Sterile Product Development and Manufacturing
Pii offers fully integrated development services, CTM and small volume commercial manufacturing for liquid and lyophilized products in vials and syringes. Our aseptic facility in Maryland is an FDA-inspected and approved commercial manufacturing site.
Comprehensive capabilities include development of sterile liquid, suspensions, emulsions and lyophilized dosage forms. We also have the ability to handle potent and cytotoxic compounds and controlled substances (Schedules I-V). Product development services are complemented by full analytical, regulatory and project management support. Our expertise and capabilities are focused on rapid development to help you achieve your development goals, reduce costs and accelerate timelines.
Pii's Sterile Contract Manufacturing and Development Services include:
- Formulation development and process validation
- Analytical methods development and validation
- Analytical testing, including microbial
- Stability Studies
- Process optimizaiton
- Scale up to commerical production
- Small scale commercial manufacturing
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- Potent and cytotoxic products
- Controlled substances (Schedules I-V)
- Vials (2mL to 100mL)
- Syringes (0.5mL to 20mL)
- Lyophilized products
- Ethanol-containing solutions
- Suspensions
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Pii can meet your needs at any stage of your product's lifecycle, with fully integrated development services and commerical manunufacturing in one location.
Click here, for a list of Pii's aseptic manufacturing equipment capabilities.
Benefits & Advantages:
- Seamless supply from development to product launch for small volume commercial products.
- Integrated services including formulation development, clinical manufacturing, scale-up, validation and commercial manufacturing.
- Complete analytical and microbiology services, including method development, transfer, validation, and raw materials in-process, release and stability testing.
- Sixteen years of product development experience. With more than 400 development programs completed, Pii has an extensive track record working with difficult to formulate drug substances and complex manufacturing processes.
- Strict adherence to regulatory compliance standards. Aseptic facility inspected and approved by the FDA.