Panel discussions addressing modern workflow strategies
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Stay current with the latest trends in workflow strategies. In these events you will hear from peers and experts who have tackled the challenges you face as you develop your new therapy and bring it to the clinic and beyond. Panelists discuss how to address some common pain points in bioprocessing and cell and gene therapies.
Who should attend?
The fastest way to produce material for your next clinical trial might be to outsource to a qualified service provider. Hear about some things to consider in making critical decisions on whether to outsource some or all your clinical activities. Topics:
- Trends in the CDMO space
- Decisions to outsource—what, when, and why
- Specific CDMO capabilities to look out for
- Location, quality and compliance, and tech transfer
Annu Jain (Moderator) has 19 years of biopharma industry experience in biologics downstream process development. She previously worked at Sanofi, Genzyme and Human Genome Sciences, where she led research outsourcing activities and managed teams of protein purification experts. She has hands-on experience developing bioprocess flows for hundreds of lead discovery drug candidates. At Cytiva, she manages a talented team of scientists that help customers develop robust downstream processes and conduct lifetimes studies.
Joseph Makowiecki is FlexFactory Director of Business Development at Cytiva. Joe has been in the Bioprocess industry for 24 years and has held management, senior management, and director positions within Process Development, Pilot Plant, cGMP Manufacturing, and Enterprise Solutions organizations. His expertise and experience also include the design and implementation of single-use and hybrid manufacturing facilities as well as educating and training of operators and customers on downstream processing and single-use technologies.
Yasser Kehail is Sr Upstream Applications Leader, Cytiva. Yasser has over 10 years’ experience in cell culture manufacturing, development and optimization. He currently supports customers working on different therapeutic modalities. Specifically offering consulting on upstream scale-up strategies and transitioning processes from traditional to single use. Yasser began his career at Biogen in cell culture manufacturing, and then moved to Upstream PD at Amgen, before joining Cytiva.
Translating a long history of biopharma knowledge and expertise to cell therapies requires that we standardize workflows and equipment. Learn ways to address process development (PD) pain points in your upstream and downstream workflows.
Topics:
- Upstream PD for stem cell manufacturing
- Cell expansion and scale-up
- Differentiation of pluripotent stem cells
- Downstream PD for viral vector manufacturing
- Nucleic acid digestion
- Clarification and ultrafiltration/diafiltration (UF/DF)
- Sterile filtration
- 25 L case study
Gary Pigeau (Moderator) joined Cytiva in 2016 and is Director of the Centre for Advanced Therapeutic Cell Technologies (CATCT) at CCRM in Toronto, Ontario. He received his Ph.D. in Biotechnology from Brock University and completed a postdoctoral fellowship at the University of Alberta, with a visiting scientist appointment at the University of Oxford. One of Gary’s first projects at CATCT was design oversight of the custom media development infrastructure. The CATCT collaboration has a focus on biology support for new product introductions, internal technology development projects, and contract process development services in cell and gene therapy.
Stephie Leung is a Development Associate at Cytiva. Stephie is part of the Cytiva Fast Trak Centre for Advanced Therapeutic Cell Technologies (CATCT), in collaboration with the Centre for Commercialization of Regenerative Medicine (CCRM) in Toronto since January 2017. She works primarily on lentiviral vector downstream processing to improve infectious titer recoveries at each stage of unit operations. She also helped to expand the analytics development capabilities for assays used to define cell and gene therapy products.
Janet Rothberg is a Development Manager with the Center for Commercialization of Regenerative Medicine (CCRM) in Toronto and has been with the group since 2016. She received her PhD from the University of Ottawa in Cellular and Molecular Medicine. At CCRM, her work has focused on early scale-up of iPS-derived cell therapies. Her projects have included the translation of cardiac and hepatocyte differentiation protocols from 2D to suspension culture.
There are many parallels between developing cell lines and formulating media. Hear about development strategies for both that will help you achieve optimal outcomes.
