Small-scale Commercial Manufacturing - Sterile Products

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 product launch.

Commercial Services Include:

  • Final dosage form development and process Optimization
  • Tech transfer
  • Scale up and validation
  • Small scale commercial manufacturing (Batch Sizes from 1.0L – 300L)
  • Analytical testing, including microbial
  • Stability Studies
  • Potent and cytotoxic products
  • Controlled substances
  • Vials (2mL to 100mL)
  • Syringes (0.5mL to 20mL)
  • Lyophilized products
  • Ethanol-containing solutions
  • Suspensions

Pii can meet your needs at any stage of your sterile 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.