Knowledge Center

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

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.

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

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.

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.

How media composition can maximize protein yield and quality attributes

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

PCC chromatography + straight-through processing = intensified

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 GE 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.

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 to leverage connectivity and data – maximizing efficiency from people, processes, equipment and core systems. How? By facilitating data driven decisions.

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. 

Production process using single-use bioprocessing equipment

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

For use in gene therapy and development of therapeutic vaccines

Intensify downstream processing of mAbs with innovative, integrated approaches

Productivity of chromatography processes is limited by mass transfer and surface area of existing technologies. Fiber adsorbents address these challenges and support downstream process intensification efforts.

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

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.

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?

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. E. coli and yeast were used as challenging organisms and NaOH as sanitization solution.

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

Adapting to manufacturing scale

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

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

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.

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

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.

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.

HyClone VaccineXpress cell culture medium promotes the production of infective influenza virus and rotavirus in a scalable ADCF process.

Learn how Process Characterization Kits can be used to assess the potential impact of resin ligand density variability on product quality and process performance.

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 GE discuss impacts and propose solutions for successful MES implementation