Apotex Pharmachem Inc.

Apotex Fermentation provides contract services in research, process development, scale up and cGMP manufacturing of fermentation based pharmaceutical products. We strive to develop robust and cost effective processes to help our customers achieve leadership positions in competitive pharmaceutical markets. We specialize in strain improvement and media development for secondary metabolites together with related downstream extraction, purification processes and CMC filings on time and on budget. We have the expertise and experience to take early stage lab scale processes through optimization and scale up to commercially viable validated processes producing product for clinical trials, formulation and final dosage forms.
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Locations


Canada
Apotex Fermentation Inc-Winnipeg
50 Scurfield Blvd
Winnipeg, MB  R3Y1G4
Canada, North America

GMP Experience
Experienced and knowledgeable Regulatory and Quality professionals at Apotex Fermentation have been very successful in guiding the company through General GMP and Pre-Approval Inspections by the U.S.

Contacts


Ted Hoare
Manager, Engineering & Project Management

Production Lines

Apotex Fermentation Inc-Winnipeg   1500L Pilot Scale
Location: Winnipeg, MB, Canada
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L1500L Bioreactor
GMP Level:  CommercialCommercial
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: 27JAN11

Send Inquiry about this Production Line
Apotex Fermentation Inc-Winnipeg   14,000L x3 Production Scale
Location: Winnipeg, MB, Canada
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  >5000L14000L Bioreactor
GMP Level:  CommercialCommercial
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: 27JAN11

Send Inquiry about this Production Line
Apotex Fermentation Inc-Winnipeg   30,000L x 2 Production Line
Location: Winnipeg, MB, Canada
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  >5000L30000L Bioreactor
GMP Level:  CommercialCommercial
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: 27JAN11

Send Inquiry about this Production Line

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