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Accelerate by Outsourcing Cell Culture Media & Buffers Production

Industry Leading Manufacturing Capabilities & Wide Array of Packaging Options

We offer liquid and powder media & buffers from small scale up to commercial scale. Our packaging solutions answer to your specific needs including bottles, single-use bags up to 1,000 L as well as drums for powders.

Liquids

With a comprehensive range of bottles, Flexsafe® and Flexboy® bags we can offer standard off-the-shelf or customized containment from 0.5 liters up to 1,000 liters per unit.

Powders

We offer a wide range of powder containers from 10g bottles up to several 100 kg. We also provide ready-to-use solutions such as media kits.

Dual Global Manufacturing Sites

 

Walkersville MD, USA

Verviers, Belgium

cGMP (21CFRB20) based manufacturing facility

ISO 9001:2008 certified

ISO 13485:2008 certified

Liquid media capabilities (per batch)

Up to 10,000 L

Up to 10,000 L*

Powder media capabilities (per batch) NAO Medium

Up to 700,000 L

Up to 100,000 L

Batch capacity

7-7290 Kg

20-1200 Kg

Dedicated support from both Sartorius and Lonza teams are assigned for each custom manufacturing project. Each project is treated with high confidentiality and matches customer requirements. Specific documentation is available to help our customers build a regulatory dossier.

* up to 4000 L in small bags or bottles for AO and NAO media and up to 10000 L in big bags (> 50 L size)


Clean and Fast Pilot Production

Quickly and Easily Validate Your Media or Buffer Formulation

Limited QC tests allow for faster timelines from production to delivery date. This pilot production approach allows for a simpler process for the testing and validation of any media or buffer formulation after it has been selected. This offer is the best option when it comes to the validation phase of a scaling-up a process.

 

Attributes

Non-GMP ("Pilot") catalogue products and custom

Quality Assurance

Product use

For upstream │ downstream biopharma process development

QA System

ISO 9001, ISO 13485

DHR-Device History Record

-

PI Sheet-Process Instruction Sheet (in SAP)

-

MSDS-Material Safety Data Sheet

CoA-Certificate of Analysis

TSE │ BSE statement

CoO-Certificate of Origin

Master Table-Theoretical data with all approved sources

On request

Batch Table-Production real data

On request

Specification sheet-Internal Testing References

N.A.

Labels Request (from custom products)

N.A.

CPR-Custom Product Request

Change Notification

Systematic and proactive (timelines 6 weeks)

Quality Control

Product Approval and Release

All products are released following an approved │ controlled an inspection of  all quality documents harmonized between both sites

Product Storage amd Shipment

Shipment conditions

Harmonized shipping condition between sites supported by validation data

Handling of customer demands

Handling of Customer Quality Agreements

21 day Lonza Turnaround Time

Customer Complaints

 7 day Lonza Turnaround Time

Handling of Customer Audits

 Upon receipt of customer's audit request Lonza │ Sartorius will respond with 3  potential dates all within a period of 3 months from request date -> Any  corrective action response required as an audit outcome, a receipt notofication  will be send within 5 open days and a corrective action plan (CAPA) is  expected to be answered within 60 days

Confidentiality

Confidential information shared under CDA

Batch Size

Liquid

Up to 100L

Powder

Up to 7kg


Packaging Solutions

Leveraging Sartorius and Lonza Strengths

We can assist in designing and providing the best products and offer packaging solutions answering to your specific needs. We want to protect our products in the best possible way with high-quality packaging – on the inside as well as the outside. We always place particular value on the highest standards of safety and security, in order to offer efficient and flexible solutions in a market that is both challenging and constantly changing.

Shipping Solutions for Media & Buffers

Liquid Form

  

0,5 to 1L

1 to 2,5L

2 to 20L

50L

100L

200L

500L

1000L

Bottle 

      
LDPE 2D Pillow Bag  

     
Drum    

  
LDPE 3D Bag in Container     

Stainless Steel Palletank     

Plastic Palletank      

 


Powder Form

  

10g to 2kg

5kg to 20kg

Bucket

 

 

Drum

  

 Applicable forMedia & BuffersMedia & Buffers


Dedicated Transport for Shipping

Ensuring Product Integrity From Manufacturing to Point of Use

Media & Buffer product storage and shipping conditions vary. While some can be stored at ambient temperature (uncontrolled), others might need to be stored at Room Temperature (15-30°C), Refrigerated Temperature (2-8°C) or Frozen Temperature (-10°C | -20°C). Appropriate packaging is provided to maintain optimal shipping conditions. We have years of experience in shipping small volumes as well as large volumes of our products (in liquid or powder form) at different temperatures all around the globe.


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