Formulation Platform
Sterile Finished Dosage Form (FDF) Platform
Raysun is developing an integrated finished-dosage-form platform in Vientiane, Laos, focused on sterile drug-product development and manufacturing support for peptide and other selected programs. The platform is intended to connect formulation development, analytical planning, presentation selection and technology-transfer preparation within one coordinated project framework.
Planned Formulation & Fill-Finish Scope
- Liquid and lyophilized vial presentations
- Formulation and process-development support
- Container-closure and compatibility planning
- Technology-transfer and manufacturing-readiness preparation
The planned sterile line incorporates Truking equipment for coordinated vial preparation, aseptic processing and downstream handling. Current design information includes automated vial washing and depyrogenation, aseptic filling, a 10 m² shelf lyophilizer with service-side access and a designed line speed of 80–120 vials per minute.
Project-Specific Review
Molecule characteristics, dosage form, container-closure system, batch scale, analytical requirements, documentation and regulatory pathway will be assessed before final deliverables, manufacturing arrangements and timelines are confirmed.
Raysun Corporate Film
From Peptide API to Sterile FDF
Formulation, Fill-Finish & Lyophilization
Explore Raysun's integrated vision for peptide APIs and sterile finished dosage forms. The corporate film introduces the company's development direction, planned manufacturing platform and project-based approach to formulation, aseptic fill-finish, lyophilization and coordinated CDMO support.
Sterile Dosage Forms
Injection Formulation
Raysun is developing a vial-based sterile formulation and fill-finish platform supported by Truking equipment. The planned workflow connects formulation preparation, sterile filtration, automated vial washing and depyrogenation, aseptic filling, lyophilization and coordinated downstream handling. Product format, fill volume, batch scale, container-closure system and qualification requirements will be confirmed through project-specific technical review.
Applicable Process
| Process | Primary Container | Planned Support |
|---|---|---|
| Formulation Preparation | Sterile Vial | Solution preparation and project-specific formulation processing |
| Sterile Filtration | Sterile Vial | Product-specific filtration strategy and process-transfer planning |
| Vial Preparation | Sterile Vial | Automated vial washing and depyrogenation |
| Aseptic Filling | Sterile Vial | Planned filling for liquid and lyophilized presentations |
| Lyophilization | Sterile Vial | Cycle-development support using the planned 10 m² shelf lyophilizer |
| Downstream Handling | Sterile Vial | Coordinated post-filling and container-handling workflow |
Platform Design Information
| Design Item | Confirmed Information |
|---|---|
| Equipment Partner | Truking |
| Primary Presentation | Sterile vials |
| Vial Preparation | Automated washing and depyrogenation |
| Filling Format | Aseptic liquid filling |
| Lyophilizer Shelf Area | 10 m² |
| Lyophilizer Access | Service-side access |
| Designed Line Speed | 80–120 vials per minute |
| Fill Volume & Batch Range | Confirmed through project-specific technical review |
Selected Solid Dosage Projects
Solid Dosage Formulation Development
Raysun evaluates selected solid dosage formulation projects on a case-by-case basis. Potential work packages may cover pre-formulation assessment, excipient compatibility, dosage-form selection, prototype development, analytical planning and technology-transfer preparation. Final scope and manufacturing arrangements are confirmed only after technical and regulatory review.
Development Scope
| Development Area | Potential Support | Status |
|---|---|---|
| Pre-formulation Assessment | Solubility, stability and excipient-compatibility review | Project-specific |
| Formulation Screening | Selection of excipients and preliminary composition | Project-specific |
| Tablet Development | Target profile, prototype and process-planning support | Subject to review |
| Capsule Development | Capsule-format and fill-composition assessment | Subject to review |
| Analytical Planning | Method, specification and stability-study planning | Project-specific |
| Technology Transfer | Documentation and external manufacturing-transfer preparation | Project-specific |
Presentation & Packaging Assessment
| Presentation | Planning Support |
|---|---|
| Tablets | Bottle or blister presentation assessment |
| Hard Capsules | Bottle or blister presentation assessment |
| Powder or Granules | Sachet or bottle presentation assessment |
| Other Formats | Evaluated according to product requirements |
Solid dosage projects are accepted selectively. Equipment availability, manufacturing site, scale, packaging format and regulatory deliverables are confirmed separately for each project.
Final formulation scope, product presentation, analytical package, manufacturing arrangements and timelines are confirmed only after project-specific technical and regulatory review.