Glycotope's GlycoExpress Glyco-Optimization Platform Reaches Clinically Validated Superior Quality and Unmet Production Yields of ADCC-Improved Antibodies
Glycotope updates on its proprietary GlycoExpress (GEX) platform for superior quality as well as superior yield for low production costs of ADCC-(antibody-dependent cell-mediated cytotoxicity)-improved monoclonal antibodies.
Glycotope's GEXplatform comprises a comprehensive portfolio of proprietary glyco-engineered human suspension cell lines, which allow for the production of proteins with tailored glycosylation patterns. With the combined advantages of optimized sialylation, galactosylation, fucosylation, branching and lack of non-human sugar structures, GEX products deliver improved bioactivity, stability, serum half-life and immunogenicity of biopharmaceuticals.
GEX today is the only platform that provides the opportunity to combine several features to maximize ADCC activity of fully human glyco-optimized monoclonal antibodies. By combination of minimizing fucosylation, maximizing galactosylation and branching, the ADCC activity can be maximally increased. This together with the unmet production yields and the superior reproducibility makes Glycotope's GEX the most potent platform for ADCC improvement.
CetuGEX and TrasGEX, two best-in-class molecules targeting EGFR and Her2, respectively, were tested in Phase I/IIa clinical trials with patients who failed standard therapies. Strong clinical benefit and responses were observed in patients in whom therapies with non-glyco-optimized antibodies had already failed. Clinical benefit was observed in both, typical and non-typical indications of the non-glyco-optimized antibodies. All these observations clearly demonstrate the advantages of glyco-optimization for cancer therapies when using the GlycoExpress technology.
Glycotope has demonstrated with three different antibodies in advanced stage clinical development that cost efficient production with unmet quality is achieved through a proprietary perfusion process with outstanding productivity of 10–20 g/L bioreactor volume and up to 0.8 g/L per day. To date, more than 40 GMP production runs have been performed, showing unique reproducibility with no measurable differences between batches, batch sizes, process strategies, scales and production sites, all of which guarantees flexible production.
The GEX platform is approved by several regulatory authorities for clinical use (including EMA, FDA).
Related News
-
News Pharmapack Awards 2024 Patient-Centric Design Award Winner – Dr Ferrer BioPharma
The 2024 Pharmapack Awards celebrated the best in innovation and design for the pharmaceutical packaging and drug delivery industry on January 24, 2024. -
News Women in Pharma: Minding the Gap at Pharmapack 2024
2024 marks the first year Pharmapack will host a Diversity track dedicated to bridging the gap within the pharmaceutical packaging and drug delivery sector. The track includes a panel discussion on 'Enabling Diversity in the Workplace,' focused... -
News Pharmapack Awards 2024 - Celebrating Packaging and Drug Delivery Innovation
The 2024 Pharmapack Innovation Awards ceremony celebrated the best in pharmaceutical packaging and drug delivery innovation at all levels. The awards were held on January 24, 2024 at the Paris Expo Porte de Versailles. -
News 2024 Pharma Industry Trends Outlook: Collaboration, Market Maturity, and Digital Futures
The annual CPHI Online 2024 Pharma Trends Outlook, in partnership with Arvato Systems, identifies 12 key industry trends shaping the life sciences industry in the coming year. -
News New Novo Nordisk AI hub for drug discovery to open in London, UK
Danish pharmaceutical giant Novo Nordisk will be opening an AI-based research facility in the heart of London to advance drug discovery operations. -
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Women in Pharma: Looking back on 2023 and moving forward to 2024
In this monthly series, we interview women from across the pharmaceutical industry and supply chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. -
News CPHI Barcelona 2023: Partnering for Success – Managing Outsourcing Relationships to Optimise Manufacturing Operations
During CPHI Barcelona 2023, insightful content sessions offered attendees the chance to explore trending topics with expert speakers and panellists. Here, we summarise what the pharma industry and supply chain are talking about the most.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance