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Accelerate process development on-demand webinar series
The upstream, downstream, and bioanalytical methods and solutions presented in these webinars will help you to:
- Improve efficiency: save time during process development with the latest techniques and ways of working
- Enhance outcomes: increase titers and yields while ensuring robust processes
- Overcome obstacles: address the challenges generated by novel types of molecules
Troubleshooting cell culture media for bioprocessing
An Upstream webinar by Peggy Lio, Director of Process Science, Cytiva
Cell culture media, including basal media and feeds, are key elements impacting the performance of bioprocesses. Advances in cellular and metabolic understanding, coupled with high-throughput applications, have evolved approaches in media development and optimization, resulting in innovative cell culture media with desired characteristics to meet specific needs.
However, challenges associated with the use of cell culture media still exist. Examples include manufacturability, suboptimal stability, inconsistent performance, and/or underperformance in terms of productivity and quality attributes. In some cases, troubleshooting efforts can be guided by learned know-how, but in other circumstances, a systematic approach is necessary to identify the root cause.
Peggy is currently Director of Process Science at Cytiva where she is responsible for leading the technical applications strategy for the US cell culture business. She joined GE from Life Technologies where she was responsible for the development of PD-Direct Bioprocess custom cell line and cell culture media optimization service programs globally. She also led an applications team charged with scientific support of new cell line and media products as well as process development. Prior to Life Technologies, Peggy held roles of increasing responsibility with Schering-Plough Corp., where she ultimately became Section Leader with responsibility for mammalian and microbial fermentation process development for a variety of biotechnology-based therapeutics. Peggy has over 30 years of extensive technical and commercial experience in bioprocessing along with multiple honors and awards from Schering and Life Technologies
Smarter process development of chromatography steps—reducing timelines and improving outcomes
A Downstream webinar by Peter Hagwall Product Strategy Manager, Process Development Tools, Cytiva
Time to experiment, time to clinic, and time to market is becoming even more important for developers and manufacturers of biopharmaceuticals. At the same time, the amount of data enclosed in biologic license applications is more comprehensive to avoid extended review. With projected peak sales of therapeutics only a few years after launch, processes and facilities must be flexible to quickly adjust to a change in demand. Flexibility is also required for changes in capacity, given the uncertain forecast for biologics. Furthermore, as today’s pipelines have an increasing number of more complex and diversified molecules, process development organizations face significant challenges. Smart process development is a collection of approaches to make process development better and faster—providing the developers with tools to face the rapidly changing landscape. This webinar reviews factors that reduce timelines and improve outcomes of process development activities:
- 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. He drives development activities for smarter and faster process development. 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. His interest in purification was sparked when he studied how cellulases interact with cellulose surfaces for his PhD.
A route to deeper process understanding: studying chromatography resin variability using a Process Characterization Kit
A Downstream webinar by Tobias Söderman, Senior scientist, Cytiva
Process robustness and success requires a thorough understanding of critical process parameters (CPP), critical material attributes (CMA), and sometimes interactions between these. Chromatography resin attributes can affect critical quality attributes (CQAs) as well as process performance depending on the process design and the separation at hand.
Ligand density is an important resin attribute that may display interaction with process parameters, such as conductivity and pH.
Resin variability and its potential impact on the process outcome can be studied at various stages in process development. Most commonly, it is addressed in the process characterization study after a suggested process design has been decided upon. This webinar illustrates a cation exchange chromatography process development workflow to assess the potential effect of ligand density variability on product quality and process performance using a Process Characterization Kit. The workflow includes:
- Factor screening
- Process design
- Risk assessment
- Process characterization
Tobias has worked to develop new resin products for the last 20 years. He was involved in the development and launch of Capto S ImpAct, Capto Core 700, and MabSelect PrismA resins, as well as other products. With a background in polymer chemistry, Tobias is able to offer his considerable technical expertise to secure smooth operation of our BioProcess resin production facility.
Challenge analytical complexity–Biacore SPR systems for candidate selection, characterization, and quality control
A Bioanalytics webinar by Michael Murphy, PhD., Cytiva, Marlborough, MA, USA
Biotherapeutic drugs, such as monoclonal antibodies, are large, complex biomolecules whose structural features can impact their biological activity. Several molecular interactions contribute to antibody function and an array of assays are used to select, characterize, and monitor critical quality attributes (CQA) throughout the development process.
Biacore systems for label-free binding assays are used extensively in the biotherapeutic antibody discovery, from development to quality control, giving information for a wide range of applications such as binding, affinity, kinetics, epitope binning, concentration, potency, stability, and many more.
In this technology seminar we present the utility of Biacore systems at all stages of the process from selection of first candidates to clinical lead. We show that a combination of Biacore instruments, software, sensor chips, and kits support the setup of screening and characterization assays, reduces assay development efforts, and shorten and streamline the time to results for decisive decisions.
Michael Murphy joined the Biacore team in 2004 to work as a Biacore Application Scientist for GE Healthcare Life Sciences (now Cytiva) in the mid-Atlantic region of the United States. Prior to that, worked with Biacore technology for 4 years as a customer on the development and characterization of aptamers at the Berkeley Lab’s Joint Genome Institute. Received Ph.D. in biophysics from Case Western Reserve University in 2000
DO NOT USE - Expanding SPR uses in antibody effector function determination
A Bioanalytics webinar by Dr. Stuart Knowling Technical Director, Antibody Analytics, Glasgow, UK
Analytical techniques play a major role in the development of biotherapeutics. Commonly, label-free technology solutions, such as SPR are used in later stages of biotherapeutic development to support the refinement of cell culture and downstream processes that preserve critical quality attributes of the therapeutic protein as well as ensuring a high yield.
Critically, SPR can be implemented at early stages in screening and testing strategies in order to provide better, faster, and stronger analysis of drug candidates. They not only provide information about antigen kinetics and affinity but can also guide selection based on drug candidate effector function. To minimize risk and to get “true” affinity in binding analysis, we have adopted the latest innovation in SPR technology—Biacore 8K system—to develop and qualify assays for monoclonal antibodies and other therapeutic proteins to ensure all critical quality attributes are set and controlled with accuracy and precision. Case-studies will be presented to illustrate how SPR is applied orthogonally in the workflow and successfully used to support the efforts to develop safe and efficient products in an economic fashion.
Dr. Stuart Knowling formarly Technical Director of Antibody Analytics. With over a decade of experience in biophysical protein and nucleic acid production and characterization, comprising both in vivo and in vitro techniques, and included postdoctoral research appointments at University College San Diego and the Scripps Research Institute, La Jolla.
Dr. Knowling has successfully adapted his knowledge of SPR and biophysical techniques to meeting the growing demands of the Biosimilars market. Using SPR-based technologies, namely Biacore 8K, Biacore T200, and Biacore 4000 systems, Stuart has initiated and developed multiple assay formats to characterize biosimilar monoclonal antibody-based therapies as part of larger similarity studies. Initially focused upon characterization of Fc binding characteristics, Stuart has a strong focus on developing target binding assays, potency assays and other non-mAb assay formats to meet the needs of customers at all stages of submission to regulatory bodies.
DO NOT USE - Novel analytics to improve bioprocessing and validation guideline review
A Bioanalytics webinar by Fredrik Sundberg, Global Director, Strategic Customer Relations, Cytiva
A thorough understanding of how the process impacts the product quality attributes is essential for decision-making. Implementation of a robust analytical control strategy with information-rich technologies has the potential to significantly improve characterization and productivity. This presentation provides an overview of how innovative protein analysis tools have been adopted for better comparability, release testing, and impurity monitoring. The presentation also covers the latest regulatory strategies including the new SPR validation guidelines.
As Global Director Strategic Customer Relations at Cytiva, Fredrik is responsible for working with the pharmaceutical industry to improve current workflows with innovative bioanalytical solutions. He also advises on R&D projects and business development activities. Fredrik is author of several publications on drug discovery and biosimilar strategies. He is also member of an EMEA Pharmaceutical Industry Expert Panel, and he lectures and discusses regulatory issues with government officials and health authorities.
Controlling cell culture process variability through supplier enabled data management and analytics.
An Upstream webinar by Aaron Woolstenhulme, Digital Commercial Leader, Cytiva
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.
Rapid cycling protein A based fiber chromatography to address emerging downstream bottlenecks
A Downstream webinar by Dr. Oliver Hardick, Business Leader, Cytiva
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.
Mechanistic modeling: theory to implementation
A Downstream webinar by Thiemo Huuk and Tobias Hahn Ph.D, GoSilico
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:
1) Virus like particles/antibodies methodologies
2) Process characterization and better understanding of design space
3) 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.
Mechanistic modeling: a walk through ChromX software
A Downstream webinar by Thiemo Huuk, Nora Geng and Tobias Hahn Ph.D, GoSilico
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.
Protein A fiber chromatography from research to scale-up and manufacturing of monoclonal antibodies
A Downstream webinar by Anna Grönberg Staff Research Engineer at Cytiva
The new Protein A fiber chromatography format allows for quick purification of many samples because of its short cycle times. This makes the pre-packed, small-scale Protein A fiber unit a versatile tool for processes such as clone selection and up-stream cell-culture media development. The time savings in downstream processes are also significant. Screenings of different buffer conditions and lifetime studies including hundreds of cycles can be performed in less than 24 hours. On the large scale, the Protein A fiber operated in a rapid cycling manner allows full utilization of the Protein A lifetime during one batch.
Examples will be given from small-scale, where automation and a combination of capture and desalting steps will increase the throughput in up-stream process development, as well as buffer and CIP optimization in downstream process development. The compatibility of fiber units with current chromatography systems regarding system flow rates, back pressure limitations, and dead volumes will also be demonstrated. Productivity, throughput, buffer consumption, and purification performance will be compared to traditional Protein A column chromatography.
Anna Grönberg, Staff Research Engineer, joined Cytiva in 2003, and has since focused on the development of chromatography resins for the capture and polishing of mAb and related applications. As a project manager, Anna and her team developed several mAb and other protein processing applications covering Cytiva’s entire downstream product portfolio in close collaboration with customers. Throughout her career at Cytiva, Anna worked with several producers of mAbs and gained a thorough understanding on how modern technology and solutions enable more efficient biopharmaceutical production. As an expert in industrial mAb purification, Anna is currently dedicated to the development of the newly launched Fibro PrismA technology and related industrial applications.
DO NOT USE - Better coverage of your ELISA antibody reagents in host cell protein analysis
A Bioanalytical webinar by Fengqiang Wang, PhD Associate Principal Scientist, Merck & Co.
Host cell protein (HCP) is a significant class of process-related impurity that needs to be removed to adequately low levels during the manufacturing of biological products to ensure product purity and patient safety. Due to its complex composition and low abundance levels in the final product, sandwich ELISA is often used as the workhorse for HCP testing for its high sensitivity and high throughput. However, the detection and quantitation of HCP by ELISA is highly dependent on the capture and detection antibodies used in the method and their HCP coverage. The primary challenge for the ELISA method, therefore, is to obtain specific anti-HCP antibody reagents that can potentially capture and detect all HCPs co-purifying with the biological product. Insufficient coverage from the antibody reagents used in ELISA may leave certain residual HCPs undetected in the final product, leading to immunogenecity and other product safety concerns for patients. Therefore, it is critical to generate process- or platform-specific anti-HCP reagents and qualify the reagents to make sure they have good HCP coverage. In this webinar, we discuss the approaches and steps to obtain reagents with good HCP coverage, from antigen selection for animal immunization, to the use of appropriate methods to determine the reagents’ coverage. We also touch upon the overall HCP analytical control strategy that includes the use of methods orthogonal to ELISA for HCP characterization and analysis. Learning objectives:
- Learn the impact of residual HCP to product quality, safety, and efficacy and the importance of HCP analysis.
