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 dramatically accelerate timelines. Our proven capabilities include aseptic filling, terminal sterilization and lyophilization of biologic NCE, small molecule, potent up (HPAPI) 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
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