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Skyepharma Production S.A.S.
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.
As an integrated CDMO, Skyepharma’s controlled-release technologies and oral solids products offer solution for development, manufacturing and packaging of classic and complex oral solid dosage forms, including single layer tablets, multi-layer tablets, tab-in-tab, tab-in-caps, hard gel capsules and sachets.
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 seven core areas of expertise and capability:
- Formulation Development & Process Design: Leveraging from extensive experience to solve complex formulation challenges, applying an extensive range of proprietary technologies for modified release, pulsed release, timed release, etc. to provide patient benefits and offer additional proprietary protection to products.
- Analytical Development: Deploying experienced analytical teams to support pharmaceutical development across the whole value chain, including analytical validation, characterization capabilities, stability analysis, ICH Q3D and E/L capabilities.
- Scale-up: Skyepharma is experienced with the scale-up of complex oral solid dosage forms from laboratory to pilot-scale and full commercial scale manufacturing.
- Manufacturing: production of single layer tablets, multi-layer tablets, tab-in-tab, tab-in-caps, hard gel capsules and sachets.
- Microfluidizer technology: Using microfluidization technology to provide solutions that increase bioavailability of poorly soluble APIs as well as possibilities for micro and nano emulsion manufacturing.
- Packaging in Blister: Primary packaging using forming stations for both PVC and aluminium and all kind of feeders for tablets and capsules, combined with secondary packaging (carton, labelling, and casepacker).
- Packaging in Bottle: Primary packaging in plastic or glass bottles with secondary packaging including sealing, labelling and cartoning.
- Serialization and aggregation for both bottle and blister lines.
Skyepharma 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:
- Controlled substance handling.
- Quality by Design methodology .(FMEA, FTA, DOE).
- Trouble shooting.
- Regulatory services (NDA/ANDA, MAA-CTD writing, etc.)
- Validation and registration (experience in EU/US dossier submission).
- Warehousing services.
Through acquisition and in-house development, Skyepharma has built up a portfolio of world-class patented technologies that apply to oral delivery mechanisms. These include:
Geoclock®: a validated oral drug delivery technology that allows for timed release of active ingredient from the tablet, independent of food or pH. Geoclock® can additionally be used for multiple pulse delivery of one or more drugs with pre-determined time intervals between the pulses, or to target colonic release of drugs. Where more than one drug is included, the delivery profile can be different for each API. Geoclock® is easily manufactured using conventional production equipment, minimizing the need for capital investment.
Soctec® : Skyepharma’s latest innovation, Soctec®, was developed for drugs that need to be retained in the stomach for an extended period of time to then being slowly released either for a local effect in the stomach or for absorption in the upper intestine. This is a versatile extended release gastro-retentive platform technology designed to overcome many of the limitations of alternative systems while improving oral bioavailability and duration of action for sustained release formulations.
Geomatrix® : Geomatrix® is a well-established, validated and customizable oral drug delivery platform technology that enables controlled release versions of orally available molecules. Geomatrix® is highly versatile and applicable across a wide range of different drugs to achieve a variety of different release profiles. It is currently used in eight products currently marketed in more than 80 countries. It uses well-established ingredients and is easily manufactured using conventional production equipment.
Skyepharma can also develop technologies for clients. It is currently developing for Novartis an mdDPI Foradil (formoterol) that will be approved in more than 30 countries including the USA. The Saint Quentin site will ensure the filling of DPI over its patented market life.
Structure and history:
Skyepharma is the oral business unit of the Vectura Group of companies, an international leader in inhalation and other drug delivery forms.
Skyepharma was originally founded in 1983 as the creation of JAGO AG by Jacques Gonnella, a small Swiss private company specialized in development. In 1990, JAGO acquired the first Geomatrix patent from the University of Pavia, allowing the creation of its drug delivery business, soon validated by the approval in the USA of the first product based on Dilacor technology developed on behalf of RPR.
In 1996, Ian Gowrie-Smith, founder of Medeva, created Skyepharma plc as a virtual entity. Using funds from the sale of Medeva, Skyepharma then acquired JAGO AG, trading under that brand before rebranding as Skyepharma AG two years later, shortly after the acquisition of its Saint Quentin Fallavier production site from Wyeth. Skyepharma has subsequently invested in the site to adapt it to the production of modified-release tablets, particularly those using the patented Geomatrix technology. The manufacture of these tablets began in the pilot plant in December 1998 for a US generic and led to eventual FDA certification of the site.
In 2016, a merger between Skyepharma Plc and Vectura created Skyepharma Production as an entity to perform Oral Business Unit activities.
Quality and Regulatory
Skyepharma is certified as compliant with EU Good Manufacturing Practice (GMP) for Human Medicinal Products, US GMP Code of Federal Regulations Title 21, Parts 210 and 211 and ANVISA RDC N°17, 04/2010 as amended by RDC n°33, 08/2015 and subsequent resolutions.
The company is authorized by ANSM as a manufacturer and importer of human medicinal products and human investigational medicinal products delivered and registered by the US FDA as a Drug Establishment authorized for analysis, label, manufacture, and pack operations.
Skyepharma internal quality control processes govern production, process validation in manufacturing, analytical methods, cleaning, data integrity and control of documentation and records for full traceability.
The Skyepharma Operational Excellence Program focuses on a ‘right first time’ approach, with continuous development of team expertise and focus on key quality processes such as deviation management, CAPA, change control, risk management, handling of complaints, product release, etc.
The Board of Directors is committed to regularly evaluating and continuously improving the quality management system in place and the internal control systems providing oversight of GMP operations.