A forward-thinking attitude

Cerbios’ experience in the pharmaceutical field has its roots in the early 1930s when the Company founders set an initial target to serve the pharma sector in Southern Switzerland.

Subsequently, in the 1970s, biological and chemical process capabilities were added to Cerbios’ portfolio upgrading company know-how to the next stage.

Cerbios was then on the front line to foresee the rise in offering comprehensive services for APIs along the drug products’ different developmental stages. Since then, it has been investing heavily in API-related R&D and manufacturing capabilities.

By keeping an innovative attitude, the company always focused on introducing the most advanced technologies and forward-thinking projects.

Over the last 20 years its value proposition has strengthened in the highly active API sector, continually expanding its offerings for advanced CDMO services on HPAPIs and ADCs.

Cerbios’ long-standing experience in the pharma world, combined with an aim to innovate alongside a customer-oriented culture, make the company a unique partner.

It offers both a portfolio of generic APIs/HPAPIs and state-of-the-art CDMO services, while retaining the ability to make every customer feel valued.

The qualities appreciated the most by Cerbios’ partners are the commitment to quality at every level of the organisation, an open and constructive communication, the responsiveness and rapid decision-making, the continuous investment in new technologies and the rich competencies to fulfil each customer need.

Such attributes are essential in meeting and anticipating the rapidly changing requirements of customers and authorities, made ever more difficult by unpredictable global scenarios.

Along the journey, Cerbios’ mindset and actions have always been inspired by four main values that have moulded its core identity and still act today as the company beacon: Responsibility, Quality, Reliability and Collaboration. Such values were already part of the founders’ DNA and have been passed to generations of shareholders, managers and employees who have shaped the company hallmarks in the proceeding years.

ADCs: a natural step

As CDMO, Cerbios is recognised today as a front-runner in the ADC landscape owing to its ability to provide CDMO services for the development and manufacturing of ADCs and all its components (mAb, linker/payload, conjugate) within a single site. This position has been achieved via company know-how built up in the last 20 years along with a unique expertise in mastering both highly potent chemicals and large biological molecules.

When ADCs start the route to becoming commercial drugs, it was immediately clear what was next company objective. The last few years has seen Cerbios further focusing on ADCs, creating the Proveo ™ division as one of the core business pillars in the company.              Proveo extends Cerbios’ capacity through the partnership with two leading companies: AGC Biologics, for large scale protein manufacturing and Oncotec for Aseptic Filling & Lyophilisation services.  The target of this division is to offer end-to-end solutions from cell line development, large scale protein manufacturing, linker/payload manufacturing to ADC DS and DP manufacturing.

On this basis, Proveo meets the demands of small to large pharma companies, supporting their programs from early stage up to commercial supply for ADC and related components.

It is well known that the complexity of an ADC project brings unique requirements, where each component or activity may require specific and diversified expertise.

Therefore, customers usually rely on different CDMO partners with a limited view on the overall project along with a different mindset and contract forms.

Having the opportunity to cooperate with a single partner that provides end-to-end solutions, optimises the project by streamlining each phase. The main advantages for customers are therefore:

• Relying on an integrated Development, Analytical and Project Management system
• Centralising all contractual aspects in a single document signed by a sole partner
• Securing in place a Unified Quality Agreement
• Profiting from an integrated supply chain between the manufacturing facilities

Raise the bar

Innovation follows the same pace as investments and in this context, was sensible of the Cerbios Board to steadily push company growth.

Recently, in 2021, Cerbios completed and received SwissMedic approval for a new HPAPI unit, which upgraded its HPAPI manufacturing capacities by up to 30 Kg/batch.

Additionally, in 2022 a new R&D unit was created, which increased the R&D capacity for the development of HPAPIs by 50% and doubled the capacity for R&D analytical services.

The latest news concerns the finalisation of a new building that will shortly be inspected by Swiss Medic, with plans to be fully operational in April 2023.

This will add two complete lines for HPAPI manufacturing, primarily dedicated to ADC linker-payloads and cytotoxic APIs.

The new facility features low- and high-pressure chromatography, lyophilisation and nanofiltration that are required for the manufacture of complex molecules.

The future will see Cerbios expanding capacity, with the target to double ADC capacity by investing in a new hub. The ultimate aim is to expand the company commitment to provide best-in-class bioconjugation services for the worldwide partners.

In parallel, the company’s Corporate Social Responsibility has always been a driver in the company strategy alongside its Environmental, Social, and Governance improvement, that is focused on the reduction of the carbon footprint.

Climate change gaining more importance and is one of the major challenges faced by the industry. The healthcare system accounts today for about 6% of greenhouse gas emissions, making this a crucial aspect to immediately address.

In 2021, COP26 put in place a long-term program to build health systems which are able to withstand the impacts of climate change and which are low carbon and sustainable. In addition, the EU in the same period and with similar scope issued the “Fit for 55” package.

Taking into account both external and internal targets, Cerbios is continually striving to implement greener technologies and processes that reduce environmental impact and produce significantly lower waste material.

In this context, the company will implement new processes to collect and separate the exhausted solvents, resulting in reduced waste and increased recycling.

Additionally, investment in photovoltaic panels and in recovering passive heat are being implemented. The combination of these projects will lead to a 40% reduction of natural gas used and to a reduction of 600 t/year of CO2 emissions. As a collateral benefit, this will also reduce the risk of business interruption as an energy contingency.

Think out-of-the-box

Cerbios always aims to be innovative in the communication field and find the right way to steer the audience to the core message of the company.

Cerbios takes steps to interact with Pharma’s diverse audience that is not always an easy task considering the range and specialties of the services the company offers.

A shift of mindset in the marketing approach was identified as a necessary step, resulting in a a no-frills, cross-group message agreed upon, based on the company value proposition.

On the basis of such premises, Cerbios prepared a new advertisement (Figure 1) that will be distributed throughout 2023, starting at DCAT where the new communication campaign will be visible in an animated form on the DCAT Week TV.

Valentino Mandelli manages Cerbios’ Generic APIs market in America, MENA and Asia regions as well as overseeing the expansion of the CDMO partnerships for HPAPIs.

Valentino joined Cerbios in 2021, bringing his experience as a medicinal chemist and contributing over 10 years expertise in the commercial field of APIs.