TRAINING SEMINARS *
Introduction to Biologics Formulation and Delivery
The course will focus on strategies to plan and execute preformulation and formulation development studies for biologics, which require co-optimization of multiple physical, chemical and conformational stability attributes while operating under accelerated timelines to deliver the drug to the clinic. The course begins with an overview of biophysical and biochemical properties of proteins. A typical development workflow (including statistical analysis and DOE elements) will be outlined to demonstrate the core elements employed during protein formulation. The course concludes with real-world examples from formulation development projects for both liquid and lyophilized products.
- Basics of protein biochemistry, with focus on folding mechanism, stability and structural hierarchy
- Degradation pathways relevant to biologics shelf life
- Biophysical and analytical characterization tools
- Typical workflow for biologics formulation development projects
- Introduction to common delivery devices
View sample slides from this training seminar presentation
Pooja Arora, Ph.D., Senior Manufacturing Technical Specialist, Genentech-A member of the Roche Group
Pooja Arora is a Senior Manufacturing Technical Specialist in the Global Biologics Manufacturing Science and Technology-Drug Product at Genentech. Pooja has more than twelve years of experience in protein biophysical and analytical characterization. Her responsibilities at Genentech include technical transfer of commercial Drug Product manufacturing process to both internal and external manufacturing sites. Pooja has extensive experience in development of robust drug product and manufacturing process for protein therapeutics, including identification of optimum formulation conditions that impart stability to achieve the desired shelf-life, use time stability and selection of primary packaging components. At KBI Biopharma, Pooja was the technical lead for projects that focused on preformulation/formulation development and stability studies. Pooja earned her Ph.D. in Chemistry from Duke University.
Timothy Kelly, Ph.D., Vice President, Biopharmaceutical Development, KBI Biopharma, Inc.
Tim has over 20 years of experience in protein and nucleic acid characterization. In his role at KBI Biopharma, Tim is responsible for analytical development, formulation development, and quality control. Prior to joining KBI Biopharma, Tim held the position of Director of Quality Control for Diosynth Biotechnology, where we was responsible for method validation, in-process control, release, and stability of clinical and commercial biopharmaceutical products. Tim’s experience also includes the analytical development, formulation development, characterization and/or production of more than 200 clinical and commercial protein therapeutics, including monoclonal antibodies, enzymes, cytokines, fusion proteins, PEGylated proteins, protein vaccines, and peptides. Tim has led the successful formulation development of over 95 clinical and commercial biopharmaceutical products, including liquid and lyophilized dosage forms for intravenous and subcutaneous administration, at protein concentrations ranging from 10µg/mL to 200mg/mL. Tim earned his Ph.D. in Molecular Genetics & Biochemistry from Georgia State University.
Lyophilization Principles and Practices for Bulk Substances and Drug Products
The course is designed to review the basic principles as an introduction as well as discuss advanced concepts in the science and technology of freeze drying. An explanation of basic theories is used to explain contemporary approaches to product development, process engineering, technology transfer and routine manufacturing. Application of the principles will encompass finished drug product as well as bulk materials. The course is intended for professionals in development, technical services, engineering, manufacturing and quality control.
- Introduction and example freeze drying cycle
- Steps of the process: freezing, primary and secondary drying
- Principles of vacuum technology
- Low temperature thermal analysis
Edward H. Trappler, Founder and President, Lyophilization Technology, Inc.
Ed Trappler is president and founder of Lyophilization Technology, Inc. a contract research and technical services firm dedicated to freeze drying. He has over 30 years experience in lyophilization that ranges from product development to equipment application engineering. He received his Bachelor of Science degree in chemistry at The College of New Jersey. His experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing and parenteral production.
He began his career in 1976 as a development technician in Product Development at Elkin-Sinn Inc. in Cherry Hill, New Jersey. He was later promoted to Production Supervisor in charge of start-up for prefilled syringe and lyophilization operations. He then joined McNeil Pharmaceutical, one of the Johnson & Johnson companies, as a Technical Associate in the Toxicology and Clinical Material preparation group. In 1984 he joined the Hull Corporation as a Systems Application Engineer until founding the company in 1992.
Ed has contributed chapters to five books, authored and presented numerous papers and courses in freeze drying in the United States, Europe, Japan and China. He is an active member of the PDA, serving on a number of committees, including as chairperson of the Lyophilization Validation Task Force. The PDA awarded Ed the Gordon Personeous award for his long term contributions to the PDA and the James Agalloco award for his contribution to education. He is also a member of the American Association of Pharmaceutical Scientists, American Institute of Chemical Engineering, and International Society of Pharmaceutical Engineers.
