Services
R&D and Manufacturing Facility Set-up
- Concept design, basic and detail design
- High-end equipment evaluation and selection
- Market assessment and product selection
- Roadmap for product development plan
- Facility establishment, commissioning
- Qualification and handover
- Project management support
Process Development and Optimization
- Clone, process and platform evaluation
- Process development (single and multi-use) to achieve consistent titre and quality
- Upstream and downstream process optimization to achieve high titres/yields
- Use of DoE and PAT tools for process development and selection
- Analytical and bioassay method development, qualification and transfer
- Analytical and bioassay method development, qualification and transfer
- Documentation for tech transfer and regulatory compliance
- Specification and design space identification
Licensing The Technology
- Selection of the technology/know-how for successful development
- Technical assessment and networking with trusted partners
- Risk assessment
- Technology transfer and successful Replication (R&D or manufacturing)
- Handholding and technical support throughout
Process Scale-up (Single or Mutli-Use)
- Process scale-up plan and prediction (Single and Multi-use)
- Quality system development in manufacturing
- Method validation, product release and stability study
- Use of AI/ML tools for success in manufacturing scale-up
- Minimizing risk of failure
Regulatory
Services
Services
- Guidance for regulatory landscape
- CMC preparation and dossier Submission
- Scientific advice package and submission
- Selection of CRO for pre-clinical and clinical studies
