sheila G. Magil, PhD, Senior Consultant, BioProcess Technology Consultants, Inc.
TS10B: Data Management in Biotherapeutic Analytical and Process Development
Bioprocess scientists are now being confronted with growing volumes of data from analytical instruments, process monitoring equipment and internal databases - and the organization, correlation and interpretation of this data is now an integral aspect of any analytical or process development program. It has become critical for these groups to develop a strategy for sequence, molecule, sample, assay, and data management, but internal IT functions are often challenged to offer solutions that blend science and informatics in an easy-to-use way. This training seminar will explore the most critical sources of analytical and process data and offer solutions that will augment and unify the datastreams coming from different instruments and permit more meaningful analysis.
Ryan Luce, PhD, Product Manager, LabKey Biologics
Steve Hanson, PhD, Director of Client Education, LabKey Biologics
Thursday, August 16 and Friday, August 17
Day One: 1:30 - 5:00 pm | Day Two: 8:30 am - 3:30 pm
TS11C: Fundamentals of Proteins and Protein Solutions
A simple energy framework is presented that allows a fundamental, but very practical, understanding of protein structure, folding, stability, interactions and solution behavior. The seminar focuses on the practical understanding and application of the energy framework. Building on a review of basic biochemistry and central energy concepts, the framework is used to build up a deeper understanding of how protein folding and structure arise from the properties of its constituent atoms and amino acids. This same energy framework is used to understand protein interactions with small molecules, surfaces, other proteins, and other macromolecules. The importance of cooperativity to biological processes is discussed.
Thomas Laue, PhD, Professor Emeritus, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire
TS12C: Introduction to Downstream Processing
This activity-packed course focuses on the science, technologies and strategies needed to understand and implement an effective downstream process for biological development and production. The course begins with an in-depth look at DSP design and development - from recovery to purification to formulation - before moving onto pertinent issues surrounding HTPD, single-use systems, continuous processing, PAT, CPPs, viral clearance, platform development and process validation. The course concludes with real-world examples from downstream development projects for both traditional and emerging modalities.
Jean-Francois Hamel, Professor, Academic Researcher and Instructor, Chemical Engineering Department, Massachusetts Institute of Technology
TS13C: Designing Flexible Facilities for Bioprocess Development and Manufacturing
This 1.5-day course will introduce attendees to the key facility design considerations that are needed to ensure the creation of a design concept and approach that will yield highly flexible, optimized, and highly utilized manufacturing assets. Key concepts will include development and understanding of a manufacturing enterprise model, the product-process-facility paradigm, "design-to-operate" methodology, appropriateness of GMP design compliance, and the identification and mitigation of risks around a sound QRM approach. The course will implement traditional lecture components, class exercises, and the use of case studies as learning tools.
Jeffery Odum, MSc, CPIP, Global Technology Partner, NNE Pharmaplan; Managing Partner, Strategic Manufacturing Concept Group
TS14C: Introduction to Biologics Formulation Development
CHI's Introduction to Biologics Formulation Development training seminar focuses on strategies to plan and execute preformulation and formulation development studies for biologics. Such projects require co-optimization of multiple physical, chemical, and conformational stability attributes under accelerated timelines to ensure rapid delivery of a stabile product to the clinic. The seminar begins with an overview of biophysical and biochemical properties of proteins and protein structure, setting the stage for the concepts and goals at the core of protein formulation. The course 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 primary focus of the seminar is an in-depth discussion of typical formulation development workflows, including statistical analysis and use of DoE. The formulation development section of the course then concludes with examination of real-world case studies. Attendees of the training seminar should leave with a greater understanding of the biologics formulation field, in general, as well as with specific knowledge and strategies for setting up successful formulation development studies in their own labs.
Donald E. Kerkow, PhD, Director, Biopharmaceutical Development, KBI Biopharma, Inc.
TS15C: 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 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.
Anthony Davies, PhD, Founder & CEO, Dark Horse Consulting
Andrew Steinsapir, Consultant, Dark Horse Consulting
Training Seminar Information
Each CHI 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 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 engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.