Topics:
- Custom media development for cell and gene therapy
- Top-down vs. bottom-up approach
- Mass spectrometry and multivariate statistical analysis
- DoE formulations screening
- Animal component-free case study
- Cell line development for viral vector production
- Cell line screening
- Suspension adaptation
- Transfer vector integration techniques
- Viral titering
Philip G. Vanek, Ph.D. (Moderator), Partner at Gamma Biosciences. Phil is a passionate advocate for regenerative medicine and the role it will play in treating diseases as global healthcare systems transition to precision health models. An entrepreneurial and strategic international business leader, Phil has led marketing, business development, and innovation in start-up and established biotechnology companies. Phil received his PhD in Biochemistry and Molecular Biology at Georgetown University Medical Center. Phil held leadership positions at Life Technologies, Atto Bioscience, BD Biosciences, Lonza Bioscience, and Cytiva prior to his current role as partner at Gamma Biosciences. His business and academic experiences give him a unique perspective of the global opportunities and challenges of the biotechnology industry.
Gary M. Pigeau, Ph.D. is Director, Centre for Advanced Therapeutic Cell Technologies. Gary joined Cytiva in 2016 and is Director of the Centre for Advanced Therapeutic Cell Technologies (CATCT) at CCRM in Toronto, Ontario. He received his Ph.D. in Biotechnology from Brock University and completed a postdoctoral fellowship at the University of Alberta, with a visiting scientist appointment at the University of Oxford. One of Gary’s first projects at CATCT was design oversight of the custom media development infrastructure. The CATCT collaboration has a focus on biology support for New Product Introductions, internal technology development projects and contract process development services in cell and gene therapy.
Steven Loo-Yong-Kee is a senior development associate at CCRM focusing on improving manufacturing and accelerating commercialization of viral vectors and immunotherapies. His experience includes developing and optimizing a semi-automated closed CAR-T manufacturing process utilizing commercially available cGMP media, reagents and equipment, as well as evaluating serum-free suspension cell lines and transient transfection methods for scalable for LV and AAV production.
Getting your process scaled and regulatory ready is essential. Dive into process design and validation considerations for QA and QC in a cGMP environment.
Topics:
- Process design
- Understanding robust design
- Process development
- Scale-up and process closure and automation
- QC and release testing
- Process validation
- cGMP considerations ‒ getting ready for compliance
- Testing methods and analytical assays
- Regulatory readiness
- Customer case study – best practices
Aaron Dulgar-Tulloch (Moderator) is Global Head of Research and Development, Cell and Gene Therapy at Cytiva. He is a technical business executive with experience building and managing global teams and businesses. Deep technical expertise in cell and gene therapy with demonstrated success in new product development. Experience building and operating process development services and product development businesses.
Candace Rhodes is Development Manager Cell & Gene Therapy at Cytiva. Candace has 10 yrs industry experience in biologics and medical device product development and production experience with a focus on cell therapy, tissue engineering, and regenerative medicine. Received her Ph.D. in Bioengineering from the University of Pittsburgh with research at the McGowan Institute for Regenerative Medicine and B.S. in Biomedical Engineering from University of Rochester. Within Cytiva, she leads the Cell & Gene Therapy Marlborough, MA FastTrak Process Development and Biology R&D team and the Eysins, Switzerland Biology R&D team.
Steven Keizer is Director Of Quality at CCRM. "My professional experience up to now has focused on the technical side of science, leading to my personal realization that I should focus on leading high performance teams. I find that throughout my experiences, technical skills are teachable and easy to learn, but the human side of dealing with people, namely customers(both internal and external), regulators and leading change within organizations is my next focus area.During my career in the healthcare industry, either within the product offering (pharmaceuticals, devices, health products) or some other service provider, I have realized the impact this sector can have in the quality of peoples lives is tremendous."
Time to experiment, time to clinic, and time to market are critical, yet the data must be comprehensive. Learn about advanced PD technologies that reduce timelines and improve data outcomes.
Topics:
- In-silico process development and data-driven decisions
- Management of process variability through deeper process understanding
- Use of high-throughput methodologies
Peter Hagwall is Product strategy manager for process development tools at Cytiva. In his role, he drives development activities for smarter and faster process development and manages high throughput process development formats. Previously, Peter was responsible for multimodal and HIC bioprocess resins and was part of developing resins such as Capto™ adhere ImpRes and Capto Core 700. In his past, Peter investigated NIR and multivariate modeling to control and optimize fermentation and cell culture feed strategies and his interest in purification sparked when he studied how cellulases interact with cellulose surfaces in his PhD studies.
Thiemo Huuk, CEO, GoSilico. Thiemo is co-founder and Chief Executive Officer at GoSilico. Thiemo studied molecular biotechnology and in 2016 he received a PhD in bioengineering from the Karlsruhe Institute of Technology (Germany). During his PhD he collaborated with Roche Diagnostics on establishing tools for model-based process development of chromatography. The learnings from this work were later incorporated into GoSilico’s ChromX technology.
Is your downstream process development workflow relying on experimental data alone, or are you leveraging mechanistic modeling? Gain a better understanding of effective modeling implementation to develop robust lab scale processes, enabling smooth scaling into cGMP manufacturing.
Topics:
- Why and how to apply mechanistic modeling to chromatography
- Case studies:
- Virus like particles/antibodies
- Process characterization and better understanding of design space
- Efficient process scale up/down
Thiemo Huuk is co-founder and Chief Executive Officer at GoSilico. Thiemo studied molecular biotechnology and in 2016 he received a PhD in bioengineering from the Karlsruhe Institute of Technology (Germany). During his PhD he collaborated with Roche Diagnostics on establishing tools for model-based process development of chromatography. The learnings from this work were later incorporated into GoSilico’s ChromX technology.
Tobias Hahn, Ph.D., is co-founder and Chief Executive Officer of GoSilico. He received his undergraduate education in computational mathematics and technical physics in Karlsruhe and Stockholm, earning his PhD in chemical engineering from Karlsruhe Institute of Technology. During his PhD, he utilized is background in mathematics and software development to create the chromatography simulation software ChromX.
Advanced PD technologies can reduce timelines and improve data outcomes. Take a deep dive into theory and software practice, including how to select appropriate models.
Topics:
- ChromX overview - GUI, nomenclature, inputs and variables
- Live simulation with data import and optimization exercises
- Attendees will receive free ChromX trial license and support, after the event
Thiemo Huuk is co-founder and Chief Executive Officer at GoSilico. Thiemo studied molecular biotechnology and in 2016 he received a PhD in bioengineering from the Karlsruhe Institute of Technology (Germany). During his PhD he collaborated with Roche Diagnostics on establishing tools for model-based process development of chromatography. The learnings from this work were later incorporated into GoSilico’s ChromX technology.
Nora Geng, Project Engineer, GoSilico, holds a master’s degree in bioengineering from Karlsruhe Institute of Technology. Since 2018, she works with GoSilico, being responsible for software trainings and GoSilico’s modeling services. Nora is an expert in model-based process development, and has an outstanding track record in modeling an extensive range of chromatography operations for a variety of biologics.
Tobias Hahn, Ph.D., is co-founder and Chief Executive Officer of GoSilico. He received his undergraduate education in computational mathematics and technical physics in Karlsruhe and Stockholm, earning his PhD in chemical engineering from Karlsruhe Institute of Technology. During his PhD, he utilized is background in mathematics and software development to create the chromatography simulation software ChromX.
