CDMO

Through chemical synthesis, microbial biomanufacturing or a semi-synthesis approach, we offer, under GMP, dedicated solutions for the development and manufacturing of NCEs, advanced Intermediates, building blocks, enzymes & proteins, peptides of rDNA origin, high potency drugs, controlled substances and food bio manufacturing.

Olon is enabler of:

  • Capabilities
  • Sustainability
  • Reliability
  • Expertise

We guarantee customer support from the R&D lab up to full-scale commercial manufacturing and strong regulatory support. Our experience and global footprint allow us to follow the entire process in house, with a single point of contact for the customer and complete accountability.

Along the process of technology transfer and product development, our Partners are fully supported by a dedicated team applying the guidelines of the project management approach. The appointed team is accountable for planning and tracking activities, resolving conflicts of resources, solving critical issues, and communicating news and updates; while the technical team, which provides regular updates on the project status (Reports - TCs), communicates directly with the customer for technical topics, and supports the regulatory strategy.

Olon CDMO expertise, facts and figures

Technical Capabilities and R&D

Combining well established and novel practices for efficient and successful manufacturing, ensuring safe, fast and cost-effective commercial processes.

Technologies

One of the widest range of leading-edge technologies chemistry and biotechnology expertise.

  • High Potent Compound handling capabilities
  • Filter driers, isolators and high-tech segregated areas
  • Photochemical conversions
  • Chromatographic purification
  • High-pressure hydrogenations
  • Cryogenic reactions, Hydrogenation also for acidic substances, Fluorination
  • Distillation column
  • Biocatalytic transformation
  • Controlled substances such as psychotropic, lysergic acid intermediate
  • Micronization
  • Biotechnology expertise in Gene Synthesis, Protein Expression & Production, Recombinant Peptides

Hazardous Chemistry

  • 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 reagents such as Lithium Reagents (up to hundreds of kg of active)
  • Reaction with Sodium metal (up to 150 kg per production batch)
  • Hydrazine/Hydroxylamine
Analytical capabilities

Analytical capabilities

Our level of manufacturing capacity is customized to your needs and objectives.
We are one of the few able to implement in-house Nitrosamine analysis.

  • Atomic Spectroscopy
  • UPLCs, HPLCs, prep-HPLCs, GC
  • LC/MS, GC/MS
  • NMR
  • Molecular Spectroscopy
  • Thermal Analysis
  • X-ray
  • Physical Testing - Particle size, microscopy, osmometry, dissolution, hygroscopicity, viscosity, surface tension
  • Isolation - Semi-prep chromatography
  • Stability - Reach-in and walk-in sized stability chambers, forced degradation, photostability
Olon Biotech

Olon Biotech

Olon is a global partner of CDMO services in the field of microbial fermentation.

We are an industry leader in applied biotechnology to industrialization and commercialization, able to manage the strong complexity implied in the tech transfer and in the scale-up of the biotech process.
Endorsed by a strong experience in developing the production process from pilot to commercial scale, our experience in fermentation embraces managing a broad range of microorganisms such as bacteria, yeast, and fungi. We offer strong expertise from small molecules to large molecules – peptides, enzymes, proteins and rely on a highly skilled team of operators.
Olon expertise gained over more than 50 years, represents one of the most extensive know-how of microbial fermentation in Europe.

We have two Biotech Centers, based in Settimo Torinese and Capua (Italy) that represent centers of excellence in the microbial fermentation field, meeting the highest global quality standard. Our Biotech Centers are multipurpose and able to manage the highest complexity; they are endowed with unique flexibility and diverse capabilities thanks to the competencies gained by applying different manufacturing processes for different products and reach a total fermentation capacity of 4.900 m3.

Olon is also developing one of the market’s most innovative technological platforms, capable of offering high-quality peptides.
We are one of the few companies able to integrate expertise in the two areas of chemistry and biotechnology, in both of which we have extensive experience, to offer seamless platforms combining two processes meeting the needs of our Partner.

Advanced High Containment

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, OEB5, 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.

Today we are one of the few CDMO companies to offer the range 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.

1 to 5 kg Rodano site
10-20 kg Segrate site,
small size plant
30 kg Rodano site,
new line
Largest
size
Rodano site
Microbial Fermentation
Chemical Synthesis
Advanced High Containment
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