Specialty Commercial Manufacturing

Specialty pharma manufacturing and development

IRISYS’ expertise includes specialty commercial manufacturing of single source products and registration batches for Abbreviated New Drug Applications (ANDAs), formulations for rare diseases and orphan drugs. We have a successful track record with a wide range of therapeutic agents having varied physicochemical properties.

The FDA Orphan Drug Designation program provides orphan status to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of development and marketing. Given the limited financial opportunity it is especially important that orphan drug development, and rare disease drug manufacturing, be conducted as efficiently as possible.

Process improvement and validation, our services include:

  • Formulation and process optimization of drug product
  • Scale up from R&D to commercial cGMP batch manufacturing
  • Process validation
  • Technology transfer

Solid oral dosage forms and liquids, we manufacture pharmaceutical products in the following dosage forms:

  • Capsules, hard gelatin or HPMC (hydroxypropyl methyl cellulose), liquid-filled
  • Capsules, hard gelatin or HPMC, powder-filled
  • Capsules, controlled or sustained release
  • Tablets, immediate release
  • Tablets, controlled or sustained release
  • Tablets, enteric-coated
  • Topical gels, creams, ointments
  • Oral liquids
  • Over-encapsulation
  • Injectables, including lyophilization

For more information about our Orphan Drug Development and Specialty Commercial Manufacturing services, fill out the contact form below: