Clinical trial material (CTM) manufacturing and release

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. Soctec® is a versatile extended release gastro-retentive platform technology that ...

Our proprietary medicated chewing gum technology uses an approach similar to multilayer tableting. A combination of layers modulates the release rate of the active ingredients and flavouring agents when the gum is chewed.

By using microfluidization technology process, Skyepharma provides solution to increase bioavailabity of poorly soluble APIs (micro and nanoparticule). It is also an interesting technology for micro and nano emulsion manufacturing.

NDA/ANDA MAA-CTD writing Regulatory support

Certifications : FDA, Europe, ANVISA, Korean FDA etc.

We have extensive experience in solving complex formulation challenges. Our experts can apply our extensive range of proprietary technologies for immediate (IR) and modified (MR) / sustained, slow (SR) / controlled (CR) / extended (XR, ER) / pulsed / timed release as well as enteric and gastro reten...

Manufacturing of classic and complex oral solid dosage forms:  single layer tablets, multi-layer tablets, tab-in-tab, tab-in-caps, hard gel capsules, powder & pellets.

Our analytical experienced team support the pharmaceutical development during every phase of the development process. Analytical development transfer and validation, characterization capabilities, stability analysis, ICH Q3D (residuals solvent risk assesment), ICHQ3C (elemental impurities risk assesment...

Skyepharma is experienced with the scale-up of complex oral solid dosage forms from laboratory to pilot-scale and full commercial scale manufacturing. We have powerfull compaction simulation tools ( STYL'One evolution) allowing to derisk and fasten scale-up steps. 
Our capabilities :...

Primary packaging: Forming station for both PVCs and aluminium and all kind of feeder for tablets and capsules. Secondary packaging: Labelling, carton and casepacker.

Primary packaging : Plastic and glass bottles (round and square) loading station. Secondary packaging : sealing, labelling, carton and casepacker.

We can offer batch sizes from a few kilograms to several hundreds and the equipment is versatile in terms of material: powder, granules or pellets can be filled with PET / ALU / PE complex films up to 17 mm wide and up to 150 mm long. 

Using Veratrak's platform, the CDMO will have full oversight of data, including an audit trail of data and document processes

In this article, Mathieu Degomme, PharmD, Pharmaceutical Development Project Manager, and Aline Moulin, PhD, Pharmaceutical Development Director, both of Skyepharma, outline three case studies from recent early-stage development programmes to illustrate what kind of complex tablets can be developed to meet specific target dissolution profiles for versatile applications.

R&D : Mechanical resistance of pharmaceutical press coated tablets (tab-in-tab): characterization and link with material and process parameters.

Through 25 years of involvement and achievements in the pharmaceutical industry, Skyepharma’s development and manufacturing facility is a leader in the field of classic and complex oral solid dosage forms.

Several ongoing development programs are dedicated to the manufacturing of orphan drugs intended for both US and European patients. Skyepharma team is proud to work on orphan drugs development projects.

We support our clients through the whole product value chain with expert teams involved at the very beginning of every project. - Pharmaceutical development services - Technology offer for complex oral solid forms - Analytical services - Manufacturing & packaging capabilities - Serialization & aggregation service ready

This article describes the robustness of Skyepharma's supply chain. The delivery of our products has not been impacted during this COVID-19 pandemic. Discover how!

Skyepharma has extended its serialisation and aggregation service to ‘hard to reach’ countries like Russia and Brazil. We are now able to offer serialized and aggregated supplies to Russia.

Skyepharma is a full CDMO. We have an analytical service that covers all aspects from development to manufacturing. Packaging, raw materials and finished products are all controlled by this service.

Aline Moulin,  Head of New Product Introduction Department (NPI), presented different case studies during the Pharma Insight Briefings 2018 (CPHI Worldiwide): "COMPACTION SIMULATION AS A POWERFUL QUALITY BY DESIGN (QbD) TOOL How Skyepharma can help you to shorten the time and reduce the cost of pharmaceutical development programmes"

The serialization system allows the verification of a drug's compliance from the distribution to the delivery then to the patient. This article explains the serialization and aggregation implemented at Skyepharma.

David Lescuyer, Executive Vice President and Frederic Checo, Pharmaceutical Development Leader, both from Skyepharma speaks with CPHI TV at CPHI Worldwide in Madrid, Spain

Since 2018, oral dosage CDMO Skyepharma radically updated and expanded its packaging capabilities, opening new packaging lines equipped for serialization and aggregation.

Lucile Kowalsky, Project Manager in the New Product Introduction (NPI) department presented a case study during the Pharma Insight Briefings (CPHI Worldwide 2017) : "Quality by Design and Expertise:Accelerating time to market of complex oral solid dosage Accelerating time to market."

- Bottle packaging - Blister packaging 
- Stick-packs 
- Serialization & aggregation services (Seavision systems)

Skyepharma is a french fully integrated CDMO with expertise in classic & complex oral solid dosage forms offering : Development, Manufacturing and Packaging services.  As a fully integrated CDMO Skyepharma provides tailor-made solutions to customers by positioning itself as an integrated partner offering a wide range of premium services.  
Our experienced team of specialists works to optimize target product profile and drug development program from early formulation development, scale-up, manufacturing and packaging to regulatory support.

For Skyepharma, to be agile qualifies our ability to mobilize experts and work together to solve complex efficiently and rapidly. Skyepharma, your AGILE CDMO partner for tailor-made solutions.

For Skyepharma, being reliable means taht we are able to meet our customers' needs on time and to the expected level of quality. Skyepharma your reliable CDMO for faster time to market without compromising on product quality

We are able to develop analytical methods in a limited time, from bibliography study, screening parameters and conditions to sample preparation and assessment of robustness.

.Skyepharma's interview shows the company's growth since last year. David Lescuyer, Florence Lemoult and Frédéric Checot are the interviewees