Research & Development

Early-stage development

Benefit from our extensive experience in solving complex formulation development challenges. Our experts will advise you on the best solution to optimise drug delivery for the benefit of the patients.

You can choose to include our range of proprietary technologies to provide modified release, pulse or timed release profiles:

  • to solve technological challenges;
  • to provide patient benefits;
  • to offer additional proprietary protection to the product.
Learn more about our proprietary technologies
STYL'One development

Prototyping in development and laboratory scale

To save your time and money, we realize flexible prototyping essays on early characterized powders leading to the anticipation of potential up-scaling issues.

We use compression simulator (Styl’One Evolution) and low-scale equipment which reproduce industrial processes such as wet granulation and compression including tabletting, roller compaction and coating.

Compression simulator assets for formulation development:

  1. Small API needed for small-scale production;
  2. High-quality prototyping with rapid screening of formulation options;
  3. Study of parameter impact on product specifications;

 

  • Rapid Technology transfer;
  • Process validation;
  • Design of Experiment support (QbD);
  • Process robustness;
  • Delivery of cGMP and non-cGMP prototypes.

Development at the clinical trial scale ​

One of Skyepharma’s key differentiators is that we offer flexible batch size development and manufacturing services. This includes clinical trial material development.

Once formulation development is validated, we use our cGMP facilities to supply the product for clinical studies.

Regulatory support is provided to assist you during the clinical phases.

Optimisation of complex formulation

Our technical team has considerable experience in the optimisation of complex formulations in order to ensure that the critical process parameters are properly understood and controlled, and that the processes are cost-effective and robust at multiple scales for  seamless transfer to production.

We can offer trouble shooting resolution, all being supported by a Quality by Design approach.

Quality by Design methodology (QbD)

Quality by Design is a development methodology that focuses on a systematic evaluation of the chosen development method. This approach allows for continuous control and improvement of quality. 

Quality by Design aims to better understand the characteristics of molecules to master the manufacturing process by identifying critical parameters.

We have expertise and extensive experience in Quality by Design methodology, using the following tools:

– FMEA risk assessments (Failure Mode and Effects Analysis for global risk assessment => determination of the most critical process step);

– FTA risk assessments (Fault Tree Analysis for determination of the potential CPP having an impact on CQA);

– DOE (Design of Experiments for determination of the influence of each CPP on th CQA);

– Statistical data analysis with Minitab software.

Quality by design

Analytical method development

At Skyepharma your product development is closely supported by an experienced analytical team throughout every phase of the development process. This team has an expertise in method development and an extensive experience in risk management, enabling them to proactively identify and resolve potential issues.

Thanks to this expertise, we are able to develop analytical methods on a time, from literature review and parameter screening to sample preparation and robustness assessment.

Here are the services we offer for analytical development : 

  • Analysis of all R&D samples and technical batches

  • Follow-up of the analysis of the prototyping formulation during the early-stage development

  • Evaluation of the deterrent properties of formulations, recommended by recent regulatory guidelines

  • Special support services such as high storage capacities for stability studies : 19 rooms (conditions ICH 25/60 30/65 40/75 30/75, and refrigerated conditions)

  • Method development and method optimization (such as liquid chromatography)

  • Identification by Mass Spectrometry (Q-TOF)

  • Characterization of powders with BET / Particle size analyzer

  • Infrastructure suitable for the handling of narcotic drugs or controlled substances

  • Laboratory rooms equipped with yellow light for handling photosensitive compounds

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