GTP Bioways Group is a French company operating as Biotech CDMO (Contract Developing and Manufacturing Organisation), specialising in R&D Services, process development and production of mAbs, enzymes, proteins, nanodrugs, ADCs and F&F. GTP Bioways Group, with multiple locations across France, specializes in delivering comprehensive services to biopharmaceutical companies. From preclinical development to commercial stages, the group focuses on utilizing cutting-edge technologies to advance innovative therapies. GTP Bioways Group’s services are seamlessly integrated with those of the Olon Biotech division. This integration enables Olon Biotech to expand and diversify its technological offerings, supporting every stage of the lifecycle, from R&D and preclinical phases to industrialization, through microbial and mammalian fermentation and biotherapeutics. Additionally, Olon Biotech will provide comprehensive services for the development and production of innovative ADC classes, offering a complete solution from mAbs to linkers, payloads, conjugation, and fill-and-finish processes.
GTP BIOWAYS
GTP Bioways operates a total of four sites in France (Toulouse, Labege, Veyre-Monton, and Saint-Julien-en-Genevois) focused ondevelopment, clinical trial andcGMPmanufacturing. The headquarters are based in Toulouse.
The four centers operate according to the highest quality standards, in line with reference GMPs and are regularly inspected by the relevant regulatory authorities.
The business areas on which GTP Bioways focuses include biologics manufacturing and ADC manufacturing (using mammalian and microbial fermentation technology), nanodrug manufacturing, fill and finish and analytical development – including HCP and immuno assay. In particular, the company has consolidated a strong expertise in the business areas in which it operates. Evidenced by a significative number of successfully developed biological processes, the management of a broad and diversified range of expression systems (mammalian, bacterial, yeast, insect cells) and molecules (mAbs, antibody fragments, cytokines, fusion proteins, enzymes, antigens). In addition, the group possesses significant expertise in bioconjugation and fill & finish. The CDMO services offered make up an integrated platform capable of supporting customers from drug discovery, through the entire development process with a special focus on the pre-clinical phase, phase I and phase II.
OLON STRATEGY AND EXPANSION OF CAPACITY
Since its foundation, Olon Group has consistently pursued a strategy of growth, consolidation, and global market expansion through both internal development and strategic acquisitions. Each acquired business has contributed valuable expertise, enhancing Olon’s technological capabilities. In line with this strategy and aiming to advance its innovative and high-tech offerings to customers, Olon has acquired GTP Bioways Group. GTP Bioways Group’s specific capabilities in fully supporting CDMO biotechnology projects also in the early phase of new molecule development (pre-clinical, phase I and phase II), perfectly complements Olon’s current assets, to enrich and broaden the offering to customers.
“The acquisition of GTP Bioways Group implies a strong and significant strengthening of Olon’s service pipeline with the aim of creating new business opportunities, acquiring new customers and high-potential market areas, and ultimately continuing the company’s growth” stated; Paolo Tubertini, CEO Olon Group.
In Q3 2024, Olon will finalise its €25m investment in a facility operating under extremely high containment, fully dedicated to the development and the production of Ultra High Potent API – payloads and payload-linkers for antibody-drug conjugates (ADCs). Olon relies on more than four decades of experience in manufacturing cytotoxic products. With the acquisition of GTP Bioways, Olon Biotech will be able to offer full services for the development and production of ADCs, capable of supplying everything from mAbs to linkers, payloads, conjugation and fill and finish.
“ADC class is highly promising and extremely challenging as well, as they require specific capabilities to handle different modalities with strict containment regulations. This required high level of control ensures the safest environment for ADC payload-linker production and product integrity, that canonly be reachedleveragingoverdecades of expertisein containment for cytotoxic anticancer production, focusing on full control of cross-contamination, operator protection and extensive training” commented Paolo Tubertini.
Antibody–drug conjugates (ADCs) are an important new class of oncology therapeutics that combine a tumor-targeting antibody with a cell-killing cytotoxic drug (payload). The development and manufacture of an ADC are complex tasks, with the requirement for both a monoclonal antibody (mAb) and a cytotoxic payload, which then need to be conjugated, after which the final product must be fill-finished. Additional complexity results from the need to perform a few operations in high-containment facilities because of the toxicity of the materials.
Olon Group is a global leader in the development and production of active pharmaceutical ingredients (APIs) for CDMO and gene ric markets, integrating chemical synthesis and biological processes while always embracing the highest international safety, quali ty, and environmental standards. With one of the longest track records of the API industry, having deep development expertise and a broad set of advanced technologies, we are the partner of choice which enables our client’s molecules to enter the market successfully. Olon has a global network of 11 manufacturing sites and 7 R&D centers across the globe. Thanks to our 2,300 employees, including 300 highly experienced and qualified R&D experts, we represent a highly innovative and reliable partner. At Olon, expertise and competent flexibility throughout the organization help build successful outcomes for our clients in custom chemical synthesis and microbial fermentation, while always maintaining the highest levels of safet y, quality, and environmental compliance.
Olon Biotech is a division of Olon Group. This cross-functional division embraces and relies on functional support and expertise from all the corporate functions: R&D, M&S, Operations, Procurement, Regulatory and Quality. Olon Biotech offers Contract Deve lopment and Manufacturing Services (CDMO), as well as developing, manufacturing and selling Proprietary Products (PP)
