Goodwin Biotechnology Inc.

Goodwin Biotechnology, Inc., based in Plantation, Florida, is the earliest established and one of the most experienced and stable contract manufacturing organizations(CMOs) serving the biopharmaceutical industry.  Originally spun out of the Goodwin Institute for Cancer Research in 1992, our focus is to manufacture pre-clinical and early phase clinical trial materials and we understand our clients'requirements for quality, time and costs.  In the biologics CMO niche, Goodwin was the first to engineer the concept of "full integration", which enables us to work with our clients from the initial production step of developing the genetically engineered "production" cell line all the way through vialing of the final biopharmaceutical product and distribution to clinical trial sites.  Goodwin has an enviable reputation for regulatory compliance and has made dozens of clinical trial lots for more than 100 companies through its history. 

The senior operational and quality staff at Goodwin have decades of experience in GMP manufacturing. This experience includes work at several leading biopharmaceutical companies. Clients have the assurance of knowing that theindividuals entrusted with the manufacture of their products are seasoned industry professionals with excellent track records.

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Locations


United States
Plantation, FL
1850 N.W. 69th Avenue
Plantation, FL  33313
United States, North America

Contacts


Muctarr Sesay, PhD
Chief Scientific Officer and VP, Bioconjuction
SooYoung Lee, PhD
COO
Kayla Harris
Business Development Associate

Production Lines

Plantation, FL   Stirred Tank
Location: Plantation, FL, 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:  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: Available

Last Update: 26JUN14

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Plantation, FL   WAVE
Location: Plantation, FL, 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 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: Available

Last Update: 20OCT09

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Plantation, FL   Perfusion
Location: Plantation, FL, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  PerfusionPerfusion
BioReactor Scale:  1L-100L14L 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: Available

Last Update: 20OCT09

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Plantation, FL   Fill Finish
Location: Plantation, FL, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  1-5,0001-5,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
GMP Level:  Phase IIIPhase III
Biosafety Level:  Not SpecifiedNot Specified
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: 26JUN14

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Plantation, FL   Hollow Fiber
Location: Plantation, FL, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  PerfusionPerfusion
BioReactor Scale:  1L-100L4L 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: 20OCT09

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Plantation, FL   200L Stirred Tank
Location: Plantation, FL, 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:  100L-2000L200L 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: Available

Last Update: 19JAN11

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Plantation, FL   500L Bioreactor
Location: Plantation, FL, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  1-5,0001-5,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  3 ml3 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
GMP Level:  Phase IIIPhase III
Biosafety Level:  Biosafety Level 1Biosafety Level 1
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: 26JUN14

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