Défis et Opportunités des Nanotechnologies / Nanotechnologies: Challenges & Opportunities et à la production d'API ultra-puis- à la conjugaison et au remplissage et doivent ensuite être conjugués, avant sants, de charges utiles et de liens à la finition. Les ADC constituent une de conditionner le produit final. Une de charges utiles pour les ADC) en nouvelle classe importante de trai- complexité supplémentaire résulte de s’appuyant sur plus de 40 ans d'expé- tements oncologiques qui associent la nécessité d'effectuer quelques opé- rience dans la fabrication de produits un anticorps ciblant la tumeur à un rations dans des installations à haut cytotoxiques. Avec l'acquisition de médicament cytotoxique destructeur niveau de confinement en raison de la GTP Bioways, Olon Biotech sera en de cellules (charge utile). Leurs déve- toxicité des matériaux. mesure d'offrir des services complets loppement et fabrication constitue Leader mondial dans le développe- pour le développement et la produc- des tâches complexes : développement ment et la production d'ingrédients tion d'ADC, capable de fournir des d’un anticorps monoclonal (mAb) et pharmaceutiques actifs (API) pour AcM aux linkers, aux charges utiles, d’une charge utile cytotoxique, qui les marchés CDMO et génériques, Ligne de fabrication de produits microbiens chez GTP Bioways Production line for microbial products at GTP Bioways offering, taking care of all stages of the centres operate to the highest quality group also has significant expertise in life cycle, from R&D and preclinical standards, in accordance with reference bio-conjugation and fill & finish. The phases to industrialisation, including cGMPs, and are regularly inspected by CDMO services offered constitute an microbial and mammalian fermentation the relevant regulatory authorities. integrated platform capable of supporting and biotherapies. In addition, Olon Bio- The areas of activity on which they focus customers from drug discovery through tech will be able to provide comprehen- include biologics and ADC manufactu- the entire development process, with a sive services for the development and ring (using mammalian and microbial particular focus on preclinical, phase I production of innovative classes of ADCs, fermentation technology), nanomedicines and phase II. offering a complete solution ranging from manufacturing, filling and finishing mAbs to linkers, payloads, conjugation and analytical development - including Expansion of Olon's and filling and finishing processes. HCPs and immuno assays. The company capacity has built up solid expertise in the areas GTP Bioways' sites in which it operates. This is evidenced Each company acquired by Olon has by a significant number of successfully brought valuable expertise, strengthening GTP Bioways operates four sites in developed biological processes, the mana- its technological capabilities. This new France (Toulouse, Labege, Veyre-Monton gement of a wide and diversified range acquisition perfectly complements Olon's and Saint-Julien-en-Genevois), focusing of expression systems (mammalian, bac- existing assets to enrich and broaden on development, clinical trials and manu- terial, yeast, insect cells) and molecules the offering to its customers. In the third facturing to cGMP standards. The head (mAbs, antibody fragments, cytokines, quarter of 2024, Olon will complete office is based in Toulouse. These four fusion proteins, enzymes, antigens). The its €25 million investment in a facility 70The Pharmaceutical Post 19 / Juil let - 2024