Skyepharma presents

Agile and innovative solution for biotechnology development

We make your biotech project come true

More than CDMO Faster than greenfield approach Tailor-made & build-on facility Intellectual property protection

All-in-one solution for your biotech project

Skyehub-Bioproduction® by Skyepharma is a unique and tailor-made biotechnology support offer. It consists in providing biotech companies with a built-on-demand, fully equipped GMP facility, along with a highly approved and already implemented pharmaceutical quality system, as well as on-demand expert human resources. Skyehub stands apart from typical CDMO services as it allows you to strictly control your intellectual property and know-how.

Our mission is to support you with everything you need to manage but can’t handle by yourself, in order to accelerate the  advancement and value of your new biotech project and bring it faster to market.

At which step of the project development do we intervene?

We support you from early-stage development to the industrial stage, making your scale-up faster and safer.

  • Preclinical Development

    Animal proof of concept/ regulatory PK-PD and toxicity study

  • Early-stage Clinical Development

    Phase 1 / First In Man

  • Clinical Trial

    Phase 2 

  • Late-stage clinical development

    Phase 3 launching

  • Process Optimization & industrialization

    Facility for manufacturing 

  • Product registration

    MA file submission

  • Commercial Manufacturing

    Phase 4 / Quality Management 

What do we offer ?

GMP facility specifically adapted to your needs

In the context of our  partnership, Skyepharma provides you with a new highly equipped modular building specifically designed for your individual biotech project. An example of such building entirely dedicated to the development of biotechnologies for the production of our first biotech partner MaaT Pharma’s biomedicines, is presented here below.

Pharmaceutical Quality System

  • Quality Compliant Building
  • Equipment Qualification
  • Quality Control
  • Facility Qualifications
  • Advanced Computer Validation
  • Thorough Process Validation
  • Operationnal Quality Expertise
  • Qualified Person Assistance
  • Documentation System Integration

Industrial Support

  • Management of IT Network (ERP, Business Software)
  • HR Department
  • Purchasing and Supply Chain Department
  • Production
  • Packaging Department
  • Maintenance Department (Utility Management, Regulatory Department, HSE and CSR)
  • Parking, Cafeteria access for your staff…

Quality Compliance

Skyepharma and its bioproduction department benefit from a strong regulatory track record. Our quality environment is compliant with the requirements of French health authorities (ANSM) and international authorities including the USA (FDA), Brazil (ANVISA), Europe, and Latin America. 

GMP
ANSM
ANVISA
Skyehub® offers more than a simple CDMO does

Build a production facility or subcontract ?
Why not get the best of both ?

At Skyehub-Bioproduction®, we understand the challenges and risks associated with developing biotech products. That is why we offer state-of-the-art facility and equipment, combined with our CDMO expertise and pharmaceutical quality systems management, to accelerate your biotech product development. We offer flexible and customizable solutions that are tailored to meet your specific needs and help you to quickly scale up from start-up to an industrial company, ensuring the success of your biotech project. Choose Skyehub as your bioproduction partner and let us help you bring your ideas to life.

Your company's value accelerator

Accelerate your company's value and your biotech project maturity through our continuous support and experience sharing.

Access to the GMP environment

Benefit from our years of expertise in the pharmaceutical quality system. You don't need to have any knowledge of GMP procedures.

Guidance by the recognized industry expert

Skyepharma has a strong reputation and over 25 years of experience in pharmaceutical development and manufacturing.

Contact us

Client's case study

Skyepharma and MaaT Pharma have entered in February 2022 a partnership to establish in the Skyehub-Bioproduction® the first exclusive microbiome ecosystem therapies cGMP manufacturing facility in France.

More than 1600m² dedicated to Microbiome Ecosystem Therapies™

  • Start of construction : 07/2022
  • Delivery : 08/2023
  • R&D laboratory : 234m²
  • Production facilities : 564m²
  • BSL2 | Class D | cGMP
  • Storage: 100m² (2 levels)
  • Administrative & technical areas: +700m²
  • Biobased materials

cGMP production capacity to support clinical and commercial plans

  • Production of clinical and commercial batches of drug candidates MaaT013 and MaaT033 in oncohematology
  • Development of R&D and clinical batches of MaaT03X (range of targeted Microbiome Ecosystem Therapies produced by co-culture)
  • Acceleration of R&D at MaaT Pharma
Auvergne-Rhône-Alpes.

We are supported by France 2030 and the Auvergne-Rhone-Alpes région