Accelerate Your Program — Outsource Your Media & Buffer Production
Industry-Leading Manufacturing Capabilities and Quality Assurance
There is never enough time or capacity to make everything required for the production of a biologic, so turn to Sartorius and trust our commitment to quality and material compliance. Our global media and buffer manufacturing facilities meet the industry’s strict regulatory production and distribution standards.
- ISO 9001: 2015 and ISO 13485 certification when applicable
- Liquid batch sizes up to 10,000 L
- Custom powder batch sizes up to 7000 Kg
- Comprehensive documentation packages available
Quality and Compliance
Raw Material Selection & Testing
Sartorius verifies through our global raw material qualification program:
- Quality classification for all raw materials
- Specification and quality (USP, EP, JP) of raw materials and the track record of the material and supplier
- Traceability of the supplier’s measurement data
Sartorius carefully monitors:
- Bioburden quantification for defined|critical raw materials
- Moisture analysis for defined|classified components
- Mandatory batch documentation (e.g., CoA, CoO, and CoP)
- Expiry or retest dates, as well as retest procedures
Product Release Testing|Product Quality Attributes
Before QC release, a batch’s biological, chemical, and physical quality attributes are tested according to respective guidelines. Each batch of liquid, and dry-powdered media, and supplements must comply with the defined product-specific quality parameters of the quality attributes listed in Table 1 and 2.
Liquid Release Testing | |
Property | Test |
Biological | Endotoxin |
Sterility | |
Chemical | Osmolality |
pH | |
Physical | Appearance |
Solubility | |
Powder Release Testing | |
Property | Test |
Biological | Endotoxin |
Bioburden | |
Chemical | Osmolality |
pH | |
Physical | Appearance |
Moisture | |
All of our products come with their respective certificates and documents, such as:
- Product-specific documents, including:
- Material safety data sheets (MSDSs)
- Protocols for use (PFUs)
- Certificate of origin
- Lot-specific documents, including:
- Certificates of compliance|analysis
- Certification ISO 13485 when applicable and ISO 9001: 2015
Packaging & Logistics
Depending on the quantity, size and sensitivity of the media product, Sartorius offers a range of packaging and shipping solutions, including ready-to-use and customized options, (Table 1). All products are stored in temperature-monitored cold storage until they are ready to be shipped.
Liquid - Standard | Liquid - On Request | Powder - Standard |
|---|---|---|
100 mL to 2 L PET Bottle | Customer-specific bottles | Pharma-grade container with outliner |
1 L to 20 L 2D Bags | 2D bags with customer-specific tubing or connectors | Drums with pharma-grade in-liner bags |
50 L to 1000 L 3D Bags | 3D bags with customer-specific tubing or connectors |
Table 1
We express ship our media globally using preselected transportation partners that guarantee to meet our products’ specific quality requirements. We offer temperature monitoring and have multiple cooling options available. Depending on the destination and quantity of goods, several container options are also available.
Liquid
High-quality sterile filtered media and process buffer solutions that expand and extend your manufacturing capabilities.
Powder
Customized cell culture media and buffer powders are manufactured in Sartorius’ animal component-free facilities.
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.
Rely on Sartorius for Custom Liquid Media & Buffer Manufacturing
From pilot-scale to large-scale cGMP manufacturing, rely on Sartorius for high-quality cell culture media and process buffers delivered in-time for your manufacturing runs. Sartorius offers varied packaging options, including single-use Flexsafe® bags.
- Animal component-free manufacturing facilities
- Batch Size: Up to 10,000 L
- Flexible filling options:
- PET Bottles: 100 mL to 2 L
- 2D Single-Use Flexsafe® bags: 250 mL to 20 L
- 3D Single-Use Flexsafe® bags: 50 L to 1,000 L
- Sterile filtered
Custom Powder Media and Buffer Manufacturing at Small and Large Scale
Sartorius’ manufacturing services for customized powder media and buffers include both non-GMP pilot-scale manufacturing and large-scale cGMP production in animal component–free facilities.
- Flexible filling options range from 125 g bottles to 100+ kg drums
- Batch sizes range from 1 to 7000 kg/batch
Let Sartorius Handle Your Cell Culture Media & Buffer Manufacturing
Media & Buffer Manufacturing at Sartorius
Liquid or Powder?
Liquid cell culture media, supplements and buffers are preferred over powdered alternatives for small-scale testing and short-term use. Dry-powdered products have advantages for large-scale projects.
Liquid | Powder | ||
Advantages | Disadvantages | Advantages | Disadvantages |
|
|
|
|
Table 1: Advantages and disadvantages of liquid and powdered media.
