The biotherapeutics pipeline is evolving, and so are the tools to purify and manufacture therapeutic molecules. How can you leverage these tools to streamline your process development? To find out, we gathered biopharma experts and our own Cytiva associates at Chromatography + filtration virtual summit 2024, an online event held over three days in March. Topics were wide ranging and included advances in purification and filtration for monoclonal antibodies (mAbs), antibody variants, recombinant proteins, and gene therapy. Find summaries and session recordings below.
Is your downstream process development on the right track?
- Efficient and high-yield purification of antibody-derived molecules
- Multi-attribute SPR tool for biotherapeutic characterization
- Faster, standardized recombinant protein purification
- Get filtration right the first time
- Optimize your gene therapy process
- But is it sustainable?
Platform approaches to purifying mAbs offer consistency and predictability — both in terms of effectiveness and performance. But what about other antibody-based therapies such as bispecifics (bsAb) and fragments?
Josefin Bolik (Cytiva) tackled this question with a presentation on efficient purification approaches for antibody-derived entities using MabSelect™ VH3 resin and MabSelect™ VL resin.
Ulrika Knutsson (Cytiva) presented a study of maximizing yield and purity of a bsAb through buffer optimization using MabSelect™ VL resin.
Anna Moberg (Cytiva) showed real-life examples of how using Biacore™ surface plasmon resonance (SPR) systems to characterize mAbs, variants, plasma proteins, and viral vectors can help close the gap between R&D and QC.
The novel Cytiva™ Protein Select™ technology simplifies process development for recombinant proteins that do not have an affinity binding partner — Emma Lind and Johan Öhman (Cytiva) presented comparison data.
Mike Collins (Cytiva) shared how we conducted extensive — but inexpensive — filterability trials to develop Supor™ Prime sterilizing-grade filters for high-concentration biologics.
Straightforward scaling for depth filters: 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.
Get a handle on regulatory: 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.
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 insights.
Peter Guterstam (Cytiva) introduced a new resin, Cytiva™ SuperSEC resin, a gentle yet scalable, size-based solution to purify large molecules such as exosomes.
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.
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