Articles
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New drug process development
Meeting the process development challenges of a diverse biologic pipeline How to navigate the evolving biopharmaceutical landscape from a process development standpoint.
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14 questions and answers on Fibro technology
Here we highlight and respond to the most common questions raised during the webinar: Rapid cycling protein A based fiber chromatography to address emerging downstream bottlenecks
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6 habits for keeping your lab equipment in good shape
See what simple habits can have an outsized impact on the reliability and longevity of your lab equipment.
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A small-scale model to increase yield in cell culture perfusion of mAb at large scale
Small-scale model for a monoclonal antibody (mAb) cell culture perfusion.
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Accelerate flavivirus vaccine production
As with all viral vaccines, the complex nature of flaviviruses makes process development technically challenging. This article addresses how modern bioprocess tools and solutions can accelerate flavivirus vaccine production
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Accelerating an orphan therapy to market
This case study highlights how our Fast Trak Services team to help accelerate process development for cGMP production of material for toxicology studies.
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Achieving operational efficiency in today’s fragmented market
Improving bioprocess efficiency is key to succeeding in a fragmented market. Use the latest technologies and solutions to do it without sacrificing flexibility.
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Amgen: Linking raw material data from suppliers to patients
By collaborating openly across the industry, we can minimize and control raw material risk and better manage our supply chain for the purpose of delivering the safest and most effective drugs possible.
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Analysis of Fortem bioprocessing film
Fortem™ single-use bioprocessing film technology: cell growth, carbon dioxide and oxygen transmission rates, flex fatigue, and other analyses.
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Automated high throughput mAb purification using Fibro technology
Total run time was reduced 3- to 6-fold with Fibro PrismA. Recovery and critical product quality attributes were comparable to columns packed with MabSelect PrismA resin.
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Bacterial capsular polysaccharides
Purification platform for vaccine production
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Best practices for a successful bioprocess technology transfer
A well-executed bioprocess technology transfer (tech transfer) is critical to ensure smooth knowledge transfer and optimal process reproducibility. If not executed properly, you risk reducing the quality and efficiency of your process.
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Bioburden control
Addressing microbial contamination
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Biopharma: Addressing talent crunch in a growing industry
Gaining a skilled labor force in the growing biopharma industry can be a challenge. So what strategies should your company be considering for recruiting, training and retaining qualified bioprocessing candidates.
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Biopharma: How to win in emerging markets
Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?
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Bioreactor oxygen
Importance of aeration and ways to control kLa during cell cultivation
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Bridging the skills gap in biopharma
The growth of the biopharmaceutical industry depends on skilled workers. Routine training programs can help employees’ capabilities to effectively execute on process development and manufacturing operations.
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Buffer management solutions for large-scale biomanufacturing
Learn ways to resolve bottlenecks in the manufacturing process caused by buffer preparation.
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Building A Better Film For Single-Use Bioprocessing Through Effective Partnering
Choosing the right partner is key to addressing the challenges of implementing single-use technology.
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Can a shared biomanufacturing facility be the answer?
With a shared biomanufacturing facility, you can mitigate the risks of demand uncertainty using a flexible solution that allows you to grow and change in the new paradigm of biomanufacturing.
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Case study: high throughput mAb purification with Fibro
A drug discovery lab finds that purifying antibodies with Fibro PrismA units means they can screen more candidates per week with a simpler equipment setup.
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Case study: virus reduction of an affinity capture step
This case study describes a successful viral clearance study for a protein A chromatography biomanufacturing step.
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Cell culture titer and protein quality
How media composition can maximize protein yield and quality attributes
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CDMO or no CDMO . . . that is the question
By checking the pulse of your organization first, it is possible to identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.
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Collaborating to accelerate vaccine development
As the pharmaceutical industry continues to look for new and innovative ways to treat disease, some companies are putting more focus on how to prevent them.
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Column packing methods for MabSelect PrismA resin
Good column packing is essential for any chromatographic process. This procedure includes robust and verified packing and testing methods that will help eliminate concerns and risks associated with poorly packed beds.
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Concentrated fed-batch
Intensify your process by going from cell vial to 2000 L bioreactor in 1 step
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Connect and automate for efficiency
Data connectivity and comprehensive automation ease bioprocess tech transfer and scaling from process development to final manufacturing scale.
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Connected automated downstream process for mAb screening and evaluation
Learn about how a continuous automated process can save significant time and effort while maintaining product quality.
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Continuous chromatography
PCC chromatography + straight-through processing = intensified
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Developing a closed connected single use mAb purification process
Explore a developed closed connected downstream purification process and learn how new technologies can provide improvements
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Developing a new biologic drug: regulatory challenges and considerations
Key milestones and planning ahead for compliance when bringing a new biologic drug to market.
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Digital aids productivity and growth
Digital technologies can improve productivity and growth in cell therapy manufacturing and in bioprocessing.
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Digital manufacturing of biologics
The recent explosion in monitoring, analytics and new computing capabilities initiated the revolution called digital biomanufacturing. Learn how it can help biomanufacturers to improve their manufacturing processes.
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Digital transformation in biomanufacturing
Industry 4.0 uses digital connection and advanced analytics to improve bioprocess productivity. Digital transformation is how to get there. A Cytiva and Biogen case study illustrates the value.
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Doubling up for speed in biomanufacturing
Parallel operations affords the opportunity to develop a process in a parallel path using the resources of an external CDMO partner while simultaneously establishing your manufacturing capabilities.
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Dry powdered medium milling equivalency study
Study compares powdered cell culture medium production using Sturtevant and Hosokawa pin mills. Physical, chemical, and biological data including cell growth.
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Efficient and scalable buffer preparation
Two ways to use the quaternary valve of an ÄKTA avant chromatography system for buffer preparation – scale up to an inline conditioning system or scale down for robustness studies.
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Efficient protein A chromatography for bispecific antibodies
Bispecific antibodies (BsAb) can be purified using protein A chromatography in only a single step. BsAb constructs were efficiently purified to give more than 90% purity and 85% yield in the early screening downstream process.
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Evaluating leachables from extractables data
A practical approach on how to use supplier extractables data and best practices to assess leachables risk over a complete 2000 L single-use manufacturing process
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Evaluating the economics of today’s biomanufacturing strategies
Buy vs build: what is the best strategy to establish and maintain efficient and productive manufacturing operations? Here is what ArmaGen decided to do.
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Fermentation
Which offers better process economy and production capacity: single-use or stainless?
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Fiber-based protein A chromatography for HTPD
Study evaluates research-scale units and 96-well plates in applications for high-throughput monoclonal antibody purification.
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Filtration
How to efficiently concentrate a low-titer antibody sample
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Flavivirus vaccine
Accelerate production with modern tools and solutions
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Flow and gradient accuracy using ÄKTA pilot 600 system
Accurate flow and gradient performance are important to provide reproducible chromatography results at different scales. In this study we investigated flow and gradient accuracy of the ÄKTA pilot 600 chromatography system.
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Gain efficiency in process development
Learn how fellow scientists use ÄKTA avant to gain efficiency in protein purification process development
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How the industrial internet of things is transforming Bioprocessing
Digitalization means a more productive and adaptive plant through the application of analytics…
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Large-scale perfusion cell culture
We have sucessfully conducted a large-scale scale perfusion run using Xcellerex APS connected to an Xcellerex XDR 50 bioreactor.
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How to do a multiple peak comparison in Fibro chromatography
Learn how to perform a multipeak comparison for Fibro chromatography units. We demonstrate ways you can generate large numbers of chromatograms and directly gather a great deal of data from each run.
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Improve PD efficiency
Time to experiment, time to clinic, and time to market are becoming even more important for developers and manufacturers of biopharmaceuticals. Here we give some insights on tools to make process development more efficient.
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Increasing productivity in hydrophobic interaction chromatography (HIC) using Capto resins
In this study we demonstrate productivity gains using Capto resins in hydrophobic interaction chromatography. Relative hydrophobicity of a resin is dependent upon sample composition, emphasizing the importance of testing resin hydrophobicity for each biomolecule.
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Influenza vaccine
Production process using single-use bioprocessing equipment
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Integrating automation in a biomanufacturing environment
Integrating automation can become a daunting task without the right preparation and a clear implementation strategy. Through proper planning, you can eliminate costly errors and missteps.
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Intensified chromatography strategies
Explore downstream operations to improve biomanufacturing productivity, speed, and flexibility. Options include improved resins, prepacked columns, continuous chromatography operations, and fiber-based chromatography.
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Is your single-use facility designed with the end in mind?
Up-front design considerations can improve your long-term processing flexibility and ability to expand
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Manage process development data
Data management is a key element of the drug development process. Learn about the challenges of today’s methods and new solutions to successfully overcome them.
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Manufacturing of viral vectors
For use in gene therapy and development of therapeutic vaccines
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Lessons learned executing a closed connected processing from start to finish
Insights and recommendations for designing and executing a connected single-use , perfusion monoclonal antibody manufacturing process. These findings are based on a practical process run at 50 liter scale.
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Mechanistic modeling of chromatography
This article explores the opportunities and challenges with using mechanistic modeling for chromatography.
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Monoclonal antibodies
Intensify downstream processing of mAbs with innovative, integrated approaches
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Multidimensional scale-up using ÄKTA pilot 600 system
In this study we demonstrate a 20-fold multidimensional mAb capture step scale-up. Read how equivalent mAb recovery and purity was achieved between the larger and smaller scales using an ÄKTA pilot 600 chromatography system.
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Next generation bioprocesses: Mapping roads to the future
Explore available options to select a path based on molecule and facility needs
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Overcome chromatography challenges with fiber adsorbents
Innovative technology for chromatography process scale-up.
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Perfusion culture with ATF cell retention
Perfusion culture of an antibody-producing CHO cell line, with alternating tangential flow filtration (ATF) for cell retention. Uses an XDR-10 bioreactor system, hollow fiber filter cartridge, and diaphragm pump.
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Perfusion culture with TFF cell retention
Perfusion culture of an antibody-producing CHO cell line, with tangential flow filtration (TFF) for cell retention. Uses an XDR-10 bioreactor system and hollow fiber filter cartridge as cell retention device.
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Preparing for the future of biomanufacturing
New market dynamics are reshaping how biologics are produced and sold. Here’s what six industry experts say about the way forward.
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Process considerations for closed connected processing
Considerations for aligning design space for multiple connected single-use processes to ensure operational flexibility and efficiency resulting in a high quality product.
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Purification of plasmid DNA
Collaborative Development of a Next-Generation Chromatography Resin for the Purification of Plasmid DNA
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Purposeful design and development of a next-generation single-use bioprocess film
Biomanufacturing requires a film technology specifically designed for working with biologics.
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Raw material variability: the need for deeper process understanding
The importance of resin variability characterization for obtaining robust chromatography polishing processes
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Resin slurry concentration
Accurate determination for optimal column performance
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Risk assessment: when to study chromatography resin variability
How do you identify which parameters and interactions to focus on in your process characterization studies?
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Robust business continuity program helps to maintain operations in the face of crisis
A business continuity management strategy is key to reducing risks and downtime, and maintaining quality. Cytiva has implemented several initiatives to help mitigate risk and ensure security of supply in the face of global challenges.
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Sanitization: AxiChrom columns
Peracetic acid (PAA) was evaluated as sanitization agent in the packing and repacking of a protein A resin in AxiChrom 300 column.
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Sanitization of the ÄKTA pilot 600 chromatography system
In this study we evaluated the predefined sanitization methods for the ÄKTA pilot 600 chromatography system.
