Knowledge Center

Meeting the process development challenges of a diverse biologic pipeline How to navigate the evolving biopharmaceutical landscape from a process development standpoint.

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

See what simple habits can have an outsized impact on the reliability and longevity of your lab equipment.

Small-scale model for a monoclonal antibody (mAb) cell culture perfusion.

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

This case study highlights how our Fast Trak Services team to help accelerate process development for cGMP production of material for toxicology studies.

Improving bioprocess efficiency is key to succeeding in a fragmented market. Use the latest technologies and solutions to do it without sacrificing flexibility.

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.

Fortem™ single-use bioprocessing film technology: cell growth, carbon dioxide and oxygen transmission rates, flex fatigue, and other analyses.

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.

Purification platform for vaccine production

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.

Addressing microbial contamination

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.

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?

Importance of aeration and ways to control kLa during cell cultivation

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.

Learn ways to resolve bottlenecks in the manufacturing process caused by buffer preparation.

Choosing the right partner is key to addressing the challenges of implementing single-use technology.

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.

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.

This case study describes a successful viral clearance study for a protein A chromatography biomanufacturing step.

How media composition can maximize protein yield and quality attributes

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.

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.

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.

Intensify your process by going from cell vial to 2000 L bioreactor in 1 step

Data connectivity and comprehensive automation ease bioprocess tech transfer and scaling from process development to final manufacturing scale.

Learn about how a continuous automated process can save significant time and effort while maintaining product quality.

PCC chromatography + straight-through processing = intensified

Explore a developed closed connected downstream purification process and learn how new technologies can provide improvements

Key milestones and planning ahead for compliance when bringing a new biologic drug to market.

Digital technologies can improve productivity and growth in cell therapy manufacturing and in bioprocessing.

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.

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.

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.

Study compares powdered cell culture medium production using Sturtevant and Hosokawa pin mills. Physical, chemical, and biological data including cell growth.

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.

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.

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

Buy vs build: what is the best strategy to establish and maintain efficient and productive manufacturing operations? Here is what ArmaGen decided to do.

Which offers better process economy and production capacity: single-use or stainless?

Study evaluates research-scale units and 96-well plates in applications for high-throughput monoclonal antibody purification.

How to efficiently concentrate a low-titer antibody sample

Accelerate production with modern tools and solutions

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.

Learn how fellow scientists use ÄKTA avant to gain efficiency in protein purification process development

Digitalization means a more productive and adaptive plant through the application of analytics…

We have sucessfully conducted a large-scale scale perfusion run using Xcellerex APS connected to an Xcellerex XDR 50 bioreactor.

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.

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.

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.

Production process using single-use bioprocessing equipment

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. 

Explore downstream operations to improve biomanufacturing productivity, speed, and flexibility. Options include improved resins, prepacked columns, continuous chromatography operations, and fiber-based chromatography.

Up-front design considerations can improve your long-term processing flexibility and ability to expand

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.

For use in gene therapy and development of therapeutic vaccines

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.

This article explores the opportunities and challenges with using mechanistic modeling for chromatography.

Intensify downstream processing of mAbs with innovative, integrated approaches

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.

Explore available options to select a path based on molecule and facility needs

Innovative technology for chromatography process scale-up.

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.

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.

New market dynamics are reshaping how biologics are produced and sold. Here’s what six industry experts say about the way forward.

Considerations for aligning design space for multiple connected single-use processes to ensure operational flexibility and efficiency resulting in a high quality product.

Collaborative Development of a Next-Generation Chromatography Resin for the Purification of Plasmid DNA

Biomanufacturing requires a film technology specifically designed for working with biologics.

The importance of resin variability characterization for obtaining robust chromatography polishing processes

Accurate determination for optimal column performance

How do you identify which parameters and interactions to focus on in your process characterization studies?

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.

Peracetic acid (PAA) was evaluated as sanitization agent in the packing and repacking of a protein A resin in AxiChrom 300 column.

In this study we evaluated the predefined sanitization methods for the ÄKTA pilot 600 chromatography system.

HyClone VaccineXpress cell culture medium promotes the production of inflective influenza…

Moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform

Transparency across the single-use film supply chain helps to ensure security of supply for single-use bags.

Compared to just a decade ago, managing the biopharmaceutical supply chain has become a far more complex topic.

Adapting to manufacturing scale

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.

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.

Learn how variability of resin ligand density may impact product quality and process performance.

From platform processes to disruptive technologies: The future of innovation continues.

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.

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.

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.

Guidelines for developing immunoassay reagents using technolgies such as Biacore surface plasmon resonance

Considerations for improving outcome in biopharmaceutical process development

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).

Manage variability through advanced analytical methods and risk-based assessment

This paper exemplifies how to use available and reliable sensors for in-process control of several different upstream and downstream process parameters.

Accelerate cell-based vaccine production with modern tools and solutions

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?

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.

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

Calculators and converters for tangential and normal flow filtration

Calculators, converters, and selection guides for chromatography

Principles and methodology handbooks covering bioprocess techniques and applications

Automation in process development and biomanufacturing

Sustainable supply and risk management programs: challenges and considerations

Shire and Cytiva discuss impacts and propose solutions for successful MES implementation

A systematic approach to identifying and solving cell culture media challenges earlier in your bioprocess workflow.