The biotherapeutics pipeline is evolving, and so are the tools used to manufacture therapeutic molecules. How can you leverage these tools to streamline your process development? To address this, we regularly gather biopharma experts and our Cytiva scientists at our Process development virtual summit, an online event held over three days. Topics were wide ranging and included advances cell culture, chromatography, filtration, lipid nanoparticle (LNP) manufacturing, and aseptic filling for monoclonal antibodies (mAbs), antibody variants, recombinant proteins, mRNA, pDNA, and gene therapies. Find past session recordings and summaries below.
Is your downstream process development on the right track?
Streamlined upstream process scale-up and tech transfer
Good bioreactor scaling strategies are important for both scale-up and scale-down in process development through commercial manufacturing. Get tips on how to scale cell culture seamlessly and avoid tech transfer delays.
Strategies for successfully scaling cell culture processes from PD to large scale (2025)
Andreas Castan discussed the ins and outs of scaling and how our Bioreactor Scaler tool can help you save time, accelerate development milestones, and gain confidence in the insights of your process while reducing costs.
Tech transfer of a CHO mAb process to X-platform bioreactors (2025)
Kerem Ifran showed how our Fast Trak™ process development team demonstrated the performance of our newest Xcellerex™ X-platform bioreactors, successfully replicating a mAb harvest titer of 4.4 ± 0.3 g/L for all for runs.
Advanced cell culture media analytical testing and raw material characterization
Cell culture media inconsistencies coupled with a lack of a thorough analysis program can impede upstream process development. Listen to these sessions to learn how to achieve critical quality attributes.
Unraveling the secrets of poloxamer 188 in cell culture (2025)
Christopher Woolstenhulme presented our efforts to identify the impact of Polypropylene glycol (PPG) in poloxamer 188 (P188), and the reversed-phase liquid chromatography and mass spectrometry (LC/MS) method we developed to screen for them in a single test.
Building a USP1023 trace metal monitoring program for cell culture media (2025)
USP<1023> has provided much needed guidance on trace metal control methods for cell culture media. In this session, Nathan Israelsen explained our in-house methods to test raw materials and complex media that meet and exceed requirements listed in USP<1023>.
Analytical testing for process liquids and buffers (2025)
Kennedy Mpungu presented the reasons why buffers and process liquids require testing of specific attributes and how our analytics team can help you remain compliant with US FDA regulations.
Panel discussion – cell culture analytical techniques and raw materials characterization (2025)
Nathan Israelsen, Kennedy Mpungu, Adam Allen, and Christopher Woolstenhulme explained how to identify differences in cell culture media before you buy, future challenges related to trace metals facing the industry, and how artificial intelligence (AI) and machine learning will unlock new insights and capabilities for cell culture.
Efficient and high-yield purification of antibody-derived molecules
Platform approaches to purifying monoclonal antibodies (mAbs) offer consistency and predictability — both in terms of effectiveness and performance. Learn how optimizations in mAb processes and other antibody-based therapies, such as bispecific antibodies (bsAbs) and fragments, can lead to improved process outcomes.
Intensifying the mAb capture step for cost-efficient processing (2025)
Eva Heldin evaluated various strategies for the mAb capture step, suggesting factors to consider when choosing a strategy, including productivity, cost, or process time. She also discusses opportunities presented by the recent introduction of the high-capacity MabSelect PrismA™ X protein A resins and how different protein A resins impact productivity.
Purification strategies for antibody-derived entities: bispecifics and fragments (2024)
Josefin Bolik explained how purification platforms used for mAbs need to be adopted for antibody variants to simplify protocols and improve purity and yield. She presents strategies for purifying bispecific antibodies and antibody fragments using MabSelect™ VH3 resin and MabSelect™ VL resin.
Asymmetric bispecific antibody purification platforms (2025)
Asymmetric bispecific antibodies have a great potential for becoming the next big leap for antibodies, but they present challenges for purification. Mats Ander showed how newly developed tools and a systematic approach can be used to achieve high purity of the correctly paired antibody in the capture step.
