Training Seminars - 2023 Archive

2023 Archived Content

Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, along with extensive coverage of the academic theory and background. Each Training Seminar offers a mix of formal lecture and interactive discussions and activities to maximize the learning experience. These Training Seminars are led by experienced instructors who will focus on content applicable to your current research and provide important guidance to those new to their fields.

2023 topics will include bioprocessing, CMC, viral vectors and gene therapy, potency assays and comparability, and integrating AI and data science in the product life cycle.

Training Seminars Will Be Offered In Person Only

Monday, August 14, 2023 10:00 am - 3:30 pm | Tuesday, August 15, 2023 8:00 am - 1:00 pm

TS1: Introduction to Bioprocessing

Detailed Agenda

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 the industry, including scientific, technical, business, marketing, or support functions, who would benefit from a detailed overview of this field.

Sheila Magil, PhD, Independent Consultant

Frank Riske, PhD, Managing Director, BioProcess Technology Group, BDO USA, LLP

TOPICS TO BE DISCUSSED:

An Introduction to Biopharmaceuticals and Bioprocessing

Analytical Methods for the Characterization and Release of Biotherapeutics

Structure-function
Bioassay
Higher-order structure
Phase-appropriate methods

Quality Systems

Overview
Quality by Design (QbD)
Phase-appropriate quality systems

The Science and Technologies of Bioprocess Unit Operations

Cell Line and Upstream Development

Expression system selection and development
Cell banking: Master and working cell bank generation and testing
Cell culture and fermentation development
Continuous feed/perfusion/fed-batch
Single-use

Recovery and Downstream Development

Affinity capture
Platform processes
Purification development strategies
Polishing and final processing
Viral clearance validation

Drug Product Development

Liquid, lyophilized, and other forms
Formulation development
Device and packaging considerations
Combination products

Scaling-Up Drug Substance

Considerations in scaling-up
Engineering and first cGMP runs
Facility considerations
Tech transfer

Comparability during Scale-Up and after Process Changes

Ready for Late-Stage Development

Process qualification
Facility concerns
Equipment qualification

Ready for Commercial

What is needed?
Supply chain considerations
BLAs/NDAs

INSTRUCTOR BIOGRAPHIES:

Sheila Magil, PhD, Independent Consultant

Sheila Magil has over 40 years of experience in quality and analytical method development for biologics, peptides and small molecules. Her expertise includes quality assurance, protein and peptide biochemistry and analytical development. She was formerly Senior Manager of Analytical Development and Quality Control at Biomeasure, Inc., and previously held positions at Waratah Pharma, Alkermes, Bion and HHMI at Massachusetts General Hospital. Dr. Magil has implemented quality systems and has managed external analytical and QC activities for multiple biopharmaceutical products. Dr. Magil holds a PhD in Biochemistry from the University of Minnesota.

Frank Riske, PhD, Managing Director, BioProcess Technology Group, BDO USA, LLP

Frank J. Riske, PhD, has over 30 years of experience in the biopharmaceutical industry and has been involved in the development, or improvement, of eight commercial protein products. Prior to joining BioProcess Technology Group, Dr. Riske was a Senior Director in the Late Phase Process Development Group at Genzyme, a Sanofi company. At Genzyme, Dr. Riske was responsible for the development of late-stage downstream processes for recombinant enzymes, monoclonal antibodies, adenovirus (gene therapy), and the identification and exploration of new technologies, including continuous processing, to streamline and improve purification. Prior to joining Genzyme, Dr. Riske managed the development, implementation, and manufacture of a peptide bound within a novel sustained-release vehicle and the development of a next-generation process to purify IVIG from plasma (both at Epic Therapeutics). Before Epic, Dr. Riske held positions at Repligen and Hoffmann-LaRoche during which he developed and improved downstream processes for proteins produced in mammalian cell culture, E. coli, and Pichia systems. Dr. Riske was also responsible for the manufacture of mAb fragments at Repligen. Dr. Riske has published over twenty peer-reviewed papers and patents and is active in the scientific community as both a mentor to young scientists and as a conference speaker and organizer. He is also on the Advisory Board for the Biotechnology Journal. Dr. Riske received his BS in Biology from Fairfield University, PhD in Biochemistry and Microbiology from Rutgers University, and completed a post-doctoral position at Hoffmann-LaRoche.

TS2: Integrating AI and Data Science in the Product Life Cycle

Detailed Agenda

Regulatory expectations for statistically underpinned Process Validation (PV) have found their way into current guidelines leading to demonstrating Established Conditions (ECs) in ICH Q12. However, successful and accelerated biopharmaceutical process validation (Stage 1-3) remains unresolved in industrial practice. This is due to the necessity of using scale-down models, the cost-intensive setup of experiments, and the complexity due to the interactivity of a multitude of unit operations. The commonly accepted hypothesis is that sound data science and digital twin approaches will be a success factor in this endeavor.

