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GMP-Creative Biolabs provides one-stop customer-oriented services including biopharmaceutical contract R&D, process development, cGMP manufacturing, QA & QC solutions for scientific research, preclinical, clinical and commercial supply. We proceed your projects according to your specific demands in quality, timeline and budget, supporting researchers across different therapeutic areas. Clear, open and regular communication with customers is as important to our success as our in-depth scientific knowledge. more
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Process Development |
Process Development
- cGMP Stable Cell Line >
  
  Microbial Cell Lines
  
  Insect Cell Lines
  
  Mammalian (non-human) Cell Lines
  
  Biosimilar Stable Cell Lines
- Upstream (Process Development) >
  
  Raw Material & Facility Supply
  
  Cell Culture Optimization
  
  Fermentation Development
- Formulation
- Cell Banking >
  
  Facility
  
  Cell Expansion, Harvest & Cryopreservation
  
  Documentation & Report
- Downstream (Process Development) >
  
  Chromatography & Elution
  
  Filtration
  
  Precipitation & Centrifugation
  
  Impurity Removal
  
  Protein Modification
  
  Process Scale-up
  
  Validation of Process Development
- Internal Reference Standard
- Analytical (Method Development) >
  
  Shape and Higher Order Structure
  
  Activity
  
  Size and Aggregation
  
  Purity
  
  Surface Charge
  
  Carbohydrate
  
  Identity
  
  Structure and Sequence
- QA Service >
  
  Viral Removal
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GMP-Creative Biolabs, One-stop, Full cGMP Service, Fasten Your Process to Cinical and Market

Process Development

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Formulation

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Creative Biolabs provides custom services for pre-formulation and formulation development studies covering different drugs. At Creative Biolabs, we have formulation experts with extensive expertise and experience to develop a variety of dosage forms. We can perform activity assay through evaluating the physical properties, solubility and stability of your active pharmaceutical ingredient (API), which facilitates identification and selection of the optimal form.

Our services for pre-formulation and formulation development include:

Physico-chemical characterization evaluation

• Density
• Particle size distribution and morphology
• Partition coefficient (Log P/LogD)
• Dissociation constant (pKa)
• Solubility in various bio-relevant media, solvents and pH
• Hygroscopicity
• Stability under different solvent and pH
• Thermal characterization
• Crystallinity
• Forced degradation study

Dosage form selection

Comprehensive excipient selection, screening and evaluation

Compatibility of API and excipient

Formulation selection, optimization and finalization

To discuss your Formulation demands or to request a proposal, please contact us.

For Research Use Only. Not For Clinical Use.

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