Clinical & Commercial Manufacturing
August Bio supports a wide range of cGMP manufacturing activities and programs,
container types and fill volumes, driven by deep commercialization expertise
in the sterile injectable space.
As a full-service provider, August Bio manages a diverse portfolio of client
projects ranging from small to large molecule, liquid to lyophilized products,
and both aseptic and terminally sterilized production processes.
Follow a manual added link
• Liquid fill
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill Sterile
Fill/Finish
Vials & Bottles 
• Aseptic or terminally sterilized
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing Sterile
Fill/Finish
IV Bags 
• Liquid fill
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill Sterile
Fill/Finish
Prefilled Syringes 
• Onsite cycle development
• Lab scale
• Controlled nucleation Lyophilization 
• Sterilization cycle development
• Air over pressure
• Saturated steam and validation Contract
Terminal
Sterilization 
• Temperature controlled shipments
• Bright stock depot services
• Flexible labeling services
• Track and trace Packaging,
Labeling
& Kitting 
• Controlled temperature storage and
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace distribution Clinical &
Commercial
Warehousing
& Distribution 
• Liquid & semi-solid formulation
• Laminate tube filling
• High pressure homogenization Non-Sterile
Manufacturing
Sterile
Fill/Finish
Vials & Bottles
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill
Fill/Finish
Vials & Bottles
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing
Fill/Finish
IV Bags
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill
Fill/Finish
Prefilled Syringes
• Lab scale
• Controlled nucleation
• Air over pressure
• Saturated steam
Terminal
Sterilization
• Bright stock depot services
• Flexible labeling services
• Track and trace
Labeling
& Kitting
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace
Commercial
Warehousing
& Distribution
• Laminate tube filling
• High pressure homogenization
Manufacturing
Follow a manual added link• Liquid fill
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill Sterile
Fill/Finish
Vials & Bottles • Aseptic or terminally sterilized
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing Sterile
Fill/Finish
IV Bags • Liquid fill
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill Sterile
Fill/Finish
Prefilled Syringes • Onsite cycle development
• Lab scale
• Controlled nucleation Lyophilization • Sterilization cycle development
• Air over pressure
• Saturated steam and validation Contract
Terminal
Sterilization • Temperature controlled shipments
• Bright stock depot services
• Flexible labeling services
• Track and trace Packaging,
Labeling
& Kitting Clinical &
Commercial
Warehousing
& Distribution • Controlled temperature storage and
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace distribution • Liquid & semi-solid formulation
• Laminate tube filling
• High pressure homogenization Non-Sterile
Manufacturing
Sterile
Fill/Finish
IV Bags
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill
Fill/Finish
Vials & Bottles
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing
Fill/Finish
IV Bags
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill
Fill/Finish
Prefilled Syringes
• Lab scale
• Controlled nucleation
• Air over pressure
• Saturated steam
Terminal
Sterilization
• Bright stock depot services
• Flexible labeling services
• Track and trace
Labeling
& Kitting
Commercial
Warehousing
& Distribution
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace
• Laminate tube filling
• High pressure homogenization
Manufacturing
Follow a manual added link• Liquid fill
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill Sterile
Fill/Finish
Vials & Bottles • Aseptic or terminally sterilized
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing Sterile
Fill/Finish
IV Bags • Liquid fill
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill Sterile
Fill/Finish
Prefilled Syringes • Onsite cycle development
• Lab scale
• Controlled nucleation Lyophilization • Sterilization cycle development
• Air over pressure
• Saturated steam and validation Contract
Terminal
Sterilization • Temperature controlled shipments
• Bright stock depot services
• Flexible labeling services
• Track and trace Packaging,
Labeling
& Kitting Clinical &
Commercial
Warehousing
& Distribution distribution • Controlled temperature storage and
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace • Liquid & semi-solid formulation
• Laminate tube filling
