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
- Liquid Batch Sizes Up to 10,000 L
- Custom Powder Batch Sizes up to 7200 Kg
- Comprehensive documentation packages available
Quality and Compliance
Raw Material Selection & Testing
Sartorius verifies:
- 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
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 | Powder | |
Standard | On Request | Standard |
100 mL to 2 L PETE 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 | Powder bags with clamp connector |
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.
High-quality sterile filtered media and process buffer solutions that expand and extend your manufacturing capabilities.
Customized cell culture media and buffer powders are manufactured in Sartorius’ animal component-free facilities.
Sartorius produces high-quality custom acid/base and detergent solutions for downstream applications.
Liquid
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:
- PETE 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
Powder
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 7,200 kg/batch
SABADs
Strong Acids, Bases, Alcohols & Detergents for Downstream Applications
Save space and time with high-quality cleaning and conditioning agents delivered in-time for your manufacturing operation and in the packaging of your choice. Sartorius offers a comprehensive range of packaging options, including bottles and single-use Flexsafe® bags from 0.5 L to 1,000 L per unit.
Let Sartorius Handle Your Cell Culture Media & Buffer Manufacturing
Frequently Asked Questions | 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 |
|
|
|
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Table 1: Advantages and disadvantages of liquid and powdered media.
