business unit of the British drug company Vectura Group Plc. Skyepharma is today a fully integrated CDMO serving the global pharmaceutical, biotech and consumer health industries. Lescuyer talks about the company’s technological competencies, its technology transfer process, its efficient ‘quality by design’ procedure and a strong organizational culture with its team spirit approach that is giving Skyepharma an edge over competition.
Skyepharma is a part of Vectura Group Plc, a British pharmaceutical company. Three years ago, Skyepharma embarked on a transformation journey from being just a drug delivery platform to a fully integrated, expert and agile CDMO (contract development and manufacturing organization), with a strong “D”, serving the global pharmaceutical, biotech, and consumer health industries.
With expertise in early stage formulation and analytical development, we are able to offer full services from development up to commercialization of oral solid dosage forms: powders, pellets, beads, granules, monolayer tablets, but also complex ones (multi-layer and tab in tab / press coated tablets).
We have several years of experience in the development and manufacture of complex oral dosage forms. We build strong and long term relationship with our clients, big pharma, virtual or startup companies. The outcomes of this effort are the 10 different oral products being currently marketed by multinational pharmaceutical companies in numerous countries worldwide.
Over the past three years, in addition to creating a strong early stage development and technological platform, professional expertise and state-of-the-art equipment, we have also made significant evolution as an organization with regard to our corporate culture. We have also instilled lean management practices across the company.
As a result, we have nurtured a strong culture that is based on respect, trust, performance, transparency and team values. The goal has been to establish an integrated organization where discussion and exchange are encouraged in daily operations.
Everyone’s involvement is required in developing a strong organizational culture. In particular, it calls for true leadership and empathy from the senior managers.
One of the keys to success is to adopt a ‘team sport’ approach, where we all have our different jobs to do and our success lies in our ability to ensure our processes flow properly between all the players. We have no stars in our team. We are all serving the team and our common goals.
We have embedded QbD (quality by design) into our early stage pharmaceutical product development process so that quality is built from the beginning. This reduces our reliance on testing of the final product to establish quality, and enhances the CDMO experience of our clients.
We leverage three of our patented technologies — Geomatrix, Geoclock and Soctec — that create a strong differentiation for us, as compared to our competitors. These platforms allow us to build controlled release formulations to adapt to patient dosing schedules or adjust API intake that help in managing side effects.
These competencies also help reduce the time to market, which is what our clients are also seeking.
Thanks to our innovative compression simulator and our efficient QbD procedure, the Skyepharma technology transfer process can be carried out in six months, instead of 10 months on average.
Our 65,000 square meter state-of-the-art facility near Lyon in France has an advanced manufacturing facility of 22,000 square meters. We have high-tech equipment that includes two integrated granulation lines of 600 liters and 1,200 liters, wet granulation and fluid bed drying, a micro fluidization line with high-pressure homogenizer equipment, and more. Our facility has eight compression suites that are able to manufacture single, two-layer, three-layer tablets, press-coated tablets and hard capsules.
Our manufacturing site is approved by European Medicines Agency (EMA), US Food and Drug Administration (FDA), ANVISA of Brazil and the Korean FDA. We have a global supply chain and currently Skyepharma is selling its pharma proprietary technologies in the US, Europe, Brazil and Asia.
All these factors allow us to offer the fastest time to market for our partners. This way, we are also able to offer flexibility on minimum order quantities.
Absolutely! An equally important facet in our transformation has been the creation of a customer service department, focused on better anticipating our clients’ needs. Clients want to be heard, they want to be able to ask for advice and share ideas. They seek a long-term partner to reflect with them on their projects.
We have created alliance teams that ensure the right understanding of the key objectives and the strategy of our clients.
Although there are several large players in the CDMO sector, we see several small to mid-size CMOs/CROs growing and there is room for expansion, in particular for an agile CDMO like Skyepharma. The CDMO space is very fragmented and it is important that we continue to differentiate ourselves in order to stay ahead of the competition on the complex solid forms segment.
We have created a center of excellence for classic and complex oral solid dosage forms using our technologies. We are also developing new technologies for new formulations, that should benefit patients.