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As our world changes, we remain dedicated to sharing our expertise as your solutions partner in diagnostic imaging, cellular and protein expression research and delivering enabling technologies for large-scale manufacturing of vaccines, biologics and cell therapy.
Although we are adapting to new ways of doing business, we will continue sharing knowledge and ideas in the pursuit of solutions that advance and accelerate therapies for patients.
We invite you to browse our library of on-demand webinars below.
Four Steps Toward Connected Biomanufacturing: A Pragmatic Approach to Start to Finish Processing
Avril Vermunt, Connected Biomanufacturing Program Manager, Cytiva
Watch on-demand Recorded 8 April, 2020
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 Cytiva's strategy for 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.
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, now Cytiva, 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.
KUBio box – Filling the Current Gap in Viral Vector Manufacturing
Ellen Johnson, Enterprise Solutions Technology Leader, Cytiva
Watch on-demand Recorded 15 April, 2020
The industry is experiencing significant growth in cell and gene therapies, fueled by positive clinical results. This growth has created a shortage in manufacturing capacity. Speed, flexibility and potential for future expansion are key elements of a solution. A modular approach with KUBio box, which incorporates a single-use environment, can help to advance and accelerate access to these lifesaving therapeutics.
In Ellen’s role, she identifies new internal and external technologies for incorporation into next generation Enterprise Solutions FlexFactory and KUBio offerings. Prior to joining the GE Healthcare’s Life Sciences business, now Cytiva, Ellen held various process engineering and management roles at Amgen, Inc. She progressed the next generation (single-use) mAb manufacturing platform through design and implementation of innovative technologies related to equipment, automation and consumables. She also developed and maintained corporate (stainless steel) mAb manufacturing platform defining best practices related to process and equipment and participated in new plant start-up activities. She and her teams supported process development, characterization, transfer, validation and monitoring activities. She has acted as process team leader as well as lead process engineer for an entire microbial drug substance process. Additionally, she has authored portions of CMC regulatory submissions and responses to filing questions and inspection observations and presented to auditors from various jurisdictions.
Controlling cell culture process variability through supplier enabled data management and analytics.
Aaron Woolstenhulme, Digital Commercial Leader, Cytiva
Watch on-demand Recorded 22 April, 2020
In drug development and manufacturing, variability in raw materials presents high risks to the success of processes and products. When raw material variability issues arise, manufacturers and suppliers must address them immediately by analyzing data, determining the root cause and minimizing the variability. You can reduce variability across the biopharmaceutical value chain by characterizing raw materials, monitoring materials quality, and controlling raw material usage.
Aaron has 20-years experience working in IT in the cell culture industry, with the last 3 years being spent leading digital transformation efforts. Aaron has a successful track record in designing and building IT solutions to enhance business performance, speeding the flow of information, and collaborating with customers.
Maximize your PD and manufacturing capabilities
George White, Product Strategy Manager, Cell & Gene Therapy, Cytiva
Watch on-demand Recorded 5 May, 2020
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.
Development of a second generation PlasmidSelect resin
Tony Hitchcock, Technical Director, Cobra Biologics
Watch on-demand Recorded 6 May, 2020
To address the growing demand for plasmid DNA, Cobra Biologics have embarked on a collaborative project with GE healthcare to develop a second generation PlasmidSelect resin based on Cytiva’s Capto bioprocessing resin. This presentation with look at the needs within the plasmid DNA market and how this collaboration has sought to address this market opportunity.
Tony has over 35 years of experience in the large-scale manufacture of biopharmaceuticals. As a founding staff member of Cobra Tony has been responsible for the development of much of Cobra’s manufacturing technologies in the field of DNA and virus production. He has held a number of senior roles, managing both manufacturing and development functions within the company, working on over 40 programs for the development of novel therapeutic products including protein, recombinant virus, bacteriophage and plasmid DNA products. His current role is based in the commercial group and support external collaboration and outreach activities. Additionally Tony is currently a member of the BIA Science and Innovation Advisory Committee (SIAC) and of industrial advisory boards for Aston and Loughborough Universities
Rapid cycling protein A based fiber chromatography to address emerging downstream bottlenecks
Dr. Oliver Hardick, Business Leader, Cytiva
Watch on-demand Recorded 13 May, 2020
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.
Implementation of process intensification strategies across the entire cell culture work flow
Andreas Castan, Ph D, Strategic Technology Collaborations Leader, Cytiva
This presentation will describe strategies to intensify upstream operations. We will discuss the latest trends across the industry in relation to process intensification and give specific examples of how both N-1 and N bioreactor operations can be intensified using the latest technologies. Furthermore, we will discuss the importance of cell culture media optimization prior to implementation of any new process.
Andreas Castan is Strategic Technology Partnerships Leader for Cytiva. In this role, Andreas provides leadership and support to the Bioprocess business. His main area of expertise is in upstream processing. Prior to joining Cytiva, Andreas was Director Upstream Development at Swedish Orphan Biovitrum, working with development of expression systems, process development of microbial and mammalian cell-based processes, and scale-up to cGMP manufacturing scales. During the last 20 years, Andreas has held several positions within biopharmaceutical development, including project and line management as well as manufacturing.
Taking Digital Control of Cell Therapy Logistics: An Advanced Therapy Treatment Centre network case study
Bill Shingleton, BSc, PhD, Alliances Manager, Cell & Gene Therapy
Within the manufacturing workflow there are two critical logistics steps 1) transport of the starting material to the manufacturing site and 2) return of the finished product to the treatment center. In this case study we describe work to establish and test a cryogenic logistics pathway for an allogeneic Advanced Therapy Medicinal Product (ATMP). The work was conducted by partners within the Midland and Wales Advanced Therapy Treatment Centre (MW-ATTC). In all, 10 partners participated in the work. These included the ATMP manufacturer, clinical sites, equipment & software manufacturers, and logistics organizations. The transport of the ATMP included both air and road shipments. To simplify the chain of custody and documentation required, a tablet-based system was used. Data from this process and the recording of environmental conditions of the shipments were collected in real-time and relayed to team via a web-based software platform. At the end of the test, the ATMP product was thawed and analyzed for viability and phenotypic markers – this analysis showed equivalence in the transported cells to cells that had remained in storage at the origin site.
Bill is a Biological Scientist, with a research background in inflammation, biology of ageing and connective tissues, and applies this research in the fields of auto-immune, degenerative diseases and oncology. He has gained experience in academia at the Universities of Cambridge and Newcastle-upon-Tyne, combined with 15 years of industrial research with Unilever R&D and GE Healthcare’s Life Sciences business, now Cytiva. Recently, Bill has been supporting the Cell Therapy Industry through the application of in-vivo imaging to enable safety, efficacy and MoA studies, and development of tools and technology for cell therapy manufacturing and cryo-preservation. Currently, he is focused on delivering inputs into the Advanced Therapy Treatment Centres – three consortia who aim to deliver Cell and Gene Therapies into the UK’s National Health Service
Single-use and sustainability: continued studies using LCA tools
Bill Whitford, Strategic Solutions Leader Cell Culture, Bioprocess, Cytiva
The issue of plastic materials in our environment has been of recent interest. The biotechnology community has responded by examining the effects of single-use systems employed in biomanufacturing. It is natural to emphasize a particular set of environmental concerns over others, and especially the more visible ones. But, in supporting truly sustainable manufacturing systems, it is important to consider all relevant types of pollution or environmental stress. The Life Cycle Assessment (LCA) is a science-based approach for evaluating the environmental impacts, benefits, trade-offs, and burden shifts of a process in an objective format. Cytiva has performed a second, extended LCA study of biomanufacturing that considers additional equipment scale, product types, production modes, and installation placements. It compares traditional stainless steel, single-use, and hybrid facilities in the production of Monoclonal antibodies (MAb) and Adenovirus vaccines (Adv), across the full process train including upstream and downstream operations. It includes the effect of many new parameters, including 1) such regional distinctions as shipping distances and power and water sources, and 2) various end-of-life disposal options.
Bill Whitford is Strategic Solutions Leader in Logan, UT with over 20 years experience in biotechnology product and process development. He joined the company as an R&D Leader developing products supporting protein biological and vaccine production in mammalian and invertebrate cell lines. Products he has commercialized include defined hybridoma and perfusion cell culture media, fed-batch supplements and aqueous lipid dispersions. An invited lecturer at international conferences, Bill has published over 250 articles, book chapters and patents in the bioproduction arena. He now enjoys such activities as serving on the Editorial Advisory Board for BioProcess International.
