INITS Group

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Contact

location_on

474 allée Henri II de Montmorency, Immeuble Carré Montmorency
34000 Montpellier
France

public

https://inits.fr/

Christelle ROCHON
Head of Strategic Partnerships & BD
mail

c.rochon@inits.fr

call

+33 6 31 88 19 88

About us

Founded in 2013 and based in Montpellier, France, INITS is a consultancy firm supporting biotech companies in France and internationally.

 

With a team of experts dedicated to their projects, INITS has always dared to adopt different and disruptive approaches.

Business offer

We are specialized in drug development support and management, covering CMC (Chemistry, Manufacturing, and Controls), IMP (Investigational Medicinal Products), regulatory, quality assurance and audits.

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In response to our clients' evolving requirements, we have been working for the past three years on the establishment of a new shared manufacturing unit, INITS-SMO. This innovative model, inspired by the DIY, is designed for biotech companies which want to keep control on their manufacturing process.

 

INITS supports its clients across the entire pharmaceutical development chain for biological drugs (gene and cell therapy products, exosomes, monoclonal antibodies, etc.), covering areas such as CMC (Chemistry Manufacturing and Controls), IMP (Investigational Medicinal Products), Regulatory Affairs, Quality Assurance, and Audits.

 

In response to the evolving needs of biotech companies, INITS has been working for several years on implementing an innovative bioproduction services concept: INITS SMO (Shared Manufacturing Organization). This groundbreaking approach to bioproduction will allow biotech companies to implement their innovative processes and conduct GMP productions themselves with INITS' support.

 

For more information about INITS, visit https://inits.fr.

Activities

    Categories

    • Service
    • Consulting

    Therapeutic applications

    • Cardiology
    • Genetic Diseases
    • Oncology
    • Nervous Central System
    • Hematology
    • Infectiology
    • Immunology
    • Ophthalmology
    • Inflammation

    Expertises

    Directory of Antibodies, Recombinant proteins and others
    • CMC
    • GLP compliance
    • GLP compliance
    • Master Cell Bank
    • Production
    • Cell Line development
    • Clone selection
    • Characterization
    • Storage
    • Analytical development
    • Cell Culture
    • Media composition
    • Bioreactor conditions
    • Gene modification / Transduction
    • Retroviral & lentiviral vectors
    • Cell expansion
    • Wave-mixed bioreactors
    • Stirred tank reactors
    • Bioproduction
    • Batches production type
    • Mammalian
    • Insect
    • Yeast
    • Bacterial
    • GLP compliance
    • GMP compliance
    • Pilot Batches
    • Tests
    • Optimization
    • Scale-Up process
    • Process optimization & validation
    • Volume
    • Preclinical / Tox
    • Low volume (< 200 L)
    • High volume (200 – 2000 L)
    • Very high volume (> 2000 L)
    • Commercial
    • USP (Scale-Up)
    • Cell expansion
    • Inoculation
    • Low volume containers to Bioreactors
    • DSP (Recovery)
    • Harvest
    • Filtration
    • Purification
    • Fill & Finish
    • Aseptic filling
    • Lyophilization
    • Batch release
    • Storage matter
    • Instruction
    • Logistic
    • Cell cryopreservation
    • Controlled-rated freezer
    • thaw
    • Quality assurance, quality control & analytical process
    • Stability Assessment
    • Physical & chemical profile
    • Shear/shaking
    • Viscosity
    • Photostability
    • pH
    • Freeze/thaw
    • Heat/degradation
    • Aggregation
    • Cell line analytical development
    • Host cell proteins
    • Viral clearance
    • Contaminants detection
    • Biosafety & Bioanalysis
    • Toxicology
    • PK/PD features
    • Impurities detection
    • Bioproduction analytical test
    • Monitoring
    • Characterization
    • Batch consistency
    • Batch release test
    • Chemical, physical, biological test
    • Quality control test support
    • Post-production test
    • Real-time stability test
    • Formulation
    • Formulation
    • Dose
    • Stability
    • Excipients
    • Adjuvants
    • Sterilization
    • Lyophilization
    • Storage stability
    • Clinical trials
    • Phase I
    • Phase II
    • Phase III
    Cell Therapy Directory
    • CMC/analytical quality assessment, quality control
    • Cleaning
    • Cross contamination
    • Sterility
    • Contaminants detection
    • Safety for gene-edited cells
    • translocation
    • anti-nuclease response
    • cytokine-independent growth
    • Non-clinical safety and toxicology studies
    • Bioproduction engineering
    • Cell Expansion
    • Stirred tank Bioreactor
    • Wave bioreactor
    • Cell factory
    • Capsules culture
    • Scale-Up
    • Process optimization
    • Automated manufacturing
    • On-line monitoring
    • Automated high throughput microbioreactor system
    • Non-GMP expansion
    • GMP expansion
    • Other
    • Purification/Extraction
    • Filtration / microfiltration / ultrafiltration
    • Centrifugation
    • Chromatography
    • CGMP
    • Formulation
    • Conditioning
    • Storage
    • Delivery
    • Transport
    • Supply chain logistics
    • Tracking process
    • Monitoring logistics
    Gene and CAR-T cell therapy Directory
    • Ex Vivo & In Vivo Strategy
    • Ex Vivo & In Vivo Strategy
    • Bioproduction/CMC/Analytical Quality Assessment, Quality Control
    • Bioproduction
    • Scale-Up
    • Automated manufacturing
    • Automated high throughput microbioreactor system
    • Supply chain logistics
    • Tracking process
    • Monitoring logistics
    • Non-GMP pilot batch
    • GMP batch
    • Cleaning
    • CGMP
    • Sterility
    • Deviations
    • Quality control
    • Contaminants detection
    • Non-clinical safety and toxicology studies
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