Novasep
Providing flexible Manufacturing Solutions for Pharma Innovators

As Jean Blehaut, President of Novasep Pharma Solutions Business Unit, says, “Novasep’s DNA is founded on 5 core values, namely integrity, innovation, teamwork, and commitment, all forming our customer focus. This is what drives Novasep forward and keeps us one step ahead in the Life Science industry.” This is demonstrated by extraordinarily strong growth, “this growth is in part driven by a large number of our customers that recently obtained regulatory approval from the FDA and other regulatory institutions, for APIs manufactured on our sites”, adds Jean Blehaut.

Novasep offers a wide range of CDMO services to Pharmaceutical Innovators through its Pharma Solutions Business Unit. The company is at the forefront of delivering clinical development and commercial manufacturing services for active pharmaceutical ingredients (APIs) based on process development expertise, a multi-site API manufacturing network & an outstanding regulatory track-record.

The company offers a broad chemistry toolbox, complemented by an unrivalled pool of specialized technologies, including HPAPIs, ADCs, hazardous chemistry & industrial chromatography, “Technology is a strong differentiating asset and we continue to build on it. For instance, we have been developing our Flow Chemistry expertise for almost 10 years and we are currently expanding these capabilities”, states Blehaut.

With 5 cGMP manufacturing sites, Novasep supports its customers all over the world. The power of its network also lies in its ability to manage several steps of chemistry through different sites to provide increased volumes and to ensure business continuity.

In recent years, the clinical pipeline for small molecule drugs has continued to demonstrate strong growth.This dynamic pipeline, resulting in an increasing number of new drug approvals, has focused pharmaceutical companies’ attention on securing supply chains. Driven by development in targeted therapies, for example in the oncology area, the demand for flexible capacity, large and small, is huge. Innovators can leverage Novasep’s flexible CDMO solutions for APIs & intermediates at a wide range of production scales – from grams to tons – for clinical & commercial needs and secure their long-term supply chains. “Today’s challenge is making sure that our customers can benefit from the adequate capacity to match with their volume requirements in this growing market.”

We aim to be a highly respected, and an innovative partner providing life sciences solutions for our clients and their patients in all our market segments through the passion of our people and the excellence of our processes

It’s the sense of Novasep investment strategy: the company is constantly investing to upgrade and make its sites more flexible to better answer clients’ needs.

Recently, Novasep announced a €6.5 million investment to expand capacity & increase flexibility in an API manufacturing workshop on its Chassesur- Rhône site, in France. A further investment of €4 million was announced for the expansion of its Highly Potent Active Pharmaceutical Ingredients (HPAPIs) manufacturing capabilities on its Le Mans site, in France, as a result of longstanding collaborations with major pharmaceutical companies & new partnerships with biotechnology innovators.

“Our investments enable us to offer capacities and to improve flexibility and productivity for our clients. They also help us to reduce our environmental impact by optimizing energy consumption. This is an opportunity for us to respond to social and environmental challenges using technology.”

Flexibility is key at Novasep whether it is about capacity or about managing changes during the development process “We have a very strong organization of Project Managers, who take care of customers product in development stage and then Product Owners, when our customers product has reached commercial stage, to ensure regulatory compliance, supply chain and business continuity.”

Innovation is in the DNA of Novasep. Today it translates into the trend towards digitization which spans from implementing electronic batch records, applying data mining to better characterise process or managing remote quality audits. “We build upon digitization to fuel our growth”.

Besides its technological offerings and services, one of the main reasons, according to Blehaut, that has made Novasep a success, is its people. “We believe that our people are the main asset of the company,” he adds. The company works continuously to upskill its employees, and to this effect, the ‘Novasep University’ was established, focused on four key areas. First, the Novasep Business Academy helps employees learn business management and strategy. The Novasep Management School provides a consistent management training based upon 5 key management roles. The Novasep Sales College was also founded to help the company develop the business acumen of its sales and business team. And finally, Novasep Continuous Improvement School provides focused training on operational excellence, principles and methodologies. “We aim to be a highly respected, and an innovative partner providing life sciences solutions for our clients and their patients in all our market segments through the passion of our people and the excellence of our processes”, concludes Blehaut.