Biologics In Focus - May 2025
Welcome to the May edition of “Biologics In Focus”, Lonza’s monthly newsletter dedicated to the biologics industry.
In this issue, we’re thrilled to highlight the launch of our new GSquad® Pro vector system, a breakthrough in biologic protein manufacturing. This system, featuring our novel LHP-1 gene promoter, can support the efficient production of a wide range of molecular formats, including bispecific antibodies and fusion proteins. We dive into scientific content on how this novel system works, in addition to the importance and methods of immunogenicity risk mitigation early in biologics development, and Roche’s U.S. expansion - read on for insights and industry updates that shape the future of biologics.
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News and updates
Earlier this month, we announced the launch of our enhanced GS Gene Expression System® vector technology, GSquad® Pro. Designed to boost titers while delivering excellent stability and product quality, this vector system supports the efficient production of biologics, including monoclonal antibodies, bispecific antibodies and fusion proteins. Integrating seamlessly with our Integrated Biologics services offerings, our advanced expression technologies can streamline development from all the way from discovery to commercial manufacturing.
Insights and analysis
Novel synthetic fusion promoter for improved GS-CHO expression of biotherapeutics
Read this technical note to discover why and how we’ve prioritized advancing our vector technology by developing the LHP-1 synthetic promoter. In addition, it can boost titers and product quality while delivering excellent expression stability for numerous molecule types, addressing key challenges in biomanufacturing.
The importance of assessing and mitigating immunogenicity potential
In light of the FDA's recent announcement to phase out animal testing requirements for mAbs and related molecule types in preclinical safety studies and replace with alternatives such as human-based in vitro assays, we emphasize the importance of early immunogenicity assessment for a successful IND submission and how Lonza can support. Our e-book explores strategies to evaluate and mitigate immunogenicity risks using in silico and in vitro methods, aligning with evolving regulatory guidance and enhancing the safety and efficacy of biotherapeutic development.
Lonza in the press
Roche looks to expand its drug production in the US
Roche is expanding its drug manufacturing footprint in the U.S. to support the production of next-generation therapies. This strategic investment reflects a broader industry trend toward strengthening domestic pharmaceutical capabilities. The expansion follows previous moves within the sector, such as Roche’s sale of its Vacaville biologics site to Lonza, highlighting shifts in global manufacturing priorities.
Upcoming events
Upcoming webinar
Monday, 9 June 2025. 11am EDT | 8am PDT | 5pm CEST
Given the increasing prevalence of advanced, more complex biologics, a strategic and integrated approach to candidate selection, preclinical evaluation, and manufacturing readiness is essential. Join us to explore how leveraging the right technologies and strategies early in development can help to optimize candidate selection, aid progression to cell line development, enhance manufacturability, and reduce downstream risk.
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Key Account Sales Manager at North American Drone
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Board Advisor @ BioPharmaTrend.com | AI and HPC consulting
6dAndrii Buvailo, Ph.D.
Associate Director Licensing at Lonza
1wGreat to see the launch of the new synthetic fusion promoter for protein expression. Increasing yield and strengthening stability are key in optimizing manufacturing processes of protein based therapeutics.
Process and product development expert with commercialization expertise. Passionate about evaluating technologies and bringing products to market while optimizing operational processes to maximize profits.
1wSome great additions to the Lonza platform technologies
Licensing expert @Lonza.If you are expressing a protein or antibody therapeutic or AAV gene therapy I can help. Please contact me and lets chat about getting your therapy to patients.
1wExciting things happening at Lonza that can help you accelerate your therapies to the market.