Alpha Biologics

 Alpha Biologics is an independent contract manufacturing organization, founded in 2003, specialising in mammalian cell-secreted proteins. Alpha Biologics offers US FDA/EU EMEA cGMP compliant services to the worldwide pharmaceutical and biotechnology industry. The facility, based in Penang, Malaysia also has process development/scale-up laboratories.
The Penang facility has the state-of-the art, bespoke processing equipment, monitored 24 hours by an internal Data Management System. The are seperate areas for analytical development, quality control and engineering functions.
Alpha is part of the Viropro group, offering full contract services from cell line development through to cGMP manufacturing.
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Locations


Malaysia
Alpha Biologics Manufacturing Facility
No.1056, Jalan Perindustrian Bukit Minyak 8
Kawasan Perindustrian Bukit Minyak
Simpang Ampat, Penang  14100
Malaysia, Asia

GMP Experience
Experienced expatriate staff with many years of cGMP in Europe, India and America. Facility compliant with US-FDA, EMEA and PIC/s guidelines. Will be undergoing PIC/s accreditation procedures Q3 2013.

Contacts


Michelle Peake
Chief Executive Officer

Production Lines

Alpha Biologics Manufacturing Facility   500L
Location: Simpang Ampat, Penang, Malaysia
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 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 Not AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 22NOV09

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Alpha Biologics Manufacturing Facility   250L #1
Location: Simpang Ampat, Penang, Malaysia
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 Not AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 22NOV09

Send Inquiry about this Production Line
Alpha Biologics Manufacturing Facility   250L #2
Location: Simpang Ampat, Penang, Malaysia
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 Not AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 22NOV09

Send Inquiry about this Production Line
Alpha Biologics Manufacturing Facility   70L
Location: Simpang Ampat, Penang, Malaysia
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:  1L-100L70L 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 Not AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 22NOV09

Send Inquiry about this Production Line

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