Parenteral Drug & Injectable Processing Precision

Parenteral drug production is complex and costly and it requires a precision mindset. Pii's Aseptic Fill & Finish, Lyophilization, and Injectable experts can help improve the quality of the drug while reducing risks.

Parenteral Drug Formulation, Process Development & Fill-Finish

Injectable Drugs and Biologics

Pii enables biotech and pharmaceutical companies to accelerate timelines dramatically. Our proven capabilities include aseptic filling, terminal sterilization, lyophilization of biologic NCE, small molecule, potent (HPAPI) up to SafeBridge® Category 4, and cytotoxic drugs into vials, syringes, and cartridges.

Our focus is on accelerating decision-making at every step of the drug development process utilizing QbD to meet your project milestones, while also providing rapid access to manufacturing slots and quick release of drug product for clinical trial or commercial supply. All parenteral products are processed and tested in strict accordance with cGMP requirements. Our services include:

  • Sterile dosage forms
  • Lyophilized products
  • Suspensions and highly viscous liquids
  • Long-acting and depot injectables
  • Vials, syringes and cartridges
  • Drug device combination products

Learn more about Lyophilization Services

Formulation Dosage Types
aseptic filling screen view

Precision Injectable Drug Processing

The stakes are high! 100,000 doses of a modern parenteral drug formulation can cost millions. With patient populations whose lives depend on quality injectables delivered on time, there is simply no room for anything less than perfect.

Our skilled, experienced team of professionals employing the precision capabilities of Bosch filling systems will efficiently complete your project with efficiency, on time, and with the highest quality standards.

  • Completely integrated system from vial preparation to filling and capping
  • Flexible design for customized batch processes
  • Superb engineering for continuous production
  • Support both aqueous and non-aqueous formulations
  • Large batches with single-use compounding vessels up to 1,000 liters
  • Terminal Sterilization Option

Parenteral Drug Development and Manufacturing Expertise

Our skilled, experienced team of professionals employing the state-of-the-art GENiSYS R Aseptic Filling and Closure System will complete your project on time with the highest quality standards.

  • Fully robotic, automated lines that eliminate human intervention
  • Pre-qualified – no additional costs for media fill qualification
  • Customized statistical in-process controls (IPC) for complete, real-time batch records
  • Multiple container options – vials, syringes, cartridges
  • Accurate precision-filling that eliminates the loss of costly drug product
  • Pre-sterilized vials and syringes on-hand to support shortened timelines
  • Adaptable RABS – flexibly protecting your product and production workers
  • Continuous, non-destructive weight testing – no stoppages or wasted materials
  • Rapid production line change-over, up to 2 batches per day, accommodates multiple vials sizes, perfect for supporting Phase 1 clinical studies
Aseptic Filling Action

PARENTERAL DOSAGE FORMS

Vial for Parenteral Drugs

Vials

Injectable Suspension

Suspensions

Syringe for Parenteral Drug Dose

Syringes

Syringe Vial for Parenteral Drug Dose

Lyophilized Products

Talk to a Pii Scientist

See How Our Fully Robotic Machine Helps Your Phase I Study

GENiSYS

GENiSYS® R Small-batch, flexible
Aseptic Fill-Finish & Closing

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GENiSYS®R Robotic Aseptic Fill-Finish Video