Sterile Fill-Finish Services

Sterile Fill-Finish

Supporting you from early stage development to commercial manufacturing, Curia’s proven sterile fill-finish track record with parenteral formulations demonstrates our ability to be your partner for the entire product life-cycle.

What sets Curia apart?

Curia’s network of drug product sites apply a bespoke approach with an emphasis on quality, safety, and efficacy, ensuring reliable product as you move from development to commercial manufacturing

  • End-to-end development in sterile fill-finish
  • Lyophilization expertise in all phases
  • Formulation and process development support
  • Capability and capacity in vials, pre-filled syringe, and cartridges
  • Handling of Controlled drugs (Schedule I to V)
  • Handling of HPAPI, Cyto/non-Cyto Small Molecule, and Biologics up to BSL2
  • Highly efficient and reliable internal/external technology transfer process

DRUG PRODUCT Development

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.

Modality agnostic, first principle formulation development designed around target product profile. Curia experts support the development of solutions, suspensions, emulsions, lipid nanoparticles, and lyophilized dosage forms. Addressing inherent complexities to provide robust, scalable products and processes for cGMP drug product manufacture.

DRUG PRODUCT MANUFACTURING

Various formats for when you need them

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

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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The Power Of Our Drug Product Network

Save time, cut costs, and seamlessly advance your product with our extensive network of sites and experts in aseptic processing. With Curia, you have a customized experience with a well-versed, dedicated program manager and team of subject matter experts from development through commercialization.

Clinical Development & 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 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
  • Sterile University

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


Your partner to address your Sterile Fill-Finish needs. Contact Curia today!