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Skyepharma achieved its transformation into an integrated, agile and expert CDMO, able to develop, manufacture and package complex oral solid forms
Saint-Quentin-Fallavier, France: – Over the past 36 months, oral dosage specialist Skyepharma Productions S.A.S. (Skyepharma) has undergone a significant and highly successful transformation with over €10 million in investments at its production site near Lyon in France.
Skyepharma has been transforming its processes and facilities to support its mission to become an end-to-end contract development and manufacturing organisation (CDMO), providing services extending from early stage development and manufacturing through to packaging, serialization and aggregation.
Major investments have been made to expand development and packaging. The company has invested in two brand new packaging lines for bottles and blisters and soon in a third packaging line for sachets.
Skyepharma’s journey began in July 2016 and has been organised around four core strands of activity: culture change, pharmaceutical development growth, strong investments in industrial equipment and business development.
President of Skyepharma, David Lescuyer, has been reflecting on the changes in an interview by the online magazine PharmaBoardRoom.
Mr. Lescuyer told the magazine that the transformation had involved investment in new machinery, along with evolutions in the organization, corporate culture and embracing lean management practices across the company.
Faster time to market and API savings
“In Skyepharma, we have nurtured a strong culture based on respect, trust, performance, transparency, and team values not only internally but with our clients as well. The goal over these three years was about to establish an integrated organization where discussion and exchange are encouraged in daily operations. Since then, we have increased our team size by 20 professionals, including three PhDs, two pharmacists and many engineers,” said Mr. Lescuyer.
He said Skyepharma was able to enjoy comparative advantage within the CDMO sector through its distinctive ability to produce complex oral solid forms ranging from capsules, granules, tablets, and more. Through technological know-how, use of innovative compression simulators, technology transfer processes and in-house developed quality by design (QbD) disciplines; it could help clients reduce time to market.
Serialization and Aggregation opportunities
He said new regulations emphasizing serialization presented a major opportunity for Skyepharma.
“There will be a natural selection of players, between those who are prepared to meet the regulatory requirements and those which are not. Keeping up with the constantly increasing regulatory requirements allow us to offer up-to-date services to our partners. We have had for instance pharmaceutical companies approach us as they were unable to serialize or aggregate their products with their previous CMO partner.
“For Skyepharma, serialization and aggregation are very favorable entry doors to expand our client network and create new business activities, such as supply chain improvement projects,” said Mr. Lescuyer.
“We are uniquely positioned as a developer and producer of complex solid dosage forms with a distinct drug delivery platform and an agile proficiency to work alongside our partners and solve healthcare complexity,” Mr. Lescuyer concluded.
About Skyepharma Production
Skyepharma Production S.A.S. (Skyepharma) is a specialist CDMO with particular expertise and capabilities in oral solid dosage forms, being a key player in drug development and delivery of oral technologies serving the global pharmaceutical, biotech and consumer health industries.
Skyepharma is the oral business unit of the Vectura Group of companies, an international leader in inhalation and other drug delivery forms.
As an integrated CDMO, The company’s vision is to help solve healthcare industry complexity with a mission to provide a dedicated and results-oriented team to deliver advanced oral dosage services to the healthcare industry through state-of-the-art facilities, scientific expertise and open, transparent relationships. All of this is summed up in its strapline: ‘Expert and Agile CDMO partner for tailor-made solutions’.
The Skyepharma CDMO offer in solid oral dosage formats encompasses the whole value chain, including Formulation Development & Process Design, Analytical Development, Scale-up, Manufacturing, Packaging, Serialization and Aggregation.
Skyepharma also provides a range of support services that help client companies from early stage development (up to phase III), through scale-up and full commercial manufacturing and packaging to market introduction, including controlled substance handling, QbD methodology (FMEA, FTA, DOE), Troubleshooting, regulatory services, validation, registration and warehousing services.