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Highest Manufacturing Quality Standards

Dual Global Manufacturing Sites ISO Certified Following cGMP Guidelines

Lonza | Sartorius manufacturing sites are currently engaged in the manufacture of over 1,500 products for pharmaceutical and biotechnology applications such as disease diagnosis, biomedical research, production of diagnostics and therapeutics, and quality control testing of pharmaceuticals and medical devices for the presence of bacterial contaminants. Manufacture of these products, specifically cell culture media, reagents, and buffers, follow the protocols and compliance specifications of the following industry regulations:

  • 21CFR820
  • ISO 9001: 2008 certified
  • ISO 13485: 2003 certified

Features & Benefits

Flexible and Scalable Solutions

Industry leader in batch size scalability► Liquid: 0.5 L to 10,000 L batch size; Powder: 7 kg to 7,000 kg batch size
Dual global manufacturing sites ► Assurance of supply
Lonza | Sartorius  ► Fit-for-purpose and ready to use solutions adding value to your processes
Wide range of primary and secondary packaging ► Answering your specific needs

USP Sterility

Tests are performed on representative samples using the membrane filtration procedure in accordance with the US Pharmacopoeia or EP Pharmacopoeia. Culture media used are fluid thioglycollate medium (FTM) and trypticase soy broth (TSB). All tested media must pass growth promotion testing before use. The test samples are filtered and the filters are immersed in FTM and TSB. TSB cultures are incubated at 22.5°C +/- 2.5°C. FTM cultures are incubated at 32.5°C +/- 2.5°C. The cultures are incubated for 14 days, during which they are periodically examined and sterility results are recorded.

Cell Growth Promotion

Media and supplements are tested for their growth promoting properties using primary, diploid, and heteroploid cell lines unless other cells are appropriate based on the product use. Results are obtained using the Lowry protein method or manual cell count to assess cell replication. Visual screening of cultures is also done to ensure characteristic cell morphology and lack of toxicity. Additional testing for toxicity, function and/or activity may also be conducted if one or more is required in the product release specifications.

Moisture Content

This is a powder specific test. We are committed to offering the same high quality powdered media as you have come to expect with our liquid media. We utilize a unique micronization manufacturing process, which produces powder in a controlled environment, guaranteeing maximum stability and minimum degradation due to chemical oxidation.

Cell Growth Promotion

Media and supplements are tested for their growth promoting properties using primary, diploid, and heteroploid cell lines unless other cells are appropriate based on the product use. Results are obtained using the Lowry protein method or manual cell count to assess cell replication. Visual screening of cultures is also done to ensure characteristic cell morphology and lack of toxicity. Additional testing for toxicity, function and/or activity may also be conducted if one or more is required in the product release specifications.

Endotoxin

Products are tested for endotoxin content using the Kinetic-QCL™ Assay. Test dilutions used are screened for inhibition and enhancement in the Kinetic-QCL™ Assay. Endotoxin levels for these products are available on Certificates of Analysis.

Shelf Life

Samples from each lot of standard product are retained and stored at label temperature in the event follow-up testing is required. Subsequent testing may be in response to your inquiry or for shelf life studies. Shelf life data is not included but is available for some products and upon request. Shelf life is generally between 6 and 24 months for liquid products and 24 months for powder products.

Release Testing & Documentation

Quality Control from Start to Finish for Each Product

Written procedures in accordance with current Good Manufacturing Practices (cGMPs) to verify the conformity of material to established specification throughout the manufacturing process, inspections and testings occur during the following four stages: Raw material receipt | In-process manufacturing, labeling and packaging | Finished product | Post-manufacture for shelf life studies.

 LiquidsPowders

Testing Options

SterilityStandardN/A
pHStandardN/A
OsmolarityStandardStandard
EndotoxinStandardN/A
Cell Growth PromotionStandard on CHO mediasN/A
MycoplasmaOn RequestN/A
MoistureN/AStandard
BioburdenN/AStandard
Shelf LifeOn RequestOn Request

Documentation

CofA and row material CoAStandardStandard


Quality Attributes Based on Application

Documented & Defined Protocols for Each Product

 

Attributes

Product for resarchNon-GMP ("Pilot") catalogue products and customProtein │ Vaccine production media for cGMP production
 

Product use

For research use onlyFor upstream │ downstream biopharma process developmentFor upstream │ downstream Biopharma clinical phase 3 or commercial production
Quality Assurance

QA System

ISO 9001

ISO 9001, ISO 13485

ISO 9001, ISO 13485 and cGMP 21CFR821

DHR-Device History Record

-

-

PI Sheet-Process Instruction Sheet (in SAP)

-

-

MSDS-Material Safety Data Sheet

CoA-Certificate of Analysis

TSE │ BSE statement

On request

CoO-Certificate of Origin

On request

Master Table-Theoretical data with all approved sources

-

On request

Batch Table-Production real data

-

On request

Specification sheet-Internal Testing References

N.A.

N.A.

-

Labels Request (from custom products)

N.A.

N.A.

CPR-Custom Product Request

N.A.

Change Notification

None

Systematic and proactive (timelines 6 weeks)

Systematic and proactive (timeless 6 weeks)

Quality ControlProduct Approval and ReleaseNo QA inspection of documentsAll products are released following an approved │ controlled an inspection of  all quality documents harmonized between both sitesAll products are released following an approved │ controlled QA inspection of all quality documents harmonized between both sites
Product Storage amd ShipmentShipment conditionsTheoretical shipment conditionsHarmonized shipping condition between sites supported by validation dataHarmonized shipping condition between sites supported by ASTM validation data

Handling of customer demands

Handling of Customer Quality AgreementsN.A.21 day Lonza Turnaround Time21 day Lonza Turnaround Time
Customer ComplaintsN.A.7 day Lonza Turnaround Time7 day Lonza Turnaround Time
Handling of Customer AuditsN.A.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 daysUpon 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

N.A.

Confidential information shared under CDA

Confidential information shared under CDA


Liquids

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

Powders

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

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


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