Description
Simtra BioPharma Solutions is a leading contract development and manufacturing organization (CDMO), specialising in sterile injectable products.
Simtra is committed to providing high-quality, precise injectable solutions for clinical and commercial production. With a focus on collaboration, integrity, and scientific excellence, Simtra partners with clients to address complex challenges in the development, manufacturing, and delivery of injectables. The company operates two award-winning facilities in the US and Germany, which comply with cGMP standards and employ ISO 14001-certified manufacturing practices.
Key products and services:
- Formulation Development
- Lyophilization Cycle Development & Optimisation
- Rapid Technology Transfer
- Fill/Finish Operations
- Analytical Services
- Global Regulatory Support
- Delivery Options: Liquid Vials, Lyophilised Vials, Prefilled Syringes
Simtra’s dedication to quality, customer-centric service, and continuous investment in technology ensure it remains a trusted partner in the bio-pharmaceutical industry.
Capabilities
- Analytical Services
- Antibody-Drug Conjugates
- Asceptic Fill-Finish
- Biologics
- Biosimilars
- Clinical Trials
- Contract Development and Manufacturing (CDMO)
- Contract Packaging
- Cytotoxic & High Potency Compounds
- Filling
- High Containment Operations
- Injectables
- Large Volume
- Liquids
- Lyophilization
- Packaging
- Parenterals
- Parenterals Development
- Peptides
- Powders
- Process Development
- Project Management
- Quality QA/QC
- Regulatory Services
- Research & Development
- Scale-Up
- Serialization
- Solutions & Suspensions
- Stability Studies
- Sterile
- Sterile Filling
- Sterility Testing
- Sterilization
- Syringe
- Technology Transfer
- Vaccines
- Validation
- Vials