Real-time control executed by in-line sensing
Helena A.M. Öhrvik, PhD, Scientist, R&D BioProcess, Cytiva
Biopharmaceutical productivity and flexibility can be increased by combining single-use technology, in-line sensors, and automated process control. In this study we combined these tools to enhance process control by feedback loops, further reducing manual handling and increasing process robustness. Here, we demonstrate the flexibility of using the single-use Xcellerex™ XDR10 bioprocessing system, an integrated in-line sensor for real-time monitoring and automated in-process control. First, the in-line InCyte probe was used to monitor the viable cell density and control a steady state perfusion via an automated feedback loop controlling the pump for cell bleeding. Viable cell density data was processed with Wonderware™ automation software to accomplish a steady state perfusion by cell bleeding. Second, we combined N-IR in-line monitoring with a feedback loop for glucose control to obtain a fully automated control of this nutrient. At the same time, we received real-time data for lactate, viable cell density, and IgG concentration. The N-IR spectroscopy data was processed in real time, and predicted nutrient concentrations were communicated to the Wonderware software, which controlled a pump on the XDR system. In summary, our data supports use of in-line sensors for better process control in upstream applications. With the thoughtful configuration of sensors and automation software to control multiple process parameters, the XDR system offers flexibility and enhanced in-process control.
Helena Öhrvik is Scientist at Cytiva in R&D. After receiving her Ph.D. in Pharmacology in Uppsala, Sweden, she moved to North Carolina, US, to do her post-doctoral training at Duke University. Her research involved the expression and regulation of recombinant membrane bound proteins in cell cultures. Since Helena joined Cytiva, she has focused mainly on continuous processes, including perfusion, and new inline technologies for the bioprocess field.
Bridging Cell and Gene Therapy Process Development with Next Generation Automation
Shannon S Eaker, PhD, Cell Therapy Tech Sales Leader, Enterprise, Cytiva
As cell and gene therapy processes turn to scalable manufacturing processes, many organizations are learning from previous bioprocess advances in automation and digitization. Adding these advances early in Process Development (PD) activities can provide speed and efficiency when entering technology transfer, clinical trials and commercial manufacturing. Knowledge and expertise from bioprocess learnings in eSOP’s, eBR’s, and facility dashboards can streamline processes, while reducing labor and risks when producing cellular therapies.
Shannon received his PhD from the University of Tennessee, Knoxville in Biochemistry, Cellular and Molecular Biology. His expertise is around T-cell, HSC, and ES/iPSC cell biology, and has been with Cytiva for more than 7 years. He is a member of the International Society for Cell Therapy (ISCT) Process and Product Development (PPD) committee, and has authored numerous papers within the field of cell biology and manufacturing. He is currently the Technical Leader within Cytiva's Cell Therapy Enterprise Solutions group. Shannon lives with his wife and 2 children in Knoxville, TN.
Vaccine production in SU technology – how to maintain closed system processing
Chor Sing Tan, Senior Single Use Technology Applications Leader, Cytiva
Vaccine science has come a long way since Edward Jenner used pus to stop a child from catching smallpox. Synthetic, recombinant, and DNA vaccines have been developed to tackle various infectious diseases. Adoption of cell culture–based systems are also maturing, and vaccine manufacturers are beginning to leverage proven process technology from the broader biotechnology industry to enable multi-product manufacturing in an aseptic manufacturing environment. Single-use technology is one technology heavily adopted by the vaccine manufacturers to meet this requirement. Maintaining processing system closure is one of the key elements of aseptic manufacturing. This presentation will examine key elements of a closed manufacturing system based on single use technology: integrity, bioburden and cleanliness, life cycle of use, boundary and material. Two case studies (final fill and cell cultivation) will be presented with attention given to the uniqueness of single use technology. Examples include use of sensitive integrity test methods such as helium integrity testing, relevance of single-use system shipping test to container closure, and maintenance of single use component design space.
Chor Sing is the Senior Single Use Technology Applications Leader ay Cytiva. In this role, Chor Sing provides leadership and strategic guidance to the Bioprocess business. His main area of expertise is in adoption and implementation of single-use bioprocessing technologies, and he often acts as customer advocate in execution alignment. Since joining Cytiva, Chor Sing has served in several business and science functions including sales, marketing and scientist roles in bioprocess technologies involving modular manufacturing solutions, bioreactors, chromatography, protein expression and filtration. Prior to joining Cytiva, Chor Sing was Senior Scientist and Bioprocess Engineer for CSL Behring with expertise in blood plasma processing. Chor Sing received both his Ph.D. degrees in chemical and biomolecular engineering from the University of Melbourne, majoring in novel protein separation and biopolymer engineering.
