3Biotech

MABDESIGN MEMBER

About us

3biotech is a company specialized in CMC and pharmaceutical development. We support our customers from the research phase to the first human injection and commercialization.

Know-how

CMC
Bioproduction
Biomanufacturing
Drug Development

Business offer

• We define, in agreement with our client, the drug development strategy (Target Product Profile, development plan, preclinical studies ...),
• We offer the most appropriate technological solutions (cell lines, manufacturing processes, analytical methods, ...),
• We select, worldwide, the most appropriate CRO / CDMOs for the project,
• We lead and coordinate all stakeholders and ensure timelines, quality and cost
• We program and monitor the production of clinical batches,
• We help with the writing of IMPD and IND, ....

Field of application
  • antibodies
  • cellular immunotherapy
Therapeutic application
  • cardiology
  • genetic diseases
  • hematology
  • infectiology
  • immunology
  • oncology
  • ophtalmology

Expertise

  • Manufacturability
  • Production quality
  • CMC feasibility
  • Indication Prioritization
  • Antibody humanization
  • Proof of concept
  • Pharmacology potency
  • Exploratory toxicology
  • in-vitro & ex-vivo models
  • in-vivo models
  • GLP compliance
  • GMP 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
  • Batches production type
  • Mammalian
  • Insect
  • 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
  • thaw
  • 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
  • Dose
  • Stability
  • Excipients
  • Adjuvants
  • Sterilization
  • Lyophilization
  • Storage stability
  • Delivery
  • Route of Administration
  • Phase I
  • Phase II
  • Phase III

Category

  • Service

Contact