Sterile Fill-Finish Services

Sterile Fill-Finish Drug Development & Manufacturing

Curia’s proven track record with liquid and lyophilized formulations demonstrates our ability to provide you start to finish development ensuring you maintain engagement and complete control during the entire project life-cycle.

Experts in ensuring your product maintains safety and efficacy

Curia’s multi-site capabilities approach ensures you maintain engagement and complete control during the entire project life-cycle

Formulation Development

Various formats for when you need them

Curia has the demonstrated ability to provide start-to-finish development in sterile fill-finish in various formats, including vials, pre-filled syringes and cartridges, and supports your program from IND through commercialization

MANUFACTURING

Embracing complexity worldwide

Curia works with complex APIs, including generics, sterile APIs, steroids, potent and cytotoxic compounds, and controlled substances – from clinical to commercial scale – at advanced facilities around the world

Our Approach is a Process, 
not a Platform

At each product development milestone, you can easily transfer into Curia, to advance and streamline the process.

Our Target Product Profile (TPP) covers:

  • Route of administration
  • Dosage concentration
  • Container closure system
  • Critical Quality Attributes
  • Critical Process Parameters
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Our Drug Product Site Network

Discover the power of our drug product network! Save time, cut costs, and seamlessly advance your product with our extensive site network.

Clinical Sterile Fill-Finish Locations

Bulk Capacity
0.5 – 100 L

GMP Dose Filling Lines
Vials, syringes & cartridges

Validated For
2 – 30 mL vials 1 – 2.25 mL syringes 1.5 mL cartridges

Non-cyto
Liquid and Lyophilized

Cyto/Highly Potent
No

Expertise and Capabilities

  • Formulation development (large and small molecule)
  • Analytical Development
  • High concentration formulation technology
  • Lyophilization cycle development and optimization
  • Aseptic processing
  • Microfluidization/high-shear homogenization/extrusion
  • Suspensions/emulsions/liposomal/nanoparticles
  • Small molecule
  • Proteins/peptides/oligonucleotides
  • Monoclonal antibodies (mAbs)
  • Inactivated and attenuated live virus
  • Clinical supply (Pre-clinical – Phase III)
  • Full In-house QC/Microbiology Services
  • Stability Services

Quality and Regulatory

  • FDA Registered Facility

Bulk Capacity
1 – 100 L

GMP Dose Filling Lines
Vials

Validated For
2 – 50 mL vials

Non-cyto
Liquid and lyophilized

Cyto/Highly Potent
Liquid and lyophilized

Expertise and Capabilities

  • Formulation development (large and small molecule)
  • Analytical Development
  • Lyophilization cycle development and optimization
  • Aseptic and Terminal Sterilization processes
  • Microfluidization/high-shear homogenization/microfluidics
  • Suspensions/emulsions/liposomal/nanoparticles
  • Small molecule
  • Proteins/peptides/oligonucleotides
  • Monoclonal antibodies (mAbs)/antibody drug conjugates (ADCs)
  • Inactivated and attenuated live virus
  • Clinical supply (Pre-clinical – Phase III)
  • Full in-house QC/Microbiology Services
    Stability Services

Quality and Regulatory

  • MHRA licensed
  • QP release
  • Home Office registered for Schedule I – V controlled substances

Commercial Sterile Fill-Finish Services Locations

Bulk Capacity
1-1200 L

GMP Dose Filling Lines
Vials, syringes & cartridges

Validated For
2 – 100 mL vials 1 – 10 mL syringes

Non-cyto
Liquid and lyophilized

Cyto/Highly Potent
Liquid and lyophilized

Expertise and Capabilities

  • Microfluidization/high-shear homogenization/extrusion
  • Suspensions/emulsions/liposomal/nanoparticles
  • Small molecule
  • Proteins/peptides/oligonucleotides
  • Monoclonal antibodies (mAbs)
  • Inactivated and attenuated live virus
  • Late phase clinical and commercial
  • Full in-house QC /Microbiology services (including sterility testing)
  • Stability Services

Quality and Regulatory

  • FDA and EU Approved
  • DEA registration for Schedule II-V controlled substances

Bulk Capacity
1 – 200 L

GMP Dose Filling Lines
Vials and syringes

Validated For
2 – 50 mL vials 1 – 10 mL syringes

Non-cyto
Liquid and lyophilized

Cyto/Highly Potent
Liquid

Expertise and Capabilities

  • Process Development
  • Highly viscous formulations
  • Microfluidization/high-shear homogenization/extrusion
  • Suspensions/emulsions/liposomal/nanoparticles
  • Small molecule
  • Proteins/peptides/oligonucleotides
  • Monoclonal antibodies (mAbs)
  • Clinical and commercial
  • In-house QC capabilities
  • Stability Services

Quality and Regulatory

  • FDA and EU Approved
  • DEA registration for Schedule II-V controlled substances

Ready to realize your product’s full potential on your schedule?