Knowledge Center

4 key considerations when finding the right CDMO for your outsourced process development needs.

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

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

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.

As bioprocesses continue to intensify, efficient design and predictable scalability of equipment are key to reaching milestones on time. Here we share a process for accelerated design and scale-up testing for a next-generation bioreactor.

A successful tech transfer is possible only with effective communication, diligent project management, and a wide range of technical and regulatory expertise.

Using mechanistic modeling to speed up the purification process development of virus-like particles (VLPs).

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

To create a complete chromatography model the adsorption of components within the adsorber beads needs to be considered. In this article we will discuss several of the most commonly used models for adsorption of proteins within a chromatography column.

Select the right air filtration solution from scalable formats for applications including stainless steel, high-temperature, highly oxidizing, and single-use operations.

Having accurate flow is important for your chromatography systems to ensure you have reproducible results at different scales and when forming a gradient. We evaluated the gradient accuracy and range for different size ÄKTA process™ systems.

How the different binding sites of protein A are affected by extensive NaOH cleaning cycles

We perform a benchmarking study to compare the resin lifetime of MabSelect™ Prisma with other popular protein A resins.

Amgen discusses how the SA25 aseptic filling workcell could help meet business needs in high-mix, low-volume manufacturing.

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.

Discover innovative analytical techniques for precision control of trace impurities in raw materials when manufacturing chemically defined cell culture media.

Process equipment-related leachables are mapped over a complete single-use mAb process at pilot scale.

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

Interview with two industry experts about the benefits of early adoption of automation in bioprocess manufacturing.

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

Products with Bioclear™ 11 film are identical to Bioclear™ 10 products except for a lower TBPP content, show a greater ability to support TBPP-sensitive CHO cells, and can easily replace Bioclear™ 10 products.

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?

Though talent is vital to all industries it is particularly so for pharma and biopharma, making a shallow pool of local talent a real issue.

Of all the lessons for Big Pharma from the Covid-19 pandemic, there is one that is likely to endure: collaboration.

In combination with artificial intelligence, augmented reality, robotics, and digital twins, biopharma 4.0 changes legacy concepts from the ground up.

Importance of aeration and ways to control kLa during cell cultivation

Bioreactor scale up and scale down are important but can be complex. Simplify with Cytiva’s web-based bioreactor scaling tool. View several case studies.

Why update your chromatography resins? To increase dynamic binding capacity, use less resin, and ease tech transfer for future biomanufacturing.

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.

How biopharma organizations can apply innovative, new approaches for talent sourcing and to fill specialized-skills gaps to grow biomanufacturing resilience

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.

Protein L resins is an alternative to protein A, for capture of antibody Fabs, bispecific antibodies, and other molecules containing kappa variants of the variable light (VL) chain. Here we present data using an alkaline-tolerant, high-capacity resin.

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.

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.

Information applicable to use of single-use bioreactors in cell culture applications.

Here we answer some common questions about our cell culture media manufacturing sites around the world ― in Pasching, Austria; Tuas, Singapore; and Logan, Utah in the United States.

How media composition can maximize protein yield and quality attributes

Using common cleaning agents including ethanol/isopropanol and hydrogen peroxide/peracetic acid for effective cleaning

We will describe the cleaning procedure of ÄKTA process™ systems connected with inline dilution (ILD) units after challenging with a mixture of two microbial organisms.

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.

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

The certification covers emergency response, crisis management, and business continuity capabilities.

By in-sourcing manufacturing of our HyClone single-use bags for liquid cell culture products at the Cytiva cell culture center of excellence in Logan, Utah, we aim to reduce lead times of these essential products to better serve our customers.

Establishing an appropriate small-scale model allows for higher throughput during operation at process conditions.

We calculated the power numbers for Xcellerex™ magnetic mixer in 2000 and 3000 L mixing tanks.

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

The success of a single-use system depends on the components’ functionality, availability, and security of supply. We saw an opportunity to better support customers in all three with Fortem™ film for bioprocessing

In this article we focus on the development of a flow-through (FT) polishing step using hydrophobic interaction chromatography (HIC) to remove mAb aggregates.

Using ÄKTA readyflux™ XL tangential flow filtration system and T-series Centrasette™ cassettes and Omega™ PES membranes for large-scale concentration and diafiltration.

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

Development of HEK293 transfection media prototype for transient protein expression and gene therapy applications

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.

Classical media are often used to grow reference cell lines for life science research. Discover the options for direct adaptation of common adherent cell lines.

Frequently asked questions about the use and performance of filter cartridges and capsules in air, gas, vent, microbial control, and particulate filtration.

Covid-19 changed the vaccine manufacturing landscape.

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.

Mechanistic process models can be applied in all stages of PC/PV from process design space development up to linkage studies

Discover how integrated automation strategies in single-use biomanufacturing can help you improve facility operations, data capture, and product quality.

