Solving Complex Chemical Problems Across All Phases of NCE Programs

Solving Complex Chemical Problems Across All Phases of NCE Programs

October 21, 2021PAO-10-21-CL-11

With at least one acquisition taking place annually since 2016, Olon Ricerca Bioscience is fully equipped to service the global market. CEO Luigi Trussardo discusses the company's string of aggressive acquisitions and the recent expansion into the North American market. Going beyond the standard CDMO role, Olon Ricerca Bioscience supports customers as a consultant beginning with the RFP stage, advising partner biotechs on feasibility, cost-effective next steps, and how to achieve commercialization, no matter how complex the chemistry.

David Alvaro (DA): I understand that you have an important announcement about the next strategic milestone of Olon Ricerca Bioscience.

Luigi Trussardo (LT): One of the latest investments for Olon Ricerca Bioscience is a new space for the production of highly potent APIs (HPAPIs). Olon has years of expertise in HPAPIs, especially in Italy. It’s essential that Ricerca is aligned with that technology, as we want to bring on clients that need HPAPIs in clinical phases, as early as possible. Now we offer HPAPIs for early clinical phases and then transfer programs to the European sites for later-phase clinical and beyond.

We’ve begun this investment in HPAPI capabilities and have already contracted with an engineering firm. Over the long term, we plan to increase our capacity to meet demand up to a hundred grams. We want our U.S. site to mirror the capacity of the Italian facility, which includes multiple sites that are able to perform the production of HPAPIs on a larger scale.

When Olon strategically acquired Ricerca Biosciences’ chemical division, our U.S. footprint was established. We also expanded our capacity, closing the gap between preclinical phase and commercial production, where we already played, and adding on capabilities for the initial development of new chemical entities (NCEs).

Now, we can take clients from preclinical to phase II and then, if the project is successful, transfer the technology to our European sites for phase III/commercial. We offer our customers a full partnership from preclinical up to commercial. Although we don’t carry out production from start to finish of the API development at the same site, our customers appreciate the fact that their program can be completed through a single provider. To date, we have several examples demonstrating the smooth technological transfer of processes and analytics between the two side of the ocean within the same quality and operational system.

DA: What types of customers and programs is Olon Ricerca Bioscience able to support?

LT: Olon Ricerca Bioscience works with all companies, from smaller biotech and virtual companies to Big Pharma. We largely service biotechs, because that’s where the demand for NCEs is concentrated. In terms of size, we work with small biotech and mid-size pharma. Clients will typically reach out to us when they are looking to scale up medicinal chemistry products into a phase I process; we provide the material for tox and phase I studies.

We also offer analytical methods development/validation and can help our clients achieve success from the clinical phases on. Now that Ricerca Bioscience is part of the larger Olon group, we can provide our clients with a wider safety net and no longer have to end our partnerships once phase II/III is complete. Now, we tell our partners that we assume responsibility and will transfer the product to our sites in Europe for commercial production.

DA: Do you feel that Olon Ricerca Bioscience is a particularly good organizational fit for those smaller biotech companies?

LT: Definitely; small biotech organizations are a great fit for Olon Ricerca. What helps us stand out from potential competitors is that we assume a consultant role for this type of client based on our outstanding experience in regulatory, safety, and large-scale process development, as they often lack the level of internal expertise that larger organizations have. In most cases, we partner with these small biotechs and provide advice as well as suggestions about the next steps, depending on the clinical phase. Beginning with the RFP, we schedule an initial call with the client where we can provide our expertise and demonstrate an understanding of their needs. In some cases, what’s being requested is not exactly what is needed for that clinical phase — we take on the role of pro bono consultants for certain clients so they can advance their molecules more cost-effectively.

The U.S. biotech industry is booming, especially on the west and east coasts, which is why it was so crucial for us to establish roots in the North American market. Our clients appreciate how accessible we now are, and that they can have a conversation with us in the same time zone. This is especially key considering the fact that we handle the very delicate initial phases of API development.

DA: Olon Ricerca Bioscience is a competitive center, not only scientifically but in terms of attracting talent. Is there anything else you could tell me about your development in terms of human resources and how you are able to attract such top talent?

LT: Being part of a larger organization like Olon has definitely helped broaden our reach, as candidates are excited by the prospect of serving clients in North America, Europe, and Asia. Our exposure has increased along with our workforce, which has grown by 10–15% in only the last few years. As our efforts to develop our HPAPI capabilities ramp up, we’re looking for qualified candidates with specialization in this area. Again, we are continually looking for new talent to enrich our organization. We are currently looking to recruit candidates with quality assurance and process chemistry experience.

Over the last 18 months, the entire organization has been involved with at least four or five projects that are related to COVID-19. We were deeply involved in the fight against the pandemic and working toward developing a cure. In my opinion, this is a very exciting environment for scientists, because you’re involved in something that everybody is talking about and you’re helping people treat an illness that is impacting the whole world.

Another, more obvious way that we attract talent is through a competitive benefits package that includes compensation for relocation. As the company is going through so much expansion, there are ample opportunities to grow professionally at Olon Ricerca Bioscience.


DA: How do you see Olon Ricerca Bioscience positioned in both the North American and European markets, and how do you think the external perception matches the reality?

LT: Even before being acquired by Olon, Ricerca was perceived as a reliable provider of initial clinical development with years of technical expertise. We would receive positive feedback from more than 90% of our customers, especially regarding our people and ability to deliver — because we would deliver exactly what we promised, on-spec and according to the timeline. We’re highly transparent with our clients starting from the proposal stage and will let them know if a timeline is unrealistic or if there’s a quicker, better way of doing things while maintaining the same level of quality.

The only concern clients would express to me was doubt about Ricerca’s financial stability, which is no longer a relevant question following our merger with Olon; we are enjoying the benefits of being part of a larger group. Our current goal is to be perceived as a full-service partner, and we are working on communicating this message to customers and providing an understanding of Olon’s offering to the North American market.

DA: What drives Olon Ricerca Bioscience’s ability to solve complex chemical problems?

LTIt all comes down to our people, who are experts at what they do. Our approach from the outset is to loop in someone with chemistry expertise to evaluate the RFP and prepare our proposal. There is always a chemist behind our client work who will go above and beyond to check the weak points of the process that we are going to evaluate. This person can suggest a new vision or a different approach to the problem that the client may have had with other suppliers. In some cases, the client is coming from a pure university research background, and they will sometimes provide an extremely complex process that is not possible to industrialize. However, our chemists figure this out and create a process that is scalable through to commercial.  From the beginning, our clients notice the impact of our people as they advise them on what has to be done to efficiently move onward.

We have several examples of clients that were sending us RFPs and very openly saying, “We’ve tried three times in the past to overcome these kinds of problems, and we never were successful, and this is the last attempt that we are going to have in order to progress with the API.” In all of these cases, Olon Ricerca was able to provide a reliable process so they could be successful.

Our problem-solving ability stems from a combination of our expert team and our internal network, as we encourage collaboration and the exchange of ideas. 

DA: Looking forward through the next decade, what kind of changes do you anticipate in terms of client needs?

LT: While it’s difficult to predict the future, clients are becoming more and more specialized in specific therapeutic areas and processes, which has prompted Olon to also move in that direction and tailor our services to tackle this trend.

Overall, the high-potency business is booming — HPAPIs are no longer exclusively used in oncology. Olon is investing in that area and other technologies. We also expect research on NCEs to continue. 

Twenty years ago, pharma giants did the research, but now this responsibility has largely shifted to the biotechs. It’s essentials for providers to have an internal structure that can support small companies, who are likely to command the most success in the future. I don’t foresee global companies being a progressive partner for new molecules in 10 years.

I believe the micronization of companies developing NCEs will be even more widespread. Again, this is why it’s important to capture every single company and product so they can be readily developed in the future. In my opinion, a company that is structured to be 100% dedicated to small biotechs is going to be successful in the future.

