Platinum Sponsor
Cytiva
Cytiva is a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare Life Sciences, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Our customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services they need to work better, faster and safer, leading to better patient outcomes.
Cytiva is a global life sciences leader with over 7000 associates across 40 sites who are dedicated to our vision to improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.
Associated Experts
Job Title: bioprocess hardware specialist
Job Title: Global Product Marketing Manager BioProcess Chromatography Resin
Job Title: Applications Specialist
Job Title: Global product manager ReadyToProcess™ columns
Job Title: Global Product Marketing Manager
Job Title: Modality Manager, BioProcess™ Hardware
Job Title: Business Leader, Chromatography Resins
Job Title: Senior scientist
Job Title: Global Product Marketing Manager
Job Title: Material Science Leader in BioProcess R&D
Job Title: Senior Scientist
Associated Content
Cytiva™ Protein Select™ Resin – A new affinity resin for recombinant proteins
Cytiva™ Protein Select™ resin is an affinity chromatography resin for purifying recombinant proteins using the self-cleaving Cytiva™ Protein Select™ tag. This technology simplifies tagged protein purification when used in research and standardizes purification during process ... Continued
f(x) Columns for Mechanistic Chromatography Modeling
Mechanistic modeling is an approach that uses computer simulations based on known physiochemical phenomena to understand and describe a variety of chromatographic modes. These simulations can effectively decrease the number of physical experiments that need ... Continued
ÄKTA ready™ Chromatography Systems from Cytiva
In the current landscape of biopharmaceuticals, single-use technologies are being increasingly incorporated into bioprocessing workflows. They offer several benefits such as enhanced manufacturing flexibility, reduced risk of contamination, and decreased downtime that can streamline process ... Continued
Cytiva MabSelect™ VL protein L affinity resin
Monoclonal antibodies (mAbs) represent a rapidly growing class of therapeutics designed to target and bind to specific proteins to treat a variety of diseases, including cancer, autoimmune disorders, and infectious diseases. They can be custom ... Continued
Cool Tool – GoSilico™ Chromatography Modeling Software from Cytiva
Biopharmaceutical manufacturers are continuously striving to find efficiencies and make improvements across downstream processing steps to improve product quality, reduce costs, and accelerate the development of safe and effective biopharmaceuticals. Chromatography plays a critical role in ... Continued
Fit for Purpose AAV Purification – Realizing the Perfect Scale for Cell and Gene Therapies
The explosive advancements within the cell and gene therapy sector have the driven the demand for high-quality GMP-compliant viral vector manufacturing. Adeno-associated virus (AAV) has been the primary vector driving this growth, as well as ... Continued
Addressing Downstream Throughput Bottlenecks with Rapid Cycling Protein A Based Fiber Chromatography
In closing, the Fibro units offer new flexibility and cost efficiency throughout multiple stages of product development. They compliment resin-based chromatography by providing benefits that resin-based chromatography doesn’t offer. In research and process development, Fibro’s faster purification can reduce development timelines. In clinical development, cost can be reduced by utilizing Fibro’s full Protein A lifetime in one batch. In manufacturing, Fibro’s cost-efficient single-use chromatography delivers more batches per year and allows large capital chromatography investments to be delayed until financial risks are reduced....Continued
Single-Use Tangential Flow Filtration (TFF) Offers Advantages for Viral Vectors and Vaccines
Implementing single-use systems like the ÄKTA readyflux systems, enables rapid deployment of facilities to build capacity quickly and the flexibility of the system permit them to be connected with existing equipment. It also significantly reduces CIP and validation steps that speeds change-over between campaigns. Automation increases the speed, monitoring, and consistency of the process....Continued
Automated Buffer Preparation – Increasing Production Capacity While Maintaining Footprint
How can buffer preparation be more efficient and not require footprint expansion. Is there a way to increase manufacturing capacity without increasing footprint and time spent on buffers?...Continued
Scalable Protein A Chromatography for High-Throughput Process Development
The paper describes two case studies where authors demonstrate how the use of Fibro units functionalized with protein A at 0.4 mL laboratory-scale and 60 µL 96-well plate format can be used complementary....Continued
Utilizing High-Throughput Process Development Tools to Create a Purification Process for a Biosimilar Molecule
By working in collaboration and sharing expertise, high throughput tools were incorporated into process development for a purification process specifically tailored to meet the needs of this biosimilar. Using the Fast Trak standardized workflow meant initial running conditions were identified in just four weeks for further process development....Continued
High Throughput Process Development in Biomanufacturing – Current Challenges and Benefits
We were also fortunate to be able to interview one of the conference chairs, Mats Gruvegard, GE Healthcare Life Sciences about what he saw as key takeaways from the conference and where he sees the future of high throughput process development heading....Continued
