Taking advantage of the multisite footprint and a large technological portfolio available, Olon can be considered a real one-stop shop supporting all the phases of the development of a new drug starting from preclinical material up to the product required for the launch and commercial. In addition, we represent a one-stop shop from operational standpoint since that we can be involved in the production of an API starting from basic raw materials through regulatory starting materials, GMP-intermediates to the final API.
We constantly invest in our sites to upgrade the facilities in terms of GMP and technology standard, and to increase the manufacturing capacity.
We are working on the cutting edge of R&D applied both to chemistry, with flow chemistry, photochemistry and electrochemistry, and to biotechnologies
High-level expertise and know-how applied to specific processes, consolidated in the 11 Olon plants worldwide and 7 research centres, are connected, shared, and extensively applied across the whole of the group’s manufacturing network.
We offer seamless transition of the technology and scale-up, advanced control and in-depth understanding of out customers’ processes from the outset, engaging the best in-house talent specialised in the specific process or technology.
The constant investment in innovation is strictly integrated with the protection of intellectual and technological property, in which the company invests heavily, and which represents a strategic asset of the Group.
The management and protection of proprietary know-how takes place according to consolidated company policies that regulate confidential information, including those owned by third parties.
As regards Olon’s patent portfolio, it currently includes approximately 65 patent families, equal to approximately 256 patents, between patent applications and granted patents.
For the protection of the research and innovation generated in Olon, the IP function is committed to identifying and protecting them, including through either the filing of patent applications for Olon owned IP or the support to our customers for the filing of their patent application.
Olon guarantees that each product and related synthesis processes do not violate the IP rights of third parties. This occurs through constant and continuous work of analysis, evaluation and updating of the opinions developed.
Next level technology
Advanced High Containment / Payloads (ADC)
Thanks to recent investments in its integrated manufacturing network, today Olon offers the capacity to develop and produce highly potent APIs, from very small to large scale, along the entire development chain.
This is because Olon relies on all types of reactors regardless of required size, as well as its experience in managing high containment production processes which is among the most extensive worldwide.
We have completed the new extremely high containment production line with reactors that allow us to produce highly potent APIs in large-scale product batches ranging from 30 to 150 kg. This expansion enables us to serve the customer along all the stages of the scale up, in conjunction with our sites.
We are building a new facility which will be entirely dedicated to managing and producing Ultra-Potent compounds, used for example as payloads and payload-linkers for antibody-drug conjugates. The ultra-high-containment production line will produce high-potency and toxic products and will therefore reach containment level OEB6 (target OEL 10 ng/m3).
Today we are one of the few API suppliers to offer the range of of specific integrated capabilities necessary to support the customer from the first clinical phase up to industrialization, regardless of the quantity of product needed and batch size required and regardless of the ongoing molecule development phase. From a few grams to hundreds of kilograms.
The expertise in high containment processes is evident from the equipment we have at our disposal, but even more so from the in-house know-how that we have developed in recent decades, among the most extensive in the global API manufacturing market.
Biomanufacturing
With more than 50 years experience in microbial fermentation, Olon has developed extensive know how which it applies to both CDMO and Proprietary Product production, including High Potent or Toxic Compounds requiring high containment systems. Our experience in microbial fermentation embraces a broad range of bacteria, yeast and fungi. We offer a wide range of expertise from small molecules to large molecules – peptides, enzymes, proteins. We are an industry leader in applied biotechnology at industrial scale, able to manage the complexities often associated with the technical transfer and scale up stages. We are supported by a strong team experienced in developing production processes from pilot to commercial scale. Due to our wide range of fermenter sizes (from 1 to 5, from 35 to 60 from 112 to 255 metric cubes) we offer a total fermentation capacity 4,900m3 , making Olon Biotech one of the largest companies providing manufacturing services for third parties via microbial fermentation in Europe. We have a customer focused approach enabling us to develop a project plan that meets both the process and timeline requirements.
Technical & Analytical Capabilities
One of the widest range of leading-edge technologies chemistry and biotechnology expertise.
- High Potent Compound handling capabilities
- Filter driers, isolators and hightech segregated areas
- Photochemical conversions
- Chromatographic purification
- High pressure hydrogenations
- Cryogenic reactions
- Fluorination
- Distillation column
- Biocatalytic transformation
- Controlled substances as psychotropic, lysergic acid intermediate
- Micronization
- Biotechnology expertise Gene Synthesis, Protein Expression & Production, Recombinant Peptides
- Hydride Chemistry (Lithium Alluminium hydride and Borane complex up to hundreds of kg of active)
- Cyanation (hundreds of kgs of cyanide/batch)
- Fluorination with either Electrophilic or Nucleophilic fluorinating agent (not F2)
- Large scale oxidations even in organic solvents (e.g.H2O2, HClO, Peracetic acid…)
- Bromination (up to 1,500 kg/batch)
- Carbonylation
- Organometallic reagent such as Lithium Reagents (up to hundreds of kg of active)
- Reaction with Sodium metal (up to 150 kg per production batch)
- Hydrazine/Hydroxylamine
Our analytical laboratories are skilled and equipped to provide to our customers a wide range of advanced services including chemical and solid state characterization, polymorphs services, fast analytical method development and validation, including Nitrosamines, and comprehensive quality control analytics.