• High pressure homogenization Non-Sterile
Manufacturing
Sterile
Fill/Finish
Prefilled Syringes
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill
Fill/Finish
Vials & Bottles
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing
Fill/Finish
IV Bags
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill
Fill/Finish
Prefilled Syringes
• Lab scale
• Controlled nucleation
• Air over pressure
• Saturated steam
Terminal
Sterilization
• Bright stock depot services
• Flexible labeling services
• Track and trace
Labeling
& Kitting
Commercial
Warehousing
& Distribution
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace
• Laminate tube filling
• High pressure homogenization
Manufacturing
Follow a manual added link• Liquid fill
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill Sterile
Fill/Finish
Vials & Bottles • Aseptic or terminally sterilized
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing Sterile
Fill/Finish
IV Bags • Liquid fill
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill Sterile
Fill/Finish
Prefilled Syringes • Onsite cycle development
• Lab scale
• Controlled nucleation Lyophilization • Sterilization cycle development
• Air over pressure
• Saturated steam and validation Contract
Terminal
Sterilization • Temperature controlled shipments
• Bright stock depot services
• Flexible labeling services
• Track and trace Packaging,
Labeling
& Kitting Clinical &
Commercial
Warehousing
& Distribution • Controlled temperature storage and
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace distribution • Liquid & semi-solid formulation
• Laminate tube filling
• High pressure homogenization Non-Sterile
Manufacturing
Lyophilization
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill
Fill/Finish
Vials & Bottles
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing
Fill/Finish
IV Bags
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill
Fill/Finish
Prefilled Syringes
• Lab scale
• Controlled nucleation
• Air over pressure
• Saturated steam
Terminal
Sterilization
• Bright stock depot services
• Flexible labeling services
• Track and trace
Labeling
& Kitting
Commercial
Warehousing
& Distribution
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace
• Laminate tube filling
• High pressure homogenization
Manufacturing
Follow a manual added link• Liquid fill
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill Sterile
Fill/Finish
Vials & Bottles • Aseptic or terminally sterilized
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing Sterile
Fill/Finish
IV Bags • Liquid fill
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill Sterile
Fill/Finish
Prefilled Syringes • Onsite cycle development
• Lab scale
• Controlled nucleation Lyophilization • Sterilization cycle development
• Air over pressure
• Saturated steam and validation Contract
Terminal
Sterilization • Temperature controlled shipments
• Bright stock depot services
• Flexible labeling services
• Track and trace Packaging,
Labeling
& Kitting Clinical &
Commercial
Warehousing
& Distribution distribution • Controlled temperature storage and
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace • Liquid & semi-solid formulation
• Laminate tube filling
• High pressure homogenization Non-Sterile
Manufacturing
Contract
Terminal
Sterilization
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill
Fill/Finish
Vials & Bottles
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing
Fill/Finish
IV Bags
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill
Fill/Finish
Prefilled Syringes
• Lab scale
• Controlled nucleation
• Air over pressure
• Saturated steam
Terminal
Sterilization
• Bright stock depot services
• Flexible labeling services
• Track and trace
Labeling
& Kitting
Commercial
Warehousing
& Distribution
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace
• Laminate tube filling
• High pressure homogenization
Manufacturing
Follow a manual added link• Liquid fill
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill Sterile
Fill/Finish
Vials & Bottles • Aseptic or terminally sterilized
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing Sterile
Fill/Finish
IV Bags • Liquid fill
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill Sterile
Fill/Finish
Prefilled Syringes • Onsite cycle development
• Lab scale
• Controlled nucleation Lyophilization • Sterilization cycle development
• Air over pressure
• Saturated steam and validation Contract
Terminal
Sterilization • Temperature controlled shipments
• Bright stock depot services
• Flexible labeling services
• Track and trace Packaging,