Start With The End In Mind. How to facilitate transfer from non-GMP to GMP Manufacturing
Avril Vermunt, bioprocess hardware specialist at GE healthcare talks about transferring a process from non-GMP to GMP manufacturing, particularly how resource-intensive it is for process development and manufacturing groups. Avril has several years of experience working in the technology transfer group at a large pharmaceutical company. We discussed with her best practices and how being proactive and one step ahead can make the process more seamless....Continued
Intensify Process Development Steps and Simplify Transfer to GMP Environment with New ÄKTA Pilot 600 Chromatography System
The strive to shorten time to market is constant, which puts pressure on the entire drug development process from research to manufacturing. With more drugs in pipeline, biomanufacturers need flexibility, efficient changeovers, and accelerated scale-up and transfer to the next development phase....Continued
Flexible Downstream Platform Facilitates Adaptation to Scale
The presented examples demonstrate that a downstream platform comprising one column diameter, but including columns of three different bed heights, can be used with minimal adjustments to process varying upstream titers....Continued
Integrating Downstream Unit Operations – Polishing and Concentration Steps
Integrating downstream unit operations provides many process benefits, including a reduction in the amount of manual operation and resources. The connection of unit operations also minimized intermediate hold steps and provided an overall reduction in process time. Key advantages of using this combination of equipment and software were 1) unit operation can be ran automatically and in parallel saving time 2) the use of single-use flow paths eliminated the need for costly and time-consuming cleaning and cleaning validation....Continued
Addressing Challenges in Downstream Biomanufacturing with a Platform Purification Approach
Jonathan Royce, Business Leader, Chromatography Resins, GE Healthcare Life Sciences, talks about the biggest challenges in Downstream biomanufacturing including overcoming bottlenecks, changing antibody structures and bioburden control. Jonathan shared how a purification platform can address some of these issues and discusses purification challenges that still need to be resolved....Continued
Protein A Chromatography – A look at where we have been and where we are going
Jonathan Royce, Business Leader, Chromatography Resins, GE Healthcare Life Sciences, talks about the evolution of Protein A including the latest developments in Protein A chromatography resins. We also discussed what the future holds for this purification mainstay and how it can continue to address the changing needs of biopharma....Continued
Resolving Large Scale Buffer Management Challenges
Joakim Lundvist, Modality Manager, BioProcess™ Hardware, GE Healthcare talks about large-scale buffer management challenges. Buffer preparation is known to be one of the most resource-intensive activities in biomanufacturing as large volumes of buffers and process liquids are often required. So how can this be done in a more efficient way? How can more capacity be added to buffer preparation without adding major capital investment? Are there ways to reduce the manufacturing footprint and time spent on buffers?...Continued
Enabling Antibody-drug conjugate manufacturing using single-use systems in downstream – Extractables study demonstrates a good fit
The low levels of extractables found in this study demonstrate chemical compatibility of ReadyToProcess columns and ÄKTA ready Flow Kits with two organic solvents typically employed in ADC manufacturing processes, DMSO and DMA....Continued
Automated, single-use filtration to increase efficiency in upstream and downstream operations
In examining ways to improve overall bioprocess efficiency, filtration is a step that can sometimes be overlooked. However, it is a key area to improve efficiency, as it is part of both upstream and downstream operations and consumes sizeable resources. The application of single-use technologies coupled with increased automation have successfully improved efficiency in other bioprocess operations, thus it is logical that filtration would also benefit from these technologies. One example of an improved filtration solution is GE Healthcare’s ÄKTA™ readyflux filtration system. The ÄKTA readyflux combines automation and single-use crossflow (tangential flow) filtration and is suitable for pilot and small-scale manufacturing....Continued
Bioburden Contamination in Downstream Bioprocesses – Potential entry points for contamination and innovative solutions
While bioburden contamination remains a major issue in biopharmaceutical manufacturing there are strategies available that can reduce the risk of introduction. There are also products and technologies in development that may reduce the risk further and/or enable more robust sanitization processes to improve sanitization in the future....Continued
Impact of Continuous Chromatography Mode on Protein A Resin Lifetime
The presented data demonstrates that PCC does not compromise the performance of MabSelect SuRe LX or MabSelect SuRe pcc over the performed 175 cycles, supporting the use of this technique to improve resin capacity utilization against batch processing. While the performance indicators (HCP, leached Protein A, and mAb content in eluate) were comparable between the resins, MabSelect SuRe pcc demonstrated an approximately 25% higher mAb binding capacity compared with MabSelect SuRe LX under the conditions used. The results confirm that the use of a resin designed for PCC can help improve economy of continuous processes even further....Continued