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

Determining the DBC of Fibro PrismA for your molecule is a key step in your process. Learn how and why in this article.

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.

We evaluate the performance of integrated inline dilution technology on the ÄKTA process™ chromatography system, and assess process economy factors — including cost, labor, time, and space requirements — versus manual buffer preparation .

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.

Emergent BioSolutions selects Cytiva’s SA25 aseptic filling workcell, supporting their requirements for product quality, sterility assurance, and flexibility.

When using mechanistic models, is it better to develop expertise in-house or outsource?

Using orthogonal technologies to inactivate and/or remove viruses can help ensure the viral safety of your final drug product.

This study explores an alternative approach to cell line development which is more robust and increases the chance of delivering highly productive clones.

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.

Explore how downstream process development methods have evolved from DoE, HTPD, and platform knowledge, to mechanistic modeling.

Regulations for extractables and leachables in single-use bioprocessing materials frequently change.

With questions covering a range of topics from principles to protocols, we’ve heard from scientists who are interested in learning more about Cytiva™ Protein Select™ technology. Their questions and our answers are collected here — scroll through them and you might find the answers you need.

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.

Evaluation of Fibro PrismA for scalable single-use mAb purification

Performance of sterilizing grade filters in drug formulations for subcutaneous injection: A throughput benchmarking study with Supor® Prime membrane

How to efficiently concentrate a low-titer antibody sample

Novel filtration methods in bioprocessing to overcome new challenges in viral safety

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.

Information applicable to use of single-use technologies for biotechnology and pharmaceutical applications.

Protect the integrity of biocontainer bags from mechanical damage due to manual handling and minimize product loss due to uncontrolled freezing.

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

Discover how to establish a host cell line with your desired growth characteristics that can also seamlessly switch between cloning and production media.

Use this quick guide as a starting point for monoclonal antibody purification using MabSelect™ PrismA protein A resin. These tips are suitable for most mAbs and many mAb-derived molecules.

Drug shortages are common, especially in the face of unpredictable and fluctuating demand. The Global Biopharma Resilience Index points to critical local and global supply chain challenges.

How to ensure accurate model calibration for your mechanistic models.

From the basics to the typical challenges and how to overcome them.

Cytiva aims to ensure security of supply of our chromatography resins. Learn more about the complex resin production process in this article.

A review and best practice guide for customer forecasting and the role it plays in ensuring security of supply in biopharma

While the COVID-19 pandemic shone a light on mRNA, scientists have been working for decades to see how it might help fight disease. Today, researchers are working on treatments for genetic diseases like cystic fibrosis, or liver and muscular diseases.

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

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.

We explain the best practices to help you efficiently pack Capto™ HIC resins in our large-scale AxiChrom™ chromatography columns

Packing guidance for successful packing of Axichrom™, BPG, and Chromaflow™ columns

Characterized FBS from US, NZ, and AUS show comparable performance and low variability.

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.

Read these biomanufacturing insights to understand how industry collaborations and strategies can help improve biomanufacturing resilience in an unpredictable but promising future.

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

How do you build quality into a hollow fiber cartridge? Make sure you have quantitative information on the pore structure of the hollow fiber membrane. Cytiva uses a method called capillary flow porometry to do just that.

Mechanistic modeling can be used to support several activities in biopharmaceutical production, including process transfer activities, in silico troubleshooting, process analytical technologies, and automated biomanufacturing.

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. 

Frequently asked questions about filter integrity testing using Palltronic™ instrumentation.

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

In this article we compare conventional seed train methods to the use of a high-cell density cryobags. We show that high-density cryobags can be used to seed a bioreactor at a 500-fold higher seed density, reducing total process time by up to nine days.

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

Using GoSilico™ Chromatography Modeling Software it is easy to manage and share the growing process knowledge within a team throughout the product lifecycle.

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

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.

To deliver life-saving drugs more quickly, biopharma must work in harmony with governments and regulators.

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.

Many firms have taken a lead on manufacturing changes already, including Samsung Biologics and Amgen. We sit down with each of them to find out how they have achieved manufacturing agility, and what lessons the wider industry can take away.

For use in gene therapy and development of therapeutic vaccines

Possible strategies using digital twins of downstream processes.

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

Learn on the differences between statistical and mechanistic models, and their use in improving your process development.

We evaluated the mixing performance of the 3000 L Xcellerex™ magnetic mixer system for preparation of aqueous solutions.

Frequently asked questions regarding the use of membrane chromatography equipment.

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.

High-density N-1 perfusion allows 10-fold higher seed density in the final production cell culture.

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

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

The growing complexity of peptide and protein therapeutics brings unique challenges and the need for refined processes and technologies to develop and produce them. Learn more about solutions for bispecific antibodies and antibody-drug conjugates.

Nucleic acid therapeutics are offering researchers exciting new avenues of treatment. Learn what steps can be taken to minimize environmental impact while manufacturing and distributing these therapies.