Christoph Herwig, PhD, former Professor, Bioprocess Engineering, TU Wien; CPO, Fermify GmbH; Senior Scientific Advisor, Körber Pharma Austria GmbH

Sherwin Jayashinghe, Technical Sales Engineer, Koerber Pharma Software

This training seminar will focus on:

Hands-on learning of basic principles and best practices performing data analytics and data management for integrated bioprocesses. Bring your own laptop. You will perform exercises on bioprocess data management and analytics using the web-based educational software tool PAS-X Savvy.
Methods and best practices embedded in workflows based on data science and digital twins, using case studies and hands-on exercises. Designed for the biopharmaceutical and industrial biotech industry.
Contemporary and novel approaches to accelerate process development, efficiently gaining CMC process understanding for meeting Stage 1 Validation expectations.

Learning Objectives

Understand regulatory perspectives on challenges and concerns in bioprocess validation.
Gain insights into new tools and workflows to target critical components towards a successful bioprocess stage 1 validation and technology transfer.
Gain hands on experience in solving challenges for bioprocess validation, such as scale down model qualification, experimental design & evaluation, as well as setting up a control strategy.
Understand challenges in process validation life cycle. Explore challenges and emerging solutions in process validation for current and next generation bioproducts.
See the potential of digital twins for accelerating the product life cycle and increase process robustness.
Participate in demonstrated application through review of multiple case studies.

INSTRUCTOR BIOGRAPHIES:

Christoph Herwig, PhD, former Professor, Bioprocess Engineering, TU Wien; CPO, Fermify GmbH; Senior Scientific Advisor, Körber Pharma Austria GmbH

Christoph Herwig, bioprocess engineer from RWTH Aachen and obtained a PhD in bioprocess identification at EPFL, Switzerland. From 2008 to 2023, he was full professor for biochemical engineering at the Vienna University of Technology. The research area focused on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. During his employments in various industries, such as with Lonza, he was deeply involved in the design and commissioning of large chemical and biopharmaceutical facilities. In 2013 he founded the company Exputec, which is now part of Körber Pharma, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently also acts as senior scientific advisor for Körber. In 2021 he cofounded Fermify and acts as CPO, focusing on providing a fully digitalized production platform for vegan cheese.

Sherwin Jayashinghe, Technical Sales Engineer, Koerber Pharma Software

Sherwin Jayasinghe is a Technical Sales Engineer for Koerber Pharma Software. In this role, Sherwin has presented technical demonstrations of PAS-X Savvy to potential clients that are interested in the capabilities of the software. He is a graduate of Rutgers University-New Brunswick with a Master's in Information Science with a concentration in Data Science.

TS3: Introduction to Viral Vectors and Gene Therapy

Detailed Agenda

Targeting disease at its origin, gene therapies offer the promise of a one-time treatment and have transformed how we treat some diseases. These medicines are complex biologics requiring advanced manufacturing methods and highly skilled operators. This training session provide an expansive introduction to gene therapy, the manufacture of these complex biologics, the facilities, equipment and personnel needed to produce them; and the analytical and quality aspects surrounding them.

Scott Cross, Senior Principal, Dark Horse Consulting Group

Jacob Staudhammer, Principal, Dark Horse Consulting Group

Catherine Colandro, PhD, Senior Consultant, Dark Horse Consulting

The session will cover but not be limited to:

Viral and non-viral vectors
Gene Editing
Manufacturing methods and processes
Facility design
Equipment
Analytics
Quality

INSTRUCTOR BIOGRAPHIES:

Scott Cross, Senior Principal, Dark Horse Consulting Group

Scott has 24+ years' experience in the G&CT field and working in GMP environments. He has been responsible for cleanroom design and build-out and commissioning of vector facilities, as well as the oversight of cell therapy, fill finish, and manufacturing support departments. Scott started his career at Merck and Co. working on the development of an adenovirus-based HIV vaccine, before moving on to manage GMP production and testing at the Indiana University (IU) Vector Production Facility and the National Gene Vector Laboratories (NGVL). He then went on to manage GMP viral vector production at Cincinnati Children's Hospital before becoming the Director of Cell Therapy, Fill Finish, and Support Operations at Florida Biologix/Brammer Bio. Prior to joining Dark Horse, Scott was the Vice President of Vector Operations at Orchard Therapeutics.

Jacob Staudhammer, Principal, Dark Horse Consulting Group

Jacob joined Dark Horse Consulting in 2021, bringing over 5 years of experience in the Biotechnology industry, primarily focused on process development and characterization of gene therapy viral vectors from early pre-clinical development to design of PPQ campaigns.