Optimize Changeover Workflows with ÄKTA readyflux – An Automated, Single-use Crossflow Filtration System
GE Healthcare has combined these efficiencies in the ÄKTA readyflux, a next generation, automated, single-use crossflow (tangential flow) filtration system for pilot and small-scale manufacturing. The system features a single-use flow path that minimizes the cross contamination risk, reduces the need for cleaning, and shortens the batch change-over time. In addition, automated filtration protocol capabilities in both upstream and downstream applications simplify automation implementation. Automation capabilities include extensive monitoring and control functions....Continued
Cost and impact of a bioburden incident
A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks....Continued
Antibody Fragment Purification Platform
Antibody fragments are also being explored for use in antibody drug conjugates where a full length antibody or an antibody fragment is linked to a cytotoxic agent designed to kill target cells when internalized and released; antibody gene therapy applications; and antibody fragments are also being linked with liposomes or nanoparticles to improve drug delivery....Continued
Addressing Buffer Bottlenecks using automated In-line conditioning and ready-made stock solutions for mAb processes
Automation both saves time and minimizes the error risk with manual buffer preparation, ensuring consistency between batches. The built-in dynamic control functionality assures the accuracy of the buffers produced. In addition, using ready-made, highly concentrated, low-volume stock solutions, further increases efficiency by saving time and space in buffer preparation and minimizing the need for raw material qualification....Continued
Scale up with confidence – Introducing ReadyToProcess 32 L (450/200)
To meet these needs GE Healthcare is now introducing ReadyToprocess™ 32 L (450/200) for manufacturing-scale purification of biomolecules from bioreactor harvests of up to 2000 L. ReadyToProcess columns are delivered prepacked, prequalified, and pre sanitized to enable significant time savings in biopharmaceutical production....Continued
Fortem: A platform film built for bioprocess
Fortem was designed specifically for bioprocess applications and GE Healthcare partnered with Sealed Air Corporation, a manufacturer of primary films for pharmaceuticals, in the design and manufacturing. In addition, GE material science experts worked closely with customers to design a film that would meet the critical quality attributes required for a platform bioprocess film....Continued
Increasing Downstream Bioprocess Efficiency and Overcoming Bottlenecks
In summary, there are many new, enabling technologies to increase efficiency and decrease bottlenecks in downstream. The approach of viewing each of these as a tool to be used to solve specific challenges either in tandem or on their own seems to be a logical approach. In this manner, the entire process does not need to be overhauled all at once, but rather in steps as needs arise. It is also important to keep these tools in mind while designing new facilities as the flexibility that these technologies provide will help create a facility that can change with time to meet ever-evolving industry needs....Continued
Gain Productivity in Protein Purification through Column Loading Optimization
Utilizing variable RTs can significantly increase productivity, while maintaining capacity and purification performance. Theoretical modeling, constructed with knowledge of the DBC vs RT curve, showed nearly identical results to the experimental study....Continued
Evaluating Plastic Film for Single-Use Technologies in Biomanufacturing
We recently finished our Ask the Expert discussion on Considerations in evaluating new plastic film for single-use technologies and film development. During this Ask the Expert session, we discussed film selection topics including partnering with suppliers to select and develop industry applicable films, leak resistance, shelf life, films for vaccine manufacturing, and films when lipids are present in media. Other topics included extractables and leachables testing, risk assessments, scaling up or transitioning to single use, film standardization....Continued
Considerations in Evaluating New Plastic Film for Single-Use Technologies and Film Development
The increase in adoption of single-use bioprocess technology for manufacturing biopharmaceuticals has been driven by the many advantages it offers, such as increased flexibility. However, the materials of construction can be more complex than conventional stainless steel vessels. ...Continued
Protein A – Evolution and Optimization Strategies
While Protein A chromatography has remained a constant in monoclonal antibody production since the 1980’s it has had to undergo regular redevelopment and next generation versions to keep up with changing demands in biomanufacturing. These improvements need to continue, if Protein A is expected to continue to maintain a large share of the purification market....Continued
GE Healthcare Completes Acquisition of Three Thermo Fisher Scientific Business Divisions
On Monday, GE Healthcare announced completion of their acquisition of Thermo Fisher Scientific’s HyClone cell culture media, sera and process liquids; Dharmacon RNAi gene modulation tools; and Sera-Mag magnetic beads businesses. In January, GE Healthcare and Thermo Fisher Scientific announced that they had entered into an agreement, which would allow GE to acquire these businesses for approximately $1.06 billion. This was a win for both businesses in that it expanded GE’s Life Sciences product portfolio and enabled Thermo Fisher’s European approval of its $13.6 billion Life Technologies acquisition...Continued