DA: Can you walk me through the company’s different sites and how they function together as a network to support customer needs?

LTOlon Ricerca is located in northeast Ohio, 30 miles east of Cleveland. Our campus consists of two buildings and is divided into four operation departments.

We have an analytical department that provides a comprehensive range of on-site analytical chemistry services to fully support the drug development process, from preclinical to postmarketing phases. We have decades of experience conducting studies in compliance with the U.S. FDA – GLP/cGMP regulatory requirements and the International Conference on Harmonization (ICH). We also provide this offering as a standalone business. Our clients can take advantage of our analytical services even without producing API in our site.

Our synthetic chemistry group comprises 20 people who are providing services supporting the discovery phase (early-stage scaffold/analog synthesis, lead optimization, preclinical compound synthesis support to acute/tox studies), with preparation of milligram to kilogram amounts for active ingredients and advanced intermediates, as well as metabolites/Impurities and reference standards.

We then have two groups that are more dedicated to GMP — process chemistry and process development and manufacturing. Process chemistry includes the chemists that support the progression of drug candidates and specialty materials through all phases of development and manufacture. In process development and manufacturing, we produce APIs and intermediates. Our site includes 17 cubic meters of reactors and four kilo labs that are GMP, as well as six general purpose labs. We are capable of production in our pilot plant from small batch size up to 100–150 kilos/batch. We are proficient in a diverse range of organic chemical reactions and excel at combining them into a safe, reliable, efficient, and cost-effective manufacturing process for your APIs, intermediates, regulatory starting materials, and performance chemicals. There are 105 people working on site, the majority of whom have technical experience, whether they are process/synthetic/analytical chemists or engineers.

Within the company, Olon Ricerca Bioscience is perceived as a research unit. Olon Group has a total of 2,200 employees and 11 manufacturing sites worldwide. Nine are located in Europe, one is located in the United States — Olon Ricerca Bioscience — and one is located in India — Olon India. Our total capacity across the Olon group is more than 7,000 cubic meters. This impressive space is complemented by a range of technology, from chemical to fermentation production.

The company has grown quite dramatically over the last several years. In 2015, Olon was a five-site group located in Italy. In 2016, we acquired the Infa Group, and in 2017 we acquired the chemical division of Ricerca Biosciences. In 2018–2019, we acquired the site of Capua BioServices, located in southern Italy, and a manufacturing plant in India, which was previously a Novartis site. Within only six years, the company has more than doubled from five sites to 11. At the same time, the group also expanded organically by taking on new clients and expanding production.

Olon Ricerca is part of the Olon CDMO Business Unit offering our expertise in contract development and manufacturing services with several decades of experience in supporting pharmaceutical, biotech, food, chemical, and bio-industrial companies.

Our CDMO services are based on chemical as well as fermentation-based technologies, with specific expertise in GMP manufacturing, as well as food-grade, F&F, and agro manufacturing.

DA: What do you envision will be the next big thing in pharma? Do you foresee a disruptive paradigm-shifting trend of any kind, such as a new technology, approach, or modality on the horizon that may shake things up?

LTAll signs point to a patient-centric approach to gene and other therapies, which will be developed for individuals. The industry is moving in that direction, but to do so requires more data about each patient. Pharmaceutical companies are trying to acquire databanks more and more frequently, and I imagine that mapping a patient’s DNA is going to be an important factor for therapies going forward.

With products being tailored to the individual, it’s likely that side effects will be minimized. The typical approach of a large-spectrum drug, which is more effective for some patients and less so for others, will become outdated.

Another ethical consideration is how we can afford this kind of approach from an economic standpoint. While I support patient-centricity, I would like to see this kind of development being made more affordable so larger patient populations can take advantage. My hope is for a real game-changer technology that addresses a specific patient’s needs but is also affordable for the majority of patients worldwide. I believe this is the real challenge; instead of looking for maximum profitability for every single therapy, the industry should take a more to holistic approach and strive to make the latest technologies in healthcare accessible.

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