Fibro PrismA is a new protein A fiber chromatography format developed to complement traditional resin-based chromatography. The protein A fiber matrix has an open pore structure where mass transfer is governed by convective flow. This structure allows high mAb binding capacities at very short residence times, which reduces cycle times to minutes instead of the hours needed for resin-based chromatography. These short cycle times enable high-throughput purification of mAbs and opportunities for significant time savings in process development. At a larger scale, the protein A fiber operated in a rapid cycling manner allows full utilization of the protein A lifetime during one batch as well as cost-effective single-use chromatography. In this presentation we will show examples of how Fibro PrismA technology can help to optimize wash and elution buffers in downstream process development and reduce development times. We will also show how this scalable technology enhances productivity at process scale.
Oliver’s academic expertise is in the field of novel purification approaches in bioprocessing having completed an Engineering doctorate at University College London in the department of Biochemical Engineering. In 2013 he founded Puridify, which was sold to GE Healthcare, now Cytiva, in 2017 to continue the development and commercialisation of novel bioprocessing platform technologies allowing for the cost effective manufacture of a wide range of existing and new biomolecule products including viral vectors. As a Director of Puridify and Business Leader at Cytiva, Oliver continues to support the innovation, strategic development and commercialisation of technology, interacting with biotherapeutic manufacturers globally through this process. He represents UCL as an honorary lecturer and regards industry-academia links as critical for the development of our industry. He is also an elected board member of BioIndustry Association (BIA), a trade association promoting the ecosystem for innovative life sciences in the UK.
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
8 April 10:00AM EDT | 16:00 CEST Register
There is no misrepresentation in the potential of connected and continuous manufacturing. So why isn’t everyone adopting these benefit-packed processes? This presentation will share GE’s strategy for the building confidence in technology & process knowledge. It will also address the regulatory expectations and business case examples for connected & continuous processes in biomanufacturing’s future.
Avril Vermunt, Connected Biomanufacturing Program Manager
As a Connected Biomanufacturing Program leader, Avril brings strong experience from large scale bioprocessing and a profound understanding of process intensification. Avril joined the GE Healthcare’s Life Sciences business in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering. She is currently pursuing an Executive MBA at the University of Colorado.
29 April 10:00AM EDT | 16:00 CEST Register
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, Cytiva introduced Chronicle™ - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare’s Life Sciences business, now Cytiva, in 2013 and has been an actively involved in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development products and services into the Cell and Gene Therapy space.
29 April 10:00AM EDT | 16:00 CEST Register
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, Cytiva introduced Chronicle™ - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare’s Life Sciences business, now Cytiva, in 2013 and has been an actively involved in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development products and services into the Cell and Gene Therapy space.
29 April 10:00AM EDT | 16:00 CEST Register
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, Cytiva introduced Chronicle™ - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare’s Life Sciences business, now Cytiva, in 2013 and has been an actively involved in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development products and services into the Cell and Gene Therapy space.
29 April 10:00AM EDT | 16:00 CEST Register
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, Cytiva introduced Chronicle™ - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare’s Life Sciences business, now Cytiva, in 2013 and has been an actively involved in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development products and services into the Cell and Gene Therapy space.
29 April 10:00AM EDT | 16:00 CEST Register
Are you having challenges with data collection, remote equipment monitoring or digital connectivity? Do you think automation is only for commercial manufacturing? No matter what phase you are, automation can help you accelerate. This year, Cytiva introduced Chronicle™ - a software designed specifically to address challenges in cell therapy. Capable of eSOPs, batch release by exception, visibility of global manufacturing sites, data collection, and more, Chronicle grows with your output and opens new possibilities your current method of paper and pen or decentralized connectivity simply cannot. Join us for a presentation on how Chronicle is revolutionizing the advancements and scalability of cell therapy manufacturing.
George has 15 years’ experience in the cell and gene therapy industry, predominantly in commercial roles supporting academic research through to industrial scale up and manufacture. George joined GE Healthcare’s Life Sciences business, now Cytiva, in 2013 and has been an actively involved in the integrations of the Biosafe and Asymptote businesses. George recently moved from his role as Commercial GM for EMEA, to Global Product Strategy Manager to further support the development products and services into the Cell and Gene Therapy space.