Biosimilar development support
Biosimilar Development Support at Stancor Pharma
In the complex world of biosimilar development, ensuring product integrity is vital. Stancor Pharma’s contract manufacturing capabilities provide reliable support for your specific requirements.
The wear problem
In biosimilar production, wear can occur through sliding abrasion during the mixing and processing of formulations. This often leads to significant equipment wear, particularly in high-shear mixers and pumps, affecting product quality and delivery timelines.
Recommended plate by component
| Component | Grade | Thickness | Why |
|---|---|---|---|
| high-shear mixer blades | contrast media | 5-10 | Extended service life due to resistance to wear. |
| pumps | oncology injectables | 10-15 | Minimization of downtime from wear-related failures. |
| mixing containers | biosimilar development programmes | 3-5 | Enhanced durability ensuring consistent quality in formulation. |
| filter membranes | cosmetics | 2-4 | Improved filtration performance with reduced wear and tear. |
| universal joint couplings | general injectables | 8-12 | Better performance longevity through superior material selection. |
Selecting the right plate
Assess facility capabilities
Ensure the facility can meet your specific production and quality standards.
Understand batch-size limits
Choose a manufacturer that can handle your required batch sizes efficiently.
Check analytical methods
Confirm that the analytical methodologies align with your product requirements.
Review technology transfer processes
Select a manufacturer with robust technology transfer protocols to avoid delays.
Questions engineers ask
How does wear affect biosimilar production?
Wear can lead to contamination and inconsistencies in formulations, jeopardizing product safety. Minimizing wear through quality materials enhances reliability.
What formulation capabilities does Stancor Pharma offer?
We offer extensive capabilities in biosimilar development, ensuring that our processes align with rigorous industry standards. Our focus is on formulation capabilities without labeling approved products.
What are the benefits of outsourcing biosimilar development?
Outsourcing can streamline operations while allowing access to specialized expertise and facilities. This helps maintain focus on core competencies while enhancing product quality.
How can I ensure compliance in contract manufacturing?
Choose a partner with a proven track record in GMP facilities and necessary approvals. Compliance verification is crucial before starting any contract.
Get a quotation for biosimilar development support
Send your specification and requirement and we respond with options and a full release data pack.
Request a quotation