Embed Size (px)
Citation preview
05/02/2023 IRISYS, LLC 2
Who We Are• Founded 1996 to focus on pharmaceutical science and industrial pharmacy• Highly qualified and experienced technical staff – over 20 Ph.D. and M.S.• Successful track record with therapeutic agents of all classes and physicochemical properties• Demonstrated expertise and compliance with cGMP regulations• State-of-the-art facility, FDA and FDB (CA) inspected in 2015 – no 483s• GMP commercial manufacturing experience and capacity
05/02/2023 IRISYS, LLC 3
From Preclinical to Commercial
Formulation Development
Analytical Methods Development
Regulatory and Drug Development
cGMP Clinical Supply Manufacturing
Commercial Manufacturing
05/02/2023 IRISYS, LLC 4
Why Clients Come to IriSysExperience and Breadth of Understanding• 150+ years of experience from discovery to commercialization• Scientists expert in their fields• Understand the value of meeting client timelines• Direct communication with scientists working on your project• Client focus accommodates change
05/02/2023 IRISYS, LLC 5
Wide Range of Clients,Partners and Collaborators
Domestic and International (Japan, China, Korea, Australia, Russia)
Small Biotech & