Specialty Commercial Manufacturing

Specialty pharma manufacturing and development

IRISYS, LLC commercially manufactures tablets, capsules, liquids, gels, and injectables in a cGMP facility.

IRISYS has a diverse 24,500 sq. ft manufacturing facility that provides clients with a broad range of manufacturing tools to accomplish even the most challenging projects.

“As your company grows and moves through the various stages of manufacturing IRISYS can be there to support your team.”

How do you know what form of manufacturing is best for your pharmaceutical-grade formulation? IRISYS goes through an in-depth process of evaluation and validation. The evaluation process is an important step in determining the best form to administer your pharmaceutical drug.

Our Process of formulation improvement and validation includes:

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

Once the dosage form is decided on IRISYS has specialized technology to accomplish manufacturing on site.

Oral Solid Tablets, Liquid-Filled Hard Gelatin Capsules

Multiple-dose to single daily dose

Controlled release of highly water-soluble drugs

Immediate release of lipophilic drugs

Topicals, Gels

Increased bioavailability

Enhanced stability

Optimized Viscosity

Optimized network for high electrolyte content

Parenteral Injectables, Intramuscular, Subcutaneous and Intravenous

Increased circulating half-life, optimized biodistribution

Improved safety and efficacy

Pharmacodynamically optimized formulations

Long-acting formulations

We manufacture pharmaceutical products in the following dosage forms:

  • Capsules, hard gelatin or HPMC (hydroxypropyl methylcellulose), 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

“Our clients have found that our hands-on approach to solving their complex problems while leading them through the manufacturing process was invaluable to delivering their drugs to market.”

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: