Miltenyi Bioprocess

At Miltenyi Bioprocess, our primary goals are customer satisfaction and product quality.

To accomplish this vision, our project teams take pride in listening carefully to our customers’ needs, in asking the right questions, and in identifying all important and critical parts of our customer's project.  To realize these tasks we have state-of-the-art development and production facilities that are in compliance with the actual regulatory guidelines.

Furthermore, our Bioprocess teams meet the highest standards in areas like development and API production, pharmaceutical production, QC, QA, and regulatory affairs.

Choose our outstanding proficiency for the success of your projects!
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Locations


Germany
Headquarter
Friedrich-Ebert-Str. 68
Bergisch Gladbach,   51429
Germany, Europe

GMP Experience
Manufacturing of GMP-compliant tools for cellular therapies based on magnetic beads
Germany
Teterow branch
Robert-Koch-Str. 1
Teterow, 17166
Germany, Europe

GMP Experience
Manufacturing of biologics with mammalian cells and aseptic fill & finish incl. lyophilization of injection vials

Contacts


Dr. Jens Stracke
Key Account Industrial Services

Production Lines

Teterow branch   Biologics (API)
Location: Teterow, 17166, Germany
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Process:  PerfusionPerfusion
BioReactor Scale:  100L-2000L200L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 1Biosafety Level 1
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is Not AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 22OCT09

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Teterow branch   Fill & Finish incl. Lyo
Location: Teterow, 17166, Germany
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LyophilizedLyophilized
Batch Size:  5,000-20,0005,000-20,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
GMP Level:  Phase IIIPhase III
Biosafety Level:  Biosafety Level 1Biosafety Level 1
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is Not AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 26OCT09

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