Bespoke Media & Buffers Contract Manufacturing Services
Benefit from flexible and scalable capabilities
Confidently entrust your liquid & powder established formulations to our production facilities. Seamlessly scale up from smaller prototypes all the way to qualified large batches, leaning on 20+ years of experience in cell culture media and a vast array of packaging, formats, and release assays options.
Up to 3 kg | 100 L batches for expedited delivery. Products are manufactured with same raw materials as larger batches
Up to 20kg | 200 L for proof of concept in exact same equipment setup as larger batches
Up to 1 ton | 5,500 L* per batch for research and further manufacturing use, suitable for cGMP environment
*installed capacity & equipment, further expansion ongoing
Key Features of Our Powder & Liquid Capabilities
Powder
From Prototype to Pilot and Large-Scale Batches for Powder Production
- Lean process: reduced & homogenous particle size, controlled milling for consistent characteristics
- Large-scale manufacturing in ISO 8 clean room following cGMP referential
- Packing in plastic buckets to 100+ kg drums
- Qualified raw materials in highest possible grade (EP | USP | JP when applicable)
Liquid
From Prototype to Pilot and Large-Scale Batches for Liquid Production
- In-house WFI-quality water loop
- Filling in closed, aseptic conditions in ISO 5 clean environment
- Primary packaging from PET bottles to single-use 2D and 3D Flexsafe® bags
- Qualified raw materials in highest possible grade (EP | USP | JP when applicable)
Comprehensive Quality Documentation
Comprehensive quality documentation available for each production, based on requirements
| Quality Documentation Package | Standard products | Custom products |
|---|---|---|
| Product Specifications | ||
| Certificate of Analysis (CoA) | ||
| Shelf-life statement | ||
| Animal Origin | TSE | BSE statement | ||
| Nitrosamine statement | ||
| GMO statement | ||
| Elemental impurities statement | ||
| Melamine statement | ||
| Residual solvent statement | ||
| Allergens statement |
= Available by default
= Project-dependent or on request
Get the Right Support When You Are Scaling Up
Dedicated Production According to Your Needs
Sartorius proprietary media formulations can be customized based on your needs
- Change in components, packaging, quality testing, additional documentation
- Quality & Regulatory support as well as documentation can be provided on an ad-hoc basis
Ready to Outsource? We Have the Options You Need
Focus on your core expertise, and rely on ready-to-use liquids or pre-made powders
- Based on a streamlined process, a project team takes your request all the way to production
- Every aspect of your project is thoroughly evaluated from individual compounds to packaging, release testing, and shipping & storage conditions
- Additional services can be considered incl. tailored stability studies
- Various legal documents can be put in place: Confidentiality Agreements, Supply & Quality Agreements
De-risk Your Raw Materials Supply
From WFI-quality water to the most popular saline solutions, to buffer concentrates, secure your supply of downstream buffer formulations from one single source.
- Based on a streamlined process, a project team takes your request all the way to production
- Every aspect of your project is thoroughly evaluated from individual compounds to packaging, release testing, and shipping & storage conditions
- Additional services can be considered incl. tailored stability studies
- Various legal documents can be put in place: Confidentiality Agreements, Supply & Quality Agreements
Manufacturing Facility for Cell Culture Media in Puerto Rico
Have a look at our facility tour video, showcasing a new manufacturing area for cell culture media with 2,000m2 dedicated to powder production.