- Learn the challenges and limitations of HCP ELISA and why the ELISA reagents HCP coverage matters.
- Learn the steps to obtaining reagents with good HCP coverage, starting with antigen selection for animal immunization
- Learn the overall HCP analytical control strategy and risk management through orthogonal characterization.
This event was originally broadcasted by LabRoots on December 18, 2018.
Fengqiang Wang, Ph.D., is currently an Associate Principal Scientist and Technical Lead in the Biologics Analytical Method Development Group of Merck Research Laboratories (MRL). He started at Merck in 2011 as a senior scientist working on the biochemical characterization of biologics and biosimilar similarity study with originator using a variety of analytical tools such as N-glycan analysis and peptide mapping. Then a major part of his work focused on the development of process- or platform-specific residual host cell protein (HCP) ELISA to support HCP impurity testing in Biologics, including marketed products such as Keytruda and Zinplava. Other than immunoassay development, he also worked on extensive detection and characterization of HCPs and anti-HCP reagents in biologics with 1D/2D SDS-PAGE, 2D-DIGE, 1D/2D-Western blot and 1D/2D-LC-MS. In addition, he is also specialized in assay development for monitoring other process residuals such as protease inhibitors, trypsin, MSX, β-glucan etc. He has authored more than 40 peer-reviewed scientific publications and presented at many national and international meetings including AAPS annual meeting, BEBPA HCP Annual Conferences from 2015 to 2018, BPI, and CHI's Bioprocessing Summit HCP Conference from 2016 to 2017. He also authored several book chapters on antibody engineering and ovarian cancer and had two patents on antibody drug conjugates.
Before Joining Merck, Dr. Wang had devoted almost a decade of his career in ovarian cancer research in the National Ovarian Cancer Early Detection Program run by Dr. David A. Fishman, starting as a post-doctoral researcher in Northwestern University and later on becoming an Assistant Professor in New York University School of Medicine. Dr. Wang received his Ph.D. in Cancer Pharmacology (Microbial and Biochemical Pharmaceuticals) from Peking Union Medical College & Chinese Academy of Medical Sciences in 2002 and was previously awarded an MSc in Medicine and BSc degree in Pharmacy.
Evolution of the Fibro chromatography platform: Scale-up and what is beyond mAbs
A Downstream webinar by Ian Scanlon, Staff Research Engineer at 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.
DO NOT USE - Principles of immunogenicity assessment using Biacore T200 SPR system
A Bioanalytical webinar by Arno Kromminga, PhD, Global Chief Scientific Officer, BioAgilytix and Daniel Worms, PhD, Associate Principal Investigator, BioAgilytix
The assessment of unwanted immunogenicity is a key parameter in the development process of biological protein drugs. Ligand-binding technologies such as ELISA are typically used for early immune responses. Surface plasmon resonance (SPR) technology on the other hand may be utilized for the characterization of antibody isotypes, which have bearing on the interpretation of the clinical consequences of unwanted immunogenicity.
Biacore T200 has an intrinsic module for comparative immunogenicity assessment of biosimilars, which enables an accurate measurement of similarity.
Aspects of when and how to use the SPR technology to obtain a deeper understanding of the unwanted immunogenicity are discussed during this webinar.
Arno Kromminga, PhD, Global Chief Scientific Officer, BioAgilytix. Dr. Kromminga is an esteemed senior expert for the assessment of immunogenicity of Biologicals and is a certified Clinical Immunologist. He and his team have developed and validated numerous assays in immunogenicity and drug monitoring for preclinical and clinical studies. He is a world-leading authority in the area of immunogenicity and co-founder and board member of the European Immunogenicity Platform (EIP), a core member of European Bioanalysis Forum (EBF), and member of multiple scientific societies including the American Association of Pharmaceutical Scientists (AAPS), German Society of Immunology (DGfI), and the German Society of Clinical Chemistry and Laboratory Medicine (DGKL).
