Althea Technologies, Inc

Based in San Diego, California, Althea Technologies Inc. is a fully-integrated contract development and manufacturing organization with the experience, flexibility, and expertise to provide our clients with a reliable product supply as they move through the clinic and onto the market.  Founded in 1998, Althea has grown to over 180 employees encompassing four buildings at the San Diego, CA campus and a protein analytical laboratory in Camarillo, CA.  The San Diego campus has both clinical and commercial manufacturing facilities, which specialize in recombinant protein and DNA plasmid manufacturing in microbial expressions systems, and fill & finish manufacturing in vials and syringes.  In support of the core manufacturing capabilities, Althea also has tremendous expertise in process, analytical, and formulation development.  This level of integration and scalability positions Althea as a true strategic development and manufacturing partner for biopharmaceutical and injectable drug developers.

Althea is proud to boast a spotless FDA inspection history and very robust and successful track record of consistently delivering quality product to our clients.  We enjoy a very close working relationship with our clients and understand the uniqueness of each and every project.  We invite you to visit our website as an introduction to how we can support your development and manufacturing needs.

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Locations


United States
San Diego, CA
11040 Roselle Street
San Diego, CA  92121-1205
United States, North America

GMP Experience
Our facility has been specifically designed for maximum regulatory compliance and it has been inspected twice by the FDA with no 483 observations issued.
United States

Camarillo, CA
United States, North America

Contacts


Helen Liu
Market Development Associate

Production Lines

San Diego, CA   San Diego Microbial #1
Location: San Diego, CA, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L30L 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: 02JUN10

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San Diego, CA   San Diego Microbial #2
Location: San Diego, CA, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L100L 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: 02JUN10

Send Inquiry about this Production Line
San Diego, CA   San Diego Microbial #3
Location: San Diego, CA, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L100L 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: 09OCT09

Send Inquiry about this Production Line
San Diego, CA   San Diego Microbial #4
Location: San Diego, CA, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
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: 09OCT09

Send Inquiry about this Production Line
San Diego, CA   San Diego Fill/Finish #1
Location: San Diego, CA, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  20,000-50,00020,000-50,000
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:  Phase IIIPhase III
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 Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 02JUN10

Send Inquiry about this Production Line
San Diego, CA   San Diego Fill/Finish #2
Location: San Diego, CA, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  20,000-50,00020,000-50,000
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:  Phase IIIPhase III
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 Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 02JUN10

Send Inquiry about this Production Line
San Diego, CA   San Diego Fill/Finish #3
Location: San Diego, CA, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  20,000-50,00020,000-50,000
GMP Level:  Phase IIIPhase III
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: 02JUN10

Send Inquiry about this Production Line
San Diego, CA   San Diego Fill/Finish #4
Location: San Diego, CA, United States
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:  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:  Phase IIIPhase III
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 Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 09OCT09

Send Inquiry about this Production Line
San Diego, CA   San Diego Fill/Finish #5
Location: San Diego, CA, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  20,000-50,00020,000-50,000
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 Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 02JUN10

Send Inquiry about this Production Line
San Diego, CA   San Diego Fill/Finish #6
Location: San Diego, CA, United States
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 Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 02JUN10

Send Inquiry about this Production Line

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