A scalable adeno associated virus production process, from cell culture to purified bulk
Åsa Hagner Mcwhirter, Senior Scientist, Cytiva
Adeno-associated virus (AAV) vectors are increasingly being used in clinical trials for gene therapy applications. Manufacturing of safe and efficacious clinical-grade virus relies on a scalable and cost-effective production process. In this study we have combined experimental work and process economy calculations to develop an efficient and scalable process for AAV production. Each process step, from AAV production in suspension cell culture to purified bulk product up to the 10L scale, was evaluated and optimized. We used AAV2 for process development, since this is the most used AAV vector in addition to serotype 5, 8, 9, and various synthetic capsid variants. AAV2 expressing green fluorescent protein (GFP) was used for process development to facilitate analysis. First, suspension culture of HEK 293T cells adapted to serum-free medium and triple plasmid transfection were optimized using a DoE strategy for transfection efficiency and AAV2 production. The conditions were further developed for production in a single use stirred tank bioreactor system. Novel affinity and ion exchange based purification step alternatives were compared, including different chromatography resins and membrane formats. Finally, ion exchange chromatography and core bead technology were evaluated as an alternative to size exclusion chromatography for the polishing step before the formulation into storage buffer. Analytical methods for virus titer are challenging and depend on purity and quality of the sample. For viral genome titer qPCR was used and for total virus titer ELISA and HPLC methods were used. For infectious virus titer, we used a flow cytometry-based assay counting GFP producing cells. Based on analytical data different downstream process alternatives were compared regarding load capacity, recovery, reduction of empty capsids, and purity. We propose a robust and scalable process with a favorable process economy.
Bio: Åsa is a Senior Scientist at GE Healthcare’s Life Sciences business, now Cytiva, in Uppsala, Sweden. She has been 17 years in R&D focusing on applications and product development within downstream purification and analytics. During the last 4 years she has been working with viral vectors. In her current role, she is a team leader for several research projects and customer collaborations. Previously, she worked with proteomics and fluorescent based protein analysis. Prior to joining GE Healthcare’s Life Sciences business, now Cytiva, Åsa did a PhD and a post-doc in Medical Biochemistry at Uppsala University within the field of Glycobiology.
Evolution of the Fibro chromatography platform: scale-up and what is beyond mAbs
Ian Scanlon, Staff Research Engineer, Cytiva
Fibro chromatography for scalable monoclonal antibody (mAb) purification was recently launched to address the evolving needs of drug developers and manufacturers. This single-use technology uses a highly alkaline-stable, engineered protein A PrismA ligand. The rapid cycle times, which Fibro chromatography enables, present a new paradigm for process development. Hundreds of process parameter conditions can be investigated each day using ÄKTA™ chromatography systems and UNICORN™ control software. For large-scale manufacturing, the technology offers new processing strategies with processing of about 15 kg mAbs per day. Here we will showcase the technology’s current state and outline the roadmap for future development of the platform. We will show data from large-scale protein A capture Fibro units for GMP-regulated work. The integration of the Fibro capture step into a complete mAb process will also be shown. We will discuss future developments regarding other ligands and applications for the fiber matrix, including mAb polishing, capture and resolution of larger therapeutic complexes.
Ian Scanlon has over 20 years experience in separation and chromatography, ranging from small molecule therapeutics, through modified triphosphates, DNA and proteins. For the past five years Ian has been part of the development of the Fibro Chromatography technology, working with groups across biopharma in the EMEA and the US to develop applications.
A Pragmatic Approach to the Buy vs Build Manufacturing Dilemma
Joseph Phillips, Ph.D. - Senior Vice President & Head of Pharmaceutical Development ArmaGen, Inc.
Nacim Haderbache - Commercial Strategy Leader Cytiva
Carol Houts, Director of Regulatory Affairs, Germfree, Inc.
The decision to outsource manufacturing or produce a therapeutic product in house plagues many biopharmaceutical executives. Each decision requires a careful assessment of multiple variables such as timelines, IP protection, forecast, capital allocation, technical capabilities, and market strategy. Every situation is unique and typically requires compromises and often results in valuable lessons learned. In this webinar you will be presented a case study of one economic assessment of a buy versus build decision model. The panel will discuss other scenarios to generate a useful discussion of the possible options and the potential outcomes.
You will learn:
- Financial modelling of buy vs build scenarios
- Considerations when manufacturing at a CM
- Benefits of outsourcing or insourcing
- In-house manufacturing options for retrofitting existing structure, stick-built or modular builds
- Technical challenges when manufacturing gene therapies
Four Steps Toward Connected Biomanufacturing: A Pragmatic Approach to Start to Finish Processing
George White, Product Strategy Manager, Cell & Gene Therapy, Cytiva
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.
Four Steps Toward Connected Biomanufacturing: A Pragmatic Approach to Start to Finish Processing
George White, Product Strategy Manager, Cell & Gene Therapy, Cytiva
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.
Four Steps Toward Connected Biomanufacturing: A Pragmatic Approach to Start to Finish Processing
George White, Product Strategy Manager, Cell & Gene Therapy, Cytiva
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.