IriSys LLC

IriSys manufactures clinical supplies for all dosage forms and classes of drugs. We also have the capability to manufacture highly potent compounds. Our expertise is reflected by the renewal in 2015 of a five year contract with the National Cancer Institute (NCI)’s Developmental Therapeutic Program (DTP) of the Division of Cancer Treatment and Diagnosis (DCTD) for the pharmaceutical development and production of new therapeutic agents for use in clinical trials supported by NCI.

Under this agreement, IriSys will be supplying NCI with oral, topical and injectable dosage forms to be used in NCI-sponsored and/or investigator-initiated clinical trials in humans. IriSys will be responsible for formulation studies, process optimization, manufacture of the clinical dosage forms, release testing, quality control and quality assurance.

IriSys performs dosage form development for all phases of human clinical trials [I, II, III] in order to provide a wide variety of world-class pharmaceuticals, as well as commercial pharmaceutical products. Some of the medicinal products we manufacture include tablets and capsules, injectables, and gel, cream, and liquid dosage forms.

IriSys develops formulations for small molecules, proteins and peptides, as well as generics and 505b2 projects.

The Company develops the following dosage forms:

• Tablets
• Capsules, powder-filled
• Capsules, liquid-filled
• Oral solutions and suspensions
• Topical products
• Injectables
• Controlled release products
• Sustained release products
• Pellets
• Microspheres
• Lyophilized products
• Animal study materials

IriSys conducts preformulation development studies to determine the physical and chemical characteristics of the compound of interest, be it a small organic molecule, peptide, or protein. These studies generate the data that are a prerequisite to dosage form development and the data required for the Chemistry, Manufacturing and Controls (CMC) section of an Investigational New Drug application (IND). IriSys provides the following preformulation development studies:

• Pka and pI
• Partition coefficient and distribution coefficient as a function of pH
• pH-solubility profile
• Intrinsic solubility
• pH-stability profile at accelerated temperatures
• Accelerated stability studies
• Dissociation constants
• Hygroscopicity analysis
• Lipophilicity analysis
• Moisture analysis
• Excipient compatibility studies
• Salt formation characteristics determination
• Accelerated stability studies
• Viscosity analysis
• Disintegration studies
• Dissolution studies

IriSys’ team of analytical chemists is experienced in the development and validation of stability-indicating methods used to quantify drug substance purity and percentage of drug content in a dosage form, including impurities and degradation products. As each analytical method evolves, it is further used to measure conformity to dosage form specifications including dissolution, presence of related substances and product stability.

IriSys provides the following analytical chemistry services:

• Reference standard characterization
• Analytical methods development
• Stability-indicating method development
• Impurity profile generation
• Degradation product identification
• Analytical methods qualification
• Analytical methods validation
• Dissolution testing according to USP
• Dosage unit analysis for potency, purity and content uniformity
• Excipient testing
• Physical accelerated stress testing
• Chemical accelerated stress testing
• Specification development
• Chromatographic system development
• Identification of conditions required for optimal stability
• Container/closure testing and selection

Regulatory strategic planning

IriSys will create a regulatory plan that…

• Is based on your specific product and proposed application
• Includes 505(b)(2) strategy assessment
  • For sponsors relying upon clinical data or literature produced by other companies or entities
• Includes a risk assessment
• Considers your timeline and financial resources

Product development, processes or procedures evaluation with regard to regulatory compliance

IriSys will…

• Analyze the scientific basis and history of your product
• Determine further testing to fulfill regulatory requirements
• Conduct Preformulation Development Studies
• Conduct Dosage Form Development Activities
• Prepare Specialized Formulations as needed
• Provide world-class Analytical Chemistry and Preclinical Development Services

Pre-IND (Investigational New Drug application) meeting package preparation

IriSys will…

• Meet with you to prepare for a pre-IND Meeting with the FDA
• Prepare a Briefing Book that includes a rationale for recommended clinical studies
• Prepare your FDA Pre-IND Meeting Presentation

FDA pre-IND meeting participation

IriSys will…

• Accompany you to the Pre-IND Meeting
• Give your company presentation at the meeting
• Review the FDA feedback with you
• Provide advice for moving forward

CMC (Chemistry, Manufacturing and Controls) section of IND preparation

IriSys will be responsible for…

• Data generation
• CMC reports

IND application preparation & submission

IriSys will be responsible for…

• Preparation of your IND application
• Submission of the IND to the FDA

IriSys has been manufacturing commercial supplies of oral tablets and liquids since 2009. We currently have the capacity to produce up to one million tablet batches and 2000 liter liquids.