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.

icon-water-drops

Liquid

High-quality sterile filtered media and process buffer solutions that expand and extend your manufacturing capabilities.

icon-powder

Powder

Customized cell culture media and buffer powders are manufactured in Sartorius’ animal component-free facilities.

icon-dangerous-fluids

Strong Acids, Bases, Alcohols and Detergents

Sartorius produces high-quality custom acid/base and detergent solutions for downstream applications.

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

Consult an Expert

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

Consult an Expert

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.

Consult an Expert

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

  • Ready-to-use
  • Small scale
  • Flexible
  • Use of smaller amounts
  • Logistics with larger amounts are complex/costly
  • Limited ability to upscale
  • Requires a lot of storage space
  • Longer expiry dates
  • Larger scale/easy to upscale
  • Lower sensitivity to light exposure
  • Lower sensitivity to temperature excursion
  • Efficient logistics
  • Occupies less storage space
  • Media preparation takes time
  • High-quality water (e.g., WFI) is needed
  • Time-consuming when only small amounts are needed

Table 1: Advantages and disadvantages of liquid and powdered media.

Featured Assets

icon-blog

Science Snippets Blog

cGMP: What Every Life Science Researcher Should Know About Current Good Manufacturing Practice

Read Now

icon-webcast

Webinar

Media Management in an Intensified Process

Watch Now

Related Assets

Bioprocessing Media and Buffers - Grow With Us

PDF | 3.3 MB
Datasheet

From DSP Buffers to Dangerous Goods: One Single Source

PDF | 1.1 MB

Consult Our Experts

Consult Our Experts