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Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, and extensive coverage of the basic science underlying each topic. Experienced Training Seminar instructors offer a mix of formal lectures, interactive discussions and activities to help attendees maximize their learning experiences. These immersive trainings will be of value to scientists from industry and academic research groups who are entering new fields - and to those working in supporting roles that will benefit from an in-depth briefing on a specific aspect of the industry.


MONDAY, AUGUST 21 - TUESDAY, AUGUST 22, 2017

DAY 1 - 1:00 - 5:00 PM | DAY 2 - 8:00 AM - 5:15 PM

TS1A: Introduction to Bioprocessing

This training offers a comprehensive survey of the steps needed to produce today's complex biopharmaceuticals, from early development through commercial. The seminar begins by introducing biologic drugs and the aspects of protein science that drive the progression of analytical and process steps that follows. We then step through the stages of bioprocessing, from cell line development to scaling up for commercial production. The seminar explores emerging process technologies, facility design considerations and the regulatory and quality standards that govern development. The roles of analytical methods at all stages as well as formulation and stability assessments in developing and gaining approval are also examined.

Instructors:

Sheila G. Magil, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.

Frank J. Riske, Ph.D., Senior Consultant, BioProcess Technology Consultants, Inc.

TS2A: Introduction to Extractables and Leachables and Packaging

This 1.5-day training seminar will provide a background on regulatory expectations for materials and components in contact with biologics and the unique applications to biologic delivery systems. Sources of leachables will be realized by understanding components of delivery systems as related to the physical and chemical requirements for various delivery systems. Attendees will be shown how to design studies to understand material chemistry through extractable studies and correlation to potential leachables. These learnings will put into perspective the current regulations and provide a means to develop best practices to manage extractables and leachable issues by applying science and risk based approaches for assessing extractables and acquiring appropriate information to support regulatory submissions.

Instructors:

Diane Paskiet, MS, Senior Director, Global Scientific Affairs, West Pharmaceuticals

Kimberly Ehman, Ph.D., Director, Technical and Regulatory, WuXi AppTec

TS3A: Regulatory Requirements across the Product Development Lifecycle

This course provides 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 provides a broad understanding of regulatory requirements across the product development lifecycle.

Instructor:

Christina Vessely, Ph.D., Senior Consultant, Biologics Consulting

TS4A: Basic Technologies in a Protein Production Lab

This seminar is designed to introduce basic technologies, strategies and considerations in recombinant protein production in E. coli, insect and mammalian cells for multiple research and development applications. The seminar supplies a basic toolbox for management of multiple and diverse projects.

Who should attend: The seminar is designed for researchers, lab managers, graduate students, postdocs, technicians and engineers wishing to expand their knowledge and implement basic and advanced technologies in recombinant protein production in their work.

Instructors:

Tsafi Danieli, Ph.D., Director, BioGivExcubator & Head, Protein Expression Facility, Wolfson Centre for Applied Structural Biology, Alexander Silberman Institute of Life Sciences, The Hebrew University of Jerusalem

Mario Lebendiker, Ph.D., Head, Protein Purification Facility, Wolfson Centre for Applied Structural Biology, Alexander Silberman Institute of Life Sciences, The Hebrew University of Jerusalem


Wednesday, AUGUST 23 -
ThUrSDAY, AUGUST 24, 2017

DAY 1 - 8:00 AM - 6:00 PM
DAY 2 - 8:00 AM - 12:15 PM

TS5B: Pharmaceutical Biotechnology Discovery - From Antibody Engineering to Gene Therapy

This course will introduce the field of Pharmaceutical Biotechnology in a dynamic manner, starting with historical aspects, from the natural products era to the era of recombinant proteins, genes and cells. New therapeutic modalities such as gene therapy, recombinant cell therapy, bispecific antibodies, silencing RNA technologies, and gene editing are being used to treat diseases that were never able to be addressed properly using classical small molecule approaches. The course will delve into current strategies and concepts for treating and even curing diseases that were thought to be untreatable. It will finish by looking toward the future and comparing the landscape of 2025 with that of 2005, demonstrating how technologies have advanced the state of medical sciences like never before.

Instructor:

William Strohl, Founder and Owner of BiSTro Biotech Consulting, LLC

TS6B: 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.

Instructor:

Timothy Fawcett, Ph.D., Scientific Director, BioTechnical Institute of Maryland, Inc. and Founder, BioSciConcepts


ThursDAY, AUGUST 24 -
friDAY, AUGUST 25, 2017

DAY 1 - 1:30 pM - 5:30 PM
DAY 2 - 8:30 AM - 3:30 PM

TS8C: Intro 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, viral clearance, platform development, process validation and bioprocess simulation. The course will be based on real-world examples from downstream development projects for both traditional and emerging modalities. Students will learn through on-site exercises and use of computational tools.

Instructor:

Jean-Francois Hamel, Ph.D., Academic Researcher and Instructor, Chemical Engineering Department, Massachusetts Institute of Technology; Biotech Programs, Northeastern University

TS9C: 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. The course emphasizes practical applications, real-world examples and useful tips.

Instructor:

Jichao (Jay) Kang, Ph.D., RAC, Director, Analytical and Formulation Development, Patheon Biologics

TS10C: Introduction to Biologics Formulation and Delivery

The formulation training seminar focuses on strategies to plan and execute preformulation and formulation development studies for biologics that 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 at the core of protein formulation, then explores the theory and application of the relevant analytical and biophysical techniques that support preformulation and formulation development studies. The course then concludes with examination of real-world case studies.

Instructor:

Donald E. Kerkow, Ph.D., Associate Director, Biopharmaceutical Development, KBI Biopharma, Inc.

TS11C: Designing Flexible Facilities for Bioprocess Development and Manufacturing

Biomanufacturing organizations today are looking for best practice approaches to create flexible manufacturing assets to support overall business needs. With expanding product pipelines and the introduction of new technology platforms, creating an asset that will not only have a long lifecycle expectancy but one that will also be flexible to meet development and commercial launch needs is a paramount business goal.

This two-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.

Instructor:

Jeffery Odum, MSc, CPIP, Global Technology Partner, NNE Pharmaplan; Managing Partner, Strategic Manufacturing Concept Group



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.



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