Scaffold Engineering for Target Binding and Extended Serum Half-Life
Following the approval of antibody Fab fragments as therapeutics, rapid progress towards even smaller “scaffolds” has been made. This workshop covers the key aspects of engineering novel scaffolds for binding to diverse targets. What can be transferred from our knowledge of antibodies, and what new aspects need to be considered or re-thought for small scaffolds? Novel approaches to extending the short serum half-life of small scaffolds are also covered.
- Mimicking antibody-like binding loops
- Differences for single-domain binders vs. scFv, Abs
- Designing libraries
- Why antibodies have a long serum half-life
- Molecular engineering to extend half-life of scaffolds
View sample slides from this training seminar presentation
David Bramhill, Ph.D., Founder, Bramhill Biological Consulting, LLC
Dr. Bramhill has over 20 years experience in biologics, both in large biopharma and startup biotech companies. He has experience in isolating and improving antibodies using phage display and is an inventor on library design for small scaffolds. He also has experience in diverse expression systems for producing antibodies, antibody fragments and different scaffolds. He has taught numerous technical courses for over 10 years at international conferences.
Introduction to Synthetic Biology for Protein Therapeutics - Detailed Agenda
This course provides an introduction and overview for targeting DNA and in silico synthetic biology assembly and expression optimization methods to engineer synthetic and natural genes, genetic pathways and genomes for recombinant therapeutic protein production.
- Computer-aided design (in silico methods)
- Fabrication and optimization for gene(s) of interest
- Genome editing/manipulation (zinc fingers, TAL effectors, CRISPR)
- Engineering biological outcomes (case studies)
Kevin Clancy, Ph.D., Senior Staff Scientist, Bioinformatics & Synthetic Biology, Life Technologies
James Kaysen, Ph.D., Staff Scientist, Life Technologies
Camille Delebecque, Ph.D., Founder and CEO, SynBio Consulting
Camille is the Founder and CEO of SynBio Consulting (www.synbioconsulting.com). SynBio Consulting works with leading organizations across the private, public and social sectors – organizations eager to change and get an edge in Synthetic Biology and the ever-changing landscape of Life Sciences. From providing R&D expertise to assisting with science communication, strategic and business decisions, SynBio Consulting is passionate about taking on immense and world-changing challenges that matter to its clients. Prior to founding SynBio Consulting, Camille worked at Puretech Ventures on the Enlight Bioscience startup portfolio. He was a consultant for the Harvard Office of Technology Development, a Director of the Harvard Biotech Club and worked for the Life Science division of UNESCO. Camille is trained as a bioengineer and earned his Ph.D. in Synthetic Biology with the highest distinctions. His thesis work was published in leading scientific journals and made the cover of Science.
Farzad Haerizadeh, Ph.D., Synthetic Biology Lead R&D Specialist, Life Technologies
Synthetic Biology Lead R&D at Life Technologies in Carlsbad, CA, Dr. Farzad Haerizadeh, along with his team, are developing synthetic biology parts, devices and chassis for a variety of organisms with industrial and medical values including algae, yeast, bacteria and mammalian cell lines. He received his Ph.D. degree from The University of Melbourne, Australia, and has two postdoctoral training stints in the same university, also at Stanford University, CA, USA. Farzad joined Life Technologies after a stint at Codexis Inc., in Redwood City, CA, where he worked on various projects on metabolic and pathway engineering for production of biofuels and value-added chemicals. He has nearly 10 years of experience in systems biology, industrial microbiology and metabolic engineering, and he is expert in physiology and manipulation of variety of organisms. His team is currently working on developing genome editing tools and technologies for mammalian cell line engineering, including TALEs and CRISPR.
Bolyn Hubby, Ph.D, Head, Vaccine R&D, Synthetic Genomics Vaccines, Inc.
Dr. Bolyn Hubby is the Senior Director, Head of Vaccine R&D at SGVI. Bolyn has spent more than 10 years in the biotechnology industry, leading product development efforts from early concept stages into clinical evaluation. Prior to joining SGVI, Bolyn was at Liquidia Technologies, a nanotechnology company, where she helped build and lead the company’s life science business and vaccine focus. As Executive Director of Vaccines, she helped advance Liquidia’s platform technology into the clinic and built a portfolio of programs that attracted a major licensing deal with a leading pharmaceutical partner. Prior to Liquidia, Bolyn was the Head of Discovery Immunology at AlphaVax, Inc., a clinical stage company that is commercializing a unique RNA replicon vector to develop vaccines for infectious diseases, biodefense and cancer. While at AlphaVax, she designed and developed replicon vaccine candidates for infectious disease and cancer immunotherapy targets and many of these were advanced into clinical evaluation. In addition, her team was responsible for improving the immunogenicity of the platform. Bolyn received her Ph.D. degree from the University of Georgia, Center for Tropical and Emerging Diseases and Department of Cellular Biology.
Course Information: Each course is 1.5 days, and lunch is provided on the first full day. Course attendees will each receive a handbook with instructor presentation materials.
* Separate registration is required.