Daniel Worms, PhD, Associate Principal Investigator, BioAgilytix. Dr. Worms holds a PhD in Biology and possesses specialized expertise in immunogenicity (ADA), cell-based assays (NAb), pharmacokinetics (PK), and enzymatic assays. He is particularly experienced and knowledgeable on the use of Biacore SPR systems for kinetics and affinity analysis, immunogenicity testing, and pharmacodynamics studies.
DO NOT USE - High-resolution surrogate potency assay using surface plasmon resonance facilitates comparability and biosimilar studies
A Bioanalytical webinar by Veronica Fridh at Cytiva
Biotherapeutic drugs, such as monoclonal antibodies, are large, complex biomolecules with structural features that can affect their biological activity. Several molecular interactions contribute to antibody function and an array of potency assays is needed to measure and monitor critical quality attributes (CQA) throughout the drug candidate characterization process.
In this webinar, we present ways that Biacore assays can be simplified and used as surrogate potency assays to facilitate comparability and biosimilar studies. Specifically, we outline the use of a capture based Biacore assay to simplify assay development. We also demonstrate how this assay can be expanded to include both antigen and receptor binding to estimate relative potency related to several CQAs of a therapeutic antibody in a single sensorgram.
Finally, we address the fact that dose-response curves determined by EC50 or parallel-line analysis only accurately reflect changes in active concentration if binding kinetics remain unchanged. We therefore present a toolbox including:
a) report point analysis for EC50 determination
b) sensorgram comparison functionality to determine whether antibody association and dissociation profiles are consistent with expected binding properties
c) calibration Free Concentration Analysis as a supporting tool, in order to ensure unambiguous determination of relative potencies.
Dr Veronica Fridh holds a position as Global Product Manager and is responsible for Biacore X100 system and for customer training offerings. Previously, she worked for six years as a Scientist at the R&D, Cytiva in Uppsala, Sweden where she focused on Biacore application work in internal development projects such as the development of Biacore 8K. In addition, she supported external collaborations and customer events. Prior to joining Cytiva, she gained user experience of Biacore from both her PhD. studies when she studied protein-protein interactions, and from working with LMW drug discovery at Life Arc (previous MRC Technology), London. She was awarded a PhD in Structural and Molecular Biology from University College London in 2010.
Challenging host cell protein assays for improved risk mitigation
A Bioanalytical webinar by Andrew Hamilton, PhD, Scientist, Imaging and Western Blotting, Cytiva and Joe Hirano, PhD, Program Manager, Imaging and Western Blotting, Cytiva
Host cell proteins (HCP) are critical to quality control in biologics development. If left unremoved, they can cause immunogenic responses and reduce drug efficacy. This presentation will share Cytiva’s strategy for designing a comprehensive HCP risk mitigation strategy. It will address how to challenge your assays early to ensure accurate measurements, build confidence, and reduce the risk of unexpected HCP levels.
Learning objectives:
1. Discuss indicators of robustness and compatibility in enzyme-linked immunosorbent assays (ELISA) with process-specific samples
2. Show how different HCP ELISA kits detect varying HCP levels across commercial drug substances, reinforcing the importance of assay selection
3. Outline ways to measure HCP antibody coverage as required by regulatory authorities
4. Explore the benefits of using a large gel format for reporting coverage data
Andrew Hamilton is a biochemist with a background in glycobiology, protein interactions, and angiogenesis. He joined Cytiva in 2017, where he has focused on developing host cell protein ELISAs and validation assays for the past three years. Andrew received his PhD in cardiovascular medicine from Manchester University in 2011, and then moved to Uppsala, Sweden for his postdoctoral training at Uppsala University.
Joe Hirano is a program manager at Cytiva based in Uppsala, Sweden, where he coordinates products and their applications between R&D and external collaborators to support customers. Since joining the company in 2000, Joe has been working with genomics, protein research, and biomanufacturing products, including electrophoresis, Western blot, imaging, and upstream and downstream bioprocess products. His current focus is on the analysis of host cell protein and other impurities. Before joining the biopharma industry, Joe studied marine biology as a research scientist.
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.