PII

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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:

  • Formulation development and process validation
  • Analytical methods development and validation
  • Analytical testing, including microbial
  • Stability Studies
  • Process optimization
  • Scale up to commercial production
  • Commercial manufacturing
  • Sterile liquids, suspensions, emulsions & lyophilized dosage forms
  • Ethanol-containing solutions
  • Potent and cytotoxic products
  • Controlled substances (Schedules I-V)
  • Vials (2mL to 100mL)
  • Syringes (0.5mL to 5mL)

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.

  • 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
  • With more than 16 years of product development experience  and 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. Our aseptic facility is inspected and approved by the FDA.

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