Buffer optimization for separation of bsAb in a capture step using MabSelect™ VL resin (2024)
Ulrika Knutsson presented the effects of different buffer substances, mono-, di¬, and tri-carboxylic acids, and concentrations on elution pH, resolution between hetero- and homodimers for bsAb’s, and removal of light chain from mAbs during elution when using MabSelect™ VL protein L resin.
It’s time to automate buffer preparation: Save time in process development and simply scale up for process economy (2025)
Lotta Hedkvist explained how ÄKTA™ avant chromatography system can be used to design in buffer formulations for a large-scale inline conditioning (IC) system to increase efficiency in buffer preparation and reduce footprint.
Faster, standardized recombinant protein purification
The novel Cytiva™ Protein Select™ technology simplifies process development for recombinant proteins that do not have an affinity binding partner.
Process development using a nonaffinity method vs Cytiva™ Protein Select™ resin (2024)
Emma Lind and Johan Öhman presented comparison data that demonstrates developing a full recombinant protein purification process can be two times faster when using the Cytiva Protein Select resin in the first capture step.
Panel discussion – using Cytiva Protein Select™ technology for process development and scale-up (2025)
Johan Öhman and Peter Lundbäck covered how process development can be standardized with the use of a traceless and self-cleaving tag. This shortens the overall development time while maintaining—or improving—product quality in fewer steps.
Increased process understanding with Chromatography modeling
Using modeling during process development can improve efficiency. Yet, it can be difficult to know when, where, and how to apply advanced analytics in process development. Learn how your peers are applying GoSilico™ chromatography software to accelerate downstream process development (PD) workflows with fast and reliable simulations.
DoE, mechanistic modeling, and artificial intelligence in chromatography: concept, requirements, and when to use (2025)
In this presentation, Martin Sichting discussed the benefits and considerations for process development scientists who want to apply statistical modeling (design of experiments, DoE), mechanistic modeling, or artificial intelligence (AI). He covers the fundamental principles of these different approaches, the resulting requirements to apply them, and our outlook on future use cases.
Holistic in silico process development for antibody formats (2025)
Lena Enghauser explored applications of in silico process development (PD) techniques exemplified by a bispecific antibody (bsAb) modeling workflow case study, targeting the removal of product-related impurities from the desired heterodimer during an affinity chromatography step using MabSelect™ VL protein L resin.
Future-proof your PD: What's next for in silico chromatography (2025)
Alexander Gutzler presented the key challenges that must be addressed to facilitate the democratization of modeling and enable its use across different clinical stages, including process characterization for regulatory filing.
Application of mechanistic modeling to predict impact of resin lot variabilities on cation exchange chromatography processes (2025)
Thomas Fuchs explained how we demonstrated that the colloidal particle adsorption (CPA) mechanistic model was able to accurately predict the breakthrough and elution behavior on the other resin lots in an ion exchange (IEX) chromatography process step. This result could enable development teams to rapidly adapt processes to maximize performance on each resin lot.
Get filtration right the first time and maintain performance through scale-up
While it may be a later stage decision, selecting the right filters for your downstream process is essential. The development of high concentration drugs and intensified upstream processes only add more pressure to your filtration strategy. In these sessions, we’ll discuss how we approach these challenges.
Considerations in depth filter scale up (2024)
Nick Marchand (Cytiva) talked through a scale-up study of depth-filtration capsules and modules. The takeaway is good news: capacity in bench-scale Supracap™ 50 depth filter capsules should be equivalent to that in manufacturing-scale Stax™ depth filter modules.
Optimization of SPTFF for high concentration applications (2025)
Sandeep Kristiansson presented a case study of a 50 L scale high-concentration mAb process (> 200 g/L), utilizing single-pass TFF for final concentration, including subsequent optimization to minimize protein aggregation.