How to develop a purification workflow for a protein expressed in E. coli using HIC.

Downstream processing of a bispecific antibody cancer therapeutic using antibody purification chromatography in two steps.

Innovative technology for chromatography process scale-up.

Verified column packing methods for MabSelect PrismA chromatography resin.

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.

mRNA vaccines took center stage in 2020 as the world’s best chance at beating back the COVID-19 pandemic. But to realize the full therapeutic potential of mRNA, we must address challenges in process development.

Mechanistic models are based on physical and biochemical effects and allow the examination of positive or negative effects on the process before they occur in production.

After comparing resin performance for mAb, Fab, and dAb samples, MabSelect™ VL protein L resin offered increased binding capacities versus other resins. This improvement could address existing protein L resin limitations in biomanufacturing processes.

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.

Learn how to use consolidated data from our advanced central management system for single - use system component selection

In this study, we compare platform cell culture media with clone - specific media and assess the quantitative difference in their performance.

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

How a protein A affinity resin was safely sanitized while preserving high mAb yield and purification performance.

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…

How to effectively scale up E. coli growth, plasmid titer, and percentage of supercoiled plasmid DNA up to production scale in fermentors.

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

Evaluation of Fibro rapid cycling chromatography for its performance and scalability for downstream chromatography mAb processes.

See how to apply a mechanistic model to scale-up and scale-down your chromatography process.

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.

As the past year has shown, the ability to be both malleable and swift are powerful assets in the face of virulent diseases.

This workflow improved titers 500% compared with CHO cell culture in basal medium.

Mechanistic modeling of chromatography is not just applicable for mAbs. It also applies to bispecific antibodies, ADC, peptides and more.

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.

We develop a method for sanitization of Capto™ mixed-mode resins using 1 M sodium hydroxide (NaOH) as sanitization agent.

Exposure to a wide range of temperatures and storage durations does not affect performance of fetal bovine serum for various cell lines

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.

Cytiva is focused on maintaining supply chain security through multi-site manufacturing. Learn more about resilient manufacturing for single-use technologies and beyond.

Using membrane devices, hardware, and systems for tangential flow filtration (TFF).

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.

In a conversation with Adrian van den Hoven, director general of Medicines for Europe, which represents the generic and biosimilars industries, we find out how supply chain challenges are playing out in biopharma vs generics, and what industry leaders expect to change in the future.

We speak to senior leaders at pharma giant Amgen and biotech powerhouse Samsung Biologics to find out more about talent risk and to hear what they are doing to secure the best workers.

GoSilico™ Chromatography modeling Software has introduced an adsorption isotherm class that is based on a colloidal description of proteins, which achieves increased accuracy at high column loading in IEX modeling.

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.

The pandemic changed how biopharma manufacturing companies manage security of supply. Find out how Cytiva is addressing the challenges—and what lessons the wider biopharma industry can take forward.

Managing raw material supply and variation is a critical challenge in bioprocessing. This article addresses the three key areas of supply chain transparency, consistency, and risk.

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

Achieve high purity of supercoiled plasmid DNA in this three-step process. Shows data for scale-up to pilot scale.

Evaluating the performance of TFF cassettes with 100 kDa molecular weight cutoff membranes for effective tangential flow filtration of RNA and LNPs

How will multi-product manufacturing facilities, single-use technologies, continuous manufacturing and industry 4.0 impact automation in the life science industry?

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).

Considerations for improving outcome in biopharmaceutical process development

Effective Fab fragment purification with ÄKTA go™ chromatography system and MabSelect™ affinity chromatography resins

Manage variability through advanced analytical methods and risk-based assessment

Process efficiency isn’t just about what your equipment can do – it’s also about how well it performs. Failed steps, such as leaks, in a large-scale bioprocess are costly in terms of material loss and downtime. Learn about common causes here.

See how fluid flow effects within a chromatography column are used by mechanistic models

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.

Frost & Sullivan recently invited industry thought leaders working in the viral vector manufacturing space to participate in our Virtual Think Tank (VTT), a unique thought leadership platform that brings together leading minds, to discuss viral vector manufacturing facility design.

Using core bead technology to fine tune impurity removal and maximize recovery of large entities

Creating a predictive model of your downstream process using mechanistic chromatography models based on natural science.

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

WuXi Biologics moves from purchase order to GMP batch release in 15 months, with 7 vial, syringe, and cartridge formats validated.

Process we developed produced 179 MVC/mL in a 50 L bioreactor.

Calculators and converters for tangential and normal flow filtration

Save time optimizing your cell culture as you scale up or down in the Xcellerex XDR platform

Calculators, converters, and selection guides for chromatography

Browse our free eLearning courses and grow your skills

Discover the right intensification strategy for your process by entering your upstream and downstream process parameters

Principles and methodology handbooks covering bioprocess techniques and applications