Catherine Colandro, PhD, Senior Consultant, Dark Horse Consulting

Process engineer with experience in CGT process optimization and technology development and deployment. Catherine joined Dark Horse Consulting in 2020, bringing 4 years of prior experience in process development of cell and gene-modified cell therapy products, with a past focus of optimizing late-stage cell therapy processes for commercial readiness and launch. Catherine’s career started at Biogen in research triangle park (RTP), where she was involved in the transfer and monitoring of new therapies from clinical to commercial stages. At Biogen she developed technical knowledge of upstream laboratory operations for several monoclonal antibody therapies. She supported molecules at the RTP site by conducting process monitoring and laboratory experiments to assess process robustness and optimization. Catherine then joined Juno Therapeutics in 2016 in Seattle as a process engineer. It was there she was able to make process changes to the clinical CAR-T cell manufacturing processes. Her main focus was to optimize the cell therapy processes in order to increase operational efficiency to ensure successful delivery of the life-saving therapies to patients. She designed and executed multi-donor studies to support the processes changes and aided cGMP implementation and regulatory filings. One of her areas of expertise is on T cell media and buffer preparations and the automation and scale up of these activities. She has also assessed and implemented customized single use solutions for several unit operations of the cell therapy processes. During her time at Juno she led root cause analyses, risk assessments, data analyses and authoring of technical reports to support process changes and investigations.

Wednesday, August 16, 2023 8:00 am - 3:00 pm | Thursday, August 17, 2023 8:00 am - 12:00 pm

TS4: Potency Assays and Comparability for Cell and Gene Therapies

Detailed Agenda

The evaluation of potency plays a key role in defining the quality of cellular and gene therapy products. CHI's Training Seminar, Potency Assays and Comparability for Cell and Gene Therapy, provides an insight into the expectations and challenges in development of potency assays specific for cell and gene therapies; several real-life experiences from the industry are presented as illustrations, including the impact of comparability assessment following process change.

Christopher Bravery, PhD, Consulting Regulatory Scientist, Advanced Biologicals Ltd.

INSTRUCTOR BIOGRAPHIES:

Christopher Bravery, PhD, Consulting Regulatory Scientist, Advanced Biologicals Ltd.

Christopher founded Consulting on Advanced Biologicals Ltd at the end of 2009 in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd, A Novartis Pharma AG Co. and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

TS5: Introduction to CMC for Biotech, Cell & Gene Therapy Products

Detailed Agenda

The chemistry manufacturing and controls (CMC) of biologics is a multidiscipline technical operation of bioprocess, analytics, dosage formulation and cGMP manufacturing/testing for DS/DP release and stability to treat human diseases. This interactive training course will provide a comprehensive CMC overview of therapeutic biological products. It introduces a variety of therapeutic modalities including recombinant proteins, monoclonal antibodies (Mab), and cell and gene therapy (CGT) in the context of IMPD and IND regulatory filing. Attendees will learn scientific, technical, and operational aspects of overall biologics CMC activities as well as quality compliance and regulatory requirement. The instructor will present common pitfalls and share the best industry practices. Numerous real-world regulatory queries/comments from health authorities worldwide will be exemplified as case studies during the training course.

Kevin Zen, PhD, Senior Director, IGM Biosciences

TOPICS TO BE COVERED:

1. Diverse modality of therapeutic biological products

2. Biologics CMC activities for regulatory filing (IMPD/IND)

3. Quality by design (QbD) concept, quality target product profile (QTPP), and critical quality attributes (CQA)

4. Cell line development, process development, and manufacture of biologics, CGT DS and DP

5. Current analytical technologies to characterize product variants/impurities, process impurities (e.g., HCP), and contaminants

6. Formulation development and compatibility with container closures and injection devices

7. Reference material characterization/qualification and justification of specifications for DS/DP release and ICH stability for product expiry

8. Process validation, analytical validation, and control strategy of cGMP manufacturing

9. Manufacturing process changes during product development lifecycle: CMC comparability exercise

WHO SHOULD ATTEND: The course is beneficial to individuals involved in biologics drug research/development, bioprocess development, analytical development, formulation development, quality control, quality assurance, regulatory affairs, project management, or related functional areas.

INSTRUCTOR BIOGRAPHIES:

Kevin Zen, PhD, Senior Director, IGM Biosciences

Kevin has over 20 years of broad experience in Biologics CMC, and Strategic and Technical Operations. Prior to joining IGM Biosciences, he held various positions in biologics CMC disciplines at Allergan, AnaptysBio, AstraZeneca, Becton Dickinson, and Catalent Biopharma Solutions. In addition to developing therapeutic biological products in-house, Kevin also had extensive experience working with external contract manufacturing organizations (CMO) and contract research organizations (CRO), including production cell line development, bioprocess development, DS/DP cGMP manufacturing, process characterization, process performance qualification (PPQ), formulation development by DoE, analytical procedure development and method validation, reference standard qualification, extended characterization, and CMC analytical comparability.