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Shared Manufacturing Organization (SMO)

Our new concept, Inits SMO, will offer to biotech companies R&D and GMP compliant environment, supported by our experts up to product release.

www.atypik-studio.com @2023 - Archigroup Grand sud 

logo-INITS-SMO

INITS SMO is a shared bioproduction unit for preclinical and clinical trials.

Committed to the highest technological standards, this initiative allows companies to retain control over their manufacturing processes and intellectual property. Our unique infrastructure and a team of specialists from across the cell and gene therapy life cycle, who can collaborate with you to find solutions to your ATMP challenges.

Groundbreaking for the new facility will take place in the first quarter of 2024, and the building will be operational by the end of 2025, with commissioning scheduled for early 2026.

AN ANSWER TO

  • Strong growth in demand for manufacturing capacity

  • Long waiting times

  • Intellectual property at risk

  • Expanding biomanufacturing capacity in France

  • Strengthening biomanufacturing education

KEY BENEFITS FOR BIOTECH

Secure and maintain control of:

  • Intellectual Property

  • Technological advantages

  • Less risks of failure: the biotech knows its process

  • Simplifing and securing process: a single partner for the entire production chain

  • Reduce costs

“INITS SMO aims to give biotech companies back their control over production, while ensuring the quality standards required for human clinical trials.”

INITS SMO will offer 3200sqm of flexible  production space adapted to all technologies. From the development phase to final batch production and final certification, our client will benefit from our state-of-the-art equipment and technologies, to manage the transfer and execution of their manufacturing processes. 

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YOUR OWN MANUFACTURING

Companies will be able to manufacture their APIs (Pharmaceutical Ingredient) using qualified equipment in a GMP-compliant environment, where the confidentiality of each project remains absolute.

A UNIQUE EXPERTISE

INITS SMO will provide its expertise throughout this process to cover all aspects necessary to produce compliant drugs: regulatory, quality assurance, quality control, supply management, project management...

Develop and produce your own product (Drug Substance) in a privileged and supported GMP environment

fil and finish

GMP & R&D suits

With

  • Specific access

  • Dedicated offices​

  • Dedicated advanced storage

  • Customer GMP zone clearance

SMO

"Best in Class" Equipments

R&D Bioreactors: 2-10L
GMP Bioreactors: 50-200L

  • Qualified equipment

  • User training

  • Cleaning and maintenance

  • Integration/qualification of customer equipment 

SMO expertise

SMO Supports

  • Product development strategy

  • Regulatory

  • Technical/Production Support

  • Quality Assurance

  • GMP Training

  • Project Management

  • Supply chain 

  • Quality Control Services

  • QP Services

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