Optimizing chromatography and filtration for mAb virus clearance (2025)
Mark Schofield and Nigel Jackson explained how the use of surrogate viral particles to identify optimal clearance conditions during chromatography process development allows for de-risking prior to clinical trials and new evidence that suggests we can push the boundaries of the design space in virus clearance to accommodate a broad range of process scenarios.
Virus filtration: regulations and mechanisms (2024)
Nigel Jackson walked us through regulatory changes and the detailed mechanisms governing effective virus filtration, demonstrating specific methods and advanced filter design approaches that can help overcome these challenges.
Developing a sterilizing grade filter for high concentration biologics (2024)
Mike Collins (Cytiva) shared how we conducted extensive — but inexpensive — filterability trials to develop Supor™ Prime sterilizing-grade filters for high-concentration biologics.
Optimize your processes for mRNA, pDNA, gene therapies, and other novel therapeutics
Many of the growing pains in novel therapeutic development are reminiscent of the early days of monoclonal antibodies (mAbs), when the industry struggled with low titers and poor purification yields that resulted in costly and inefficient commercial manufacturing. Listen to these talks to learn how your process development team can overcome these challenges.
pDNA optimization and scale-up to 30 L (2025)
Denis Kole discussed optimizing and scaling up a plasmid DNA process. Learn how our Fast Trak™ process development services team used design of experiments and scaled up to 30 L in an Xcellerex™ XDR-50 dual-purpose bioreactor.
Scaling new heights: Ionizable lipids for nanomedicine development, GMP manufacturing, and clinical success (2025)
Martin Rabel gave an overview of our optimized ionizable lipid and lipid nanoparticle (LNP) composition that streamlines RNA delivery in nanomedicines, facilitating payload screening and LNP optimization. He also shares details of our collaboration with Replicate Bioscience that resulted in a self-replicating RNA (srRNA) vaccine with promising Phase 1 clinical data, showcasing a favorable safety profile and promising immune protection for a novel RNA-based vaccine.
In silico optimization of AAV full/empty particle separation with AIEX (2024)
Lena Enghauser (Cytiva) presented a workflow for in silico process optimization of AAV full/empty separation with the GoSilico™ Chromatography Modeling Software, showcasing how a process model can generate process valuable insights.
Exosome purification meeting manufacturing demands (2024)
Peter Guterstam (Cytiva) introduced a new resin, Cytiva™ SuperSEC resin, a gentle yet scalable, size-based solution to purify large molecules such as exosomes.
Downstream viral vectors – Supor™ Prime sterile filtration for AAV (2025)
Stijn De Backer explained how Supor™ Prime filters can help you meet cGMP regulations when used at various stages of AAV manufacturing, including media, harvest, and final sterilization.
Leverage multi-attribute SPR tool for biotherapeutic characterization
Learn how our Biacore™ surface plasmon resonance (SPR) systems can be used for active concentration measurement, target binding, and assessment of drug potency (EC50) and stability.
Address the complexity of protein characterization (2024)
Anna Moberg (Cytiva) showed real-life examples of how using Biacore™ surface plasmon resonance (SPR) systems to characterize mAbs, antibody variants, plasma proteins, and viral vectors can help close the gap between R&D and QC.
Protect product stability, sterility, and readiness for patient use in the “last mile”
All your efforts are finally coming to a successful culmination, and now you need to quickly move into clinical trials. How do you achieve that last, but crucial, manufacturing step of aseptic filling, meeting project timelines, staying within budget, and ensuring the utmost safety for patients?
It’s not too early to think about aseptic filling (2025)
Pratibha Yadav discussed how this can be achieved and why fully closed, gloveless isolators are the new industry standard.
Measure the sustainability of your process
Organizations all over the world have embraced sustainability and started to allocate attention and resources to sustainability development programs. How do we assess the environmental impact of our drug development processes?
Life cycle assessment of the protein A process in mAb manufacturing (2024)
Anna Grönberg (Cytiva) provided her experiences of performing a life-cycle assessment (LCA) for a protein A chromatography capture step. This is an important tool for systematically assessing the environmental impact of a component or process.