Labeling
& Kitting Clinical &
Commercial
Warehousing
& Distribution • Controlled temperature storage and
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace distribution • Liquid & semi-solid formulation
• Laminate tube filling
• High pressure homogenization Non-Sterile
Manufacturing
Packaging,
Labeling &
Kitting
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill
Fill/Finish
Vials & Bottles
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing
Fill/Finish
IV Bags
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill
Fill/Finish
Prefilled Syringes
• Lab scale
• Controlled nucleation
• Air over pressure
• Saturated steam
Terminal
Sterilization
• Bright stock depot services
• Flexible labeling services
• Track and trace
Labeling
& Kitting
Commercial
Warehousing
& Distribution
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace
• Laminate tube filling
• High pressure homogenization
Manufacturing
Follow a manual added link• Liquid fill
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill Sterile
Fill/Finish
Vials & Bottles • Expertise in film selection and bag design
• 25 mL to 5 L fill
• Onsite analy• Aseptic or terminally sterilized
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testingtical testing
• Extractables and Leachables Testing Sterile
Fill/Finish
IV Bags • Liquid fill
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill Sterile
Fill/Finish
Prefilled Syringes • Onsite cycle development
• Lab scale
• Controlled nucleation Lyophilization • Sterilization cycle development
• Air over pressure
• Saturated steam and validation Contract
Terminal
Sterilization • Temperature controlled shipments
• Bright stock depot services
• Flexible labeling services
• Track and trace Packaging,
Labeling
& Kitting Clinical &
Commercial
Warehousing
& Distribution distribution • Controlled temperature storage and
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace • Liquid & semi-solid formulation
• Laminate tube filling
• High pressure homogenization Non-Sterile
Manufacturing
Clinical &
Commercial
Warehousing &
Distribution
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill
Fill/Finish
Vials & Bottles
• 25 mL to 5 L fill
• Onsite analy• Aseptic or terminally sterilized
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testingtical testing
• Extractables and Leachables Testing
Fill/Finish
IV Bags
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill
Fill/Finish
Prefilled Syringes
• Lab scale
• Controlled nucleation
• Air over pressure
• Saturated steam
Terminal
Sterilization
• Bright stock depot services
• Flexible labeling services
• Track and trace
Labeling
& Kitting
Commercial
Warehousing
& Distribution
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace
• Laminate tube filling
• High pressure homogenization
Manufacturing
Follow a manual added link• Liquid fill
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill Sterile
Fill/Finish
Vials & Bottles • Aseptic or terminally sterilized
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing Sterile
Fill/Finish
IV Bags • Liquid fill
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill Sterile
Fill/Finish
Prefilled Syringes • Onsite cycle development
• Lab scale
• Controlled nucleation Lyophilization • Sterilization cycle development
• Air over pressure
• Saturated steam and validation Contract
Terminal
Sterilization • Temperature controlled shipments
• Bright stock depot services
• Flexible labeling services
• Track and trace Packaging,
Labeling
& Kitting Clinical &
Commercial
Warehousing
& Distribution • Controlled temperature storage and
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace distribution • Liquid & semi-solid formulation
• Laminate tube filling
• High pressure homogenization Non-Sterile
Manufacturing
Non-Sterile
Manufacturing
• Lyophilization
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 500 mL fill
Fill/Finish
Vials & Bottles
• 25 mL to 2 L fill
• Expertise in film selection and bag design
• Onsite analytical testing
• Extractables and Leachables Testing
Fill/Finish
IV Bags
• Aseptic or terminally sterilized
• Glass or plastic
• .25 mL to 60 mL fill
Fill/Finish
Prefilled Syringes
• Lab scale
• Controlled nucleation
• Air over pressure
• Saturated steam
Terminal
Sterilization
• Bright stock depot services
• Flexible labeling services
• Track and trace
Labeling
& Kitting
Commercial
Warehousing
& Distribution
• Refrigerated storage
• 2-8 degrees Celsius
• -20 and -80 degrees Celsius
• Track and trace
• Laminate tube filling
• High pressure homogenization
Manufacturing