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Scalable ADCF virus production using HyClone VaccineXpress medium
HyClone VaccineXpress cell culture medium promotes the production of inflective influenza…
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Scaling a mAb production process to Xcellerex bioreactors
Moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform
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Securing bioprocess film supply
Transparency across the single-use film supply chain helps to ensure security of supply for single-use bags.
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Securing today’s biomanufacturing supply chain using transformative supply
Compared to just a decade ago, managing the biopharmaceutical supply chain has become a far more complex topic.
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Single-use chromatography
Adapting to manufacturing scale
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Single-use technologies are here to stay. How can we improve their supply
The use of single-use technologies has been growing steadily, but supply constraint is a key challenge for the biopharma industry. This article discusses the potential solutions for improved supply.
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Strategies for viral vector manufacturing
Accelerating the production of viral-vector based therapy requires both understanding of strategies available to address the viral vector manufacturing shortage and how to select the most cost-effective solution for your next-generation therapeutic.
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Studying resin variability using a Process Characterization Kit
Learn how variability of resin ligand density may impact product quality and process performance.
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Suppliers' contributions to bioprocessing advances
From platform processes to disruptive technologies: The future of innovation continues.
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Supply chain raw material variability
Increased development of biological drugs has reinforced the demand for heightened material controls. Raw materials like cell culture media can have a major impact on the robustness of the biomanufacturing process and, ultimately, on the drug itself.
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The antibody boom
Antibodies continue to dominate the biopharma market. Analyzing the strategies employed by successful players in the field could provide invaluable lessons for those hoping to enter it.
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The good and bad of biosimilars
The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.
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The path to immunoassay reagent development
Guidelines for developing immunoassay reagents using technolgies such as Biacore surface plasmon resonance
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Towards a better process outcome
Considerations for improving outcome in biopharmaceutical process development
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The transparent CDMO
Handing over vital information about your product can be very unnerving. That is why it is important to find a CDMO who can help alleviate drug development risks and protect your intellectual property (IP).
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Understanding and controlling raw material variation in cell culture media
Manage variability through advanced analytical methods and risk-based assessment
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Using in-line sensors for real-time control
This paper exemplifies how to use available and reliable sensors for in-process control of several different upstream and downstream process parameters.
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Vaccines
Accelerate cell-based vaccine production with modern tools and solutions
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Vaccines: A balancing act
Although absolutely crucial for maintaining global health, vaccines are challenging to develop and manufacture. How can businesses ensure profitability while maintaining low prices for developing countries?
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Viral clearance study basics
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. Here is an overview of the fundamentals of viral clearance studies related to the chromatography steps in a bioprocess.
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Wonderware automation for the Cytiva FlexFactory
At the heart of FlexFactory, bioprocess automation drives unit operations in bioprocess installations. The central nervous system of FlexFactory, bioprocess automation coordinates control and consolidates data
Tools
Webinars
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Automation solutions
Automation in process development and biomanufacturing
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Risk management
Sustainable supply and risk management programs: challenges and considerations
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Single-use – impact on operations
Shire and Cytiva discuss impacts and propose solutions for successful MES implementation
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Troubleshooting cell culture media for bioprocessing
A systematic approach to identifying and solving cell culture media challenges earlier in your bioprocess workflow.
Videos
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5 key considerations for creating cGMP single-use biomanufacturing capacity
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500 L single-use Xcellerex microbial fermentor
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Chronicle™ Software: Scaling for needs in cell therapy
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Chronicle™ Software: Automating batch records
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Chronicle™ Software: Mitigating risks in production
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Fortem single-use platform film built for bioprocessing
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KUBio: The proven response for rapid biomanufacturing
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ReadyToProcess prepacked, validated columns
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Rehydrating powder media with Xcellerex mixers
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Single-use TFF system: ÄKTA readyflux
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Visit Cytiva YouTube Library