Services
Product Selection & Clone Development
Product selection considers commercial feasibility before progressing to clone development.
Key capabilities
- Market and regulatory assessment
- Vector selection and gene synthesis
- Construct design and clone selection
Upstream Process Development
Fermentation experience supports bacterial and mammalian process development.
Key capabilities
- Bacterial processes
- Mammalian processes
- Process scale-up
Downstream Process Development
Purification experience complements upstream development across biosimilar projects.
Key capabilities
- Purification development
- Insulin and antibody process experience
Formulation Development
Formulations are optimized for protein stability and comparability.
Key capabilities
- Buffer and excipient selection
- Stress testing
- Container-closure studies
Fill-Finish Development
Fill-finish formats are selected to suit the biosimilar.
Key capabilities
- Vial presentations
- Pens and cartridges
- Prefilled syringe formats
Analytical Method Development
Methods support biosimilar testing and batch release.
Key capabilities
- Protein and impurity testing
- Chromatography and bioassays
- Method verification and validation
Dossier Preparation
Development studies inform dossiers for domestic and international submissions.
Key capabilities
- Manufacturing documentation
- Characterization and control information
Biosimilar Technology Transfer
Transfer support connects recombinant cell lines with finished-product development.
Key capabilities
- Process and formulation transfer
- Technical documentation
Regulatory Support
Regulatory assistance spans research through launch.
Key capabilities
- Scale-up support
- Clinical-stage support
- Manufacturing and marketing submissions
Conceptual Facility Design
Facility concepts reflect process needs and manufacturing flexibility.
Key capabilities
- Process-flow planning
- Capacity considerations
- cGMP design requirements
Quality Management Systems
Quality systems connect procedures, people, and improvement.
Key capabilities
- Policies and procedures
- Risk, change, and deviation management
- Corrective actions and training
Discuss Your Project
Connect with Lyotex Life Sciences about your development, quality, and technology-transfer requirements.