Rentschler Biotechnologie GmbH

Rentschler is a biopharmaceutical manufacturer with over 40 years proven track record. As an independent and privately-owned company headquartered in Germany our full-service customized solutions range from supporting drug candidate selection by our TurboCell plattform, as well as cell line and process development over production to analytics and fill & finish.
Focused on mammalian cell lines, our experience covers the development, production and aseptic filling of recombinant proteins such as cytokines, enzymes, monoclonal antibodies and fusion proteins in compliance with international GMP standards (EMA/FDA). We don't just claim to be reliable and experienced. Our many successful projects and long lasting client relationship show that we are.
State-of-the-art facilities and services comprising batch, fed-batch and perfusion processes allow the production of material for clinical phases and commercial supplies. GMP certified suites with stainless steel bioreactors up to 3,000 L ensuring the flexible and customized production and delivery of material. As a cost-efficient and fast manufacturing alternative, Rentschler provides also single-use bioreactors with volumes of up to 2,000 L. Our Fill & Finish facility offers the aseptic liquid filling in vials (100 up to 80,000 units), lyophilization (100 up to 70,000 units) and aseptic liquid filling of prefilled syringes (100 to 15,000 units).
Our experience with international regulatory affairs and authorities increases the success rate for approval. This reduces not only the time-to-market but supports the success of your project. in summary, our full-service concept allows us to react with flexibility on the scope of services our clients need. 

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Locations


Germany
Rentschler Biotechnologie GmbH
Erwin-Rentschler-Stra├če 21
Laupheim,   88471
Germany, Europe

Contacts


Marion Schrader
Senior Director Marketing
Christoph Winterhalter
Vice President Business Development

Production Lines

Rentschler Biotechnologie GmbH   1,000 L Single Use
Location: Laupheim, 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-2000L1000L Bioreactor
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 27NOV14

Send Inquiry about this Production Line
Rentschler Biotechnologie GmbH   1,000 L Single Use
Location: Laupheim, 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-2000L1000L Bioreactor
GMP Level:  Phase IIIPhase III
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 27NOV14

Send Inquiry about this Production Line
Rentschler Biotechnologie GmbH   250 L Stainless Steel
Location: Laupheim, 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-2000L250L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 07DEC12

Send Inquiry about this Production Line
Rentschler Biotechnologie GmbH   500 L Stainless Steel
Location: Laupheim, 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-2000L500L Bioreactor
GMP Level:  Phase IIIPhase III
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 07DEC12

Send Inquiry about this Production Line
Rentschler Biotechnologie GmbH   1,000 L Single Use
Location: Laupheim, 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-2000L1000L Bioreactor
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 26NOV14

Send Inquiry about this Production Line
Rentschler Biotechnologie GmbH   Fill and Finish Vials
Location: Laupheim, Germany
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  50,000+50,000+
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
Supported Vial Size:  20+ ml20+ ml
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 07DEC12

Send Inquiry about this Production Line
Rentschler Biotechnologie GmbH   Fill and Finish Vials
Location: Laupheim, Germany
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LyophilizedLyophilized
Batch Size:  50,000+50,000+
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
Supported Vial Size:  20+ ml20+ ml
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 07DEC12

Send Inquiry about this Production Line
Rentschler Biotechnologie GmbH   Fill and Finish Prefilled Syringes
Location: Laupheim, Germany
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  5,000-20,0005,000-20,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Additional Services
Analytical Services are AvailableAnalytical Services
Formulation Development is AvailableFormulation Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Stability Studies are AvailableStability Studies
Prefilled Syringes are AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 26NOV14

Send Inquiry about this Production Line
Rentschler Biotechnologie GmbH   3,000 L Stainless Steel
Location: Laupheim, 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:  2000L-5000L3000L Bioreactor
GMP Level:  CommercialCommercial
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 20NOV14

Send Inquiry about this Production Line
Rentschler Biotechnologie GmbH   500 L Stainless Steel
Location: Laupheim, 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-2000L500L Bioreactor
GMP Level:  Phase IIIPhase III
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 26NOV14

Send Inquiry about this Production Line
Rentschler Biotechnologie GmbH   2,000 L Single Use
Location: Laupheim, 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-2000L2000L Bioreactor
GMP Level:  Phase IIIPhase III
Biosafety Level:  Not SpecifiedNot Specified
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 27NOV14

Send Inquiry about this Production Line

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