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Sterile Product Development
Pii offers fully integrated development services, CTM and small volume commercial manufacturing for sterile liquids and lyophilized products in vials and syringes. Our aseptic facility in Maryland is an FDA-inspected and approved commercial manufacturing site.
Our 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 in-depth 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:
Click here for a list of Pii’s aseptic manufacturing equipment capabilities.
Small Scale Commercial Manufacturing
Pii’s small scale filling lines offer an advantage to clients with niche and orphan drug candidates. When commercial volumes are forecasted to be low, smaller scale filling lines are more efficient and cost effective. Manufacture of your product using the same filling line eliminates the need for transfer, streamlines scale up, simplifies regulatory filings and provides a seamless supply from development through to product launch.
Benefits of Working with Pii:
Pii can meet your needs at any stage of your sterile product’s life cycle, with fully integrated development services and commercial manufacturing in one location.