Top International API Supplier: Olon, a Milan-based Pharmaceutical Company, Leads Innovation in the Chemical Sector to Improve Human Health

“Being an early adopter of the most advanced technology and processes, and handling the broadest range of analytical capabilities, we represent a partner enhancing competitiveness and time to market.”

The general trend has been to steer the development of new therapies towards increasingly selective, and therefore increasingly potent, molecules, with the possibility of extending to all therapeutic areas, and in particular, oncology. Target therapies, i.e. drugs that are selective and therefore better tolerated by the patient, have an action that targets only the mechanism underlying the development of the disease. They are finding increasingly broad applications in treating the world's most widespread oncological diseases (primarily breast cancer), but also rheumatic and respiratory diseases and other major therapeutic categories with unmet needs. Improvements in treatment selectivity result in a demand for increasingly potent active pharmaceutical ingredients. To be produced, these ingredients require highly specific technologies, systems, and skills to meet the standard of containment procedures.

With that said, we’re excited to present Olon — a global leader in the development and production of active pharmaceutical ingredients (APIs) for CDMO and Generics. The company provides an integrated package of chemical synthesis and biological processing services which partners can use to manage their drug manufacturing projects fully compliant with regulations. The company relies on a global network of 11 manufacturing sites and seven R&D departments across the globe, and on several decades of experience in supporting pharmaceutical, biotech, food, chemical, and bio-industrial companies.

With 2,300 employees and 200 highly experienced and qualified people on the R&D team, Olon is a highly reliable partner.

The company is headquartered in Milan and serves clients worldwide.

The Silicon Review contacted Olon headquarters and spoke to its CEO, Paolo Tubertini, who highlighted how the company is making a difference in this segment and plans to stay at the forefront. Here’s what he said.

“We are an industry leader in applied biotechnology (industrialization and commercialization). We can manage the strong complexity implied in the tech transfer and the scale-up of the biotech process. Supported by a strong experience in developing the production process — from pilot to commercial scale, our experience in fermentation embraces managing a broad range of micro-organisms, 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. Our expertise gained over more than 50 years represents one of the most extensive know-how of microbial fermentation in Europe. And our two biotech centers (based in Italy’s Settimo Torinese and Capua) represent centers of excellence in the microbial fermentation field and meet the highest global quality standard.”

Remarkably in the field of microbial fermentation, Olon’s expertise and competence are combined with great flexibility at different levels; always considering human safety and environmental security. The company challenges and innovates the way to deliver science to improve human health, banking on creative ideas and pathways for prompt and sustainable solutions in the life science industry.

“From the start, Olon had three great strengths — expertise, innovation, and sustainability. That being said, we made a fundamental contribution to the development of one of the most effective drugs for the treatment of patients who are ill with Covid-19, by producing its active substance.”

Facilitating Stakeholder Collaboration

With 300 compounds sold worldwide, Olon has a deep knowledge of global regulations, and this represents a big value for all its partners. Olon not only follows the partner through the entire development journey but is also able to boost the product’s performance and contribute to its business success. With a portfolio of 300 Generic APIs, the company offers one of the most extensive track records in the industry and manages more than 450 Drug Master Files.

“Being an early adopter of the most advanced technology and processes, and handling the broadest range of analytical capabilities, we represent a partner enhancing competitiveness and time to market.”

‘Innovation Initiatives’ is a long-term vision that drives Olon’s growth. Our strategy of significant investments in processes, capabilities, and state-of-the-art technologies is to offer services to one of the most complete and reliable end-to-end integrated CDMO platforms globally. Olon, which in the past five years alone has more than doubled growth in strategic investments, is developing capabilities and expertise that make it the partner of choice for pharmaceutical companies, owing to the support it can provide throughout all stages of the development process. This includes new generation molecules, which are the focus of much of the research and development of the global pharmaceutical market.

“Pharma companies rely on us because we can ensure high quality and fast turnaround times. All of this is done with sustainability metrics that few other companies in our sector can offer. Our success comes from the fact that from the very start we invested heavily in innovation. At the same time, we have still maintained the agility of innovative processes that is typical of a small and medium-sized enterprise.”

Needless to say, due to its recent investments in an 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 it relies on all types of reactors regardless of required size, as well as its experience in managing high containment production processes which are among the most extensive worldwide.

Upping the Ante

Olon is developing an innovative technological platform, capable of offering extremely high-quality peptides, relying on some of the world’s most extensive expertise in the field of biomanufacturing. The company has invested in this unique know-how to expand its service portfolio.

“We are one of the few companies to have integrated know-how in both chemistry and biotechnology. In these areas, we have some of the most extensive experience on the market, especially to offer a platform to produce this type of peptide. We use recombinant DNA technology to synthesize the longest peptide chain, before chemically altering it in a selective way to integrate the unnatural amino acids.”

Olon & Sustainability

 The company’s goal is to apply a systematic sustainable approach, which covers all aspects of its business, involving people, machinery, processes, technologies, and products on a global scale, given the global size of the company.“Sustainability is something we have always worked on. We have generated significant results in cutting back on electricity and water use. We are on track for a 60 percent reduction in electricity and water use and carbon dioxide emissions between 2015 and 2025.”

“Importantly, we are increasing investments in the production of photovoltaic energy and developing new solutions to avoid wasting any energy generated in our production processes. The aggregate data of the entire Olon Group over the last five years show how our commitment to the environment has led to significant results, with the substantial halving of CO2 emissions, water and energy consumption, and waste production.”

“With a portfolio of 300 Generic APIs, Olon offers one of the most extensive track records in the industry and manages more than 450 Drug Master Files.”

“Pharma companies rely on us because we can ensure high quality and fast turnaround times. All of this is done with sustainability metrics that few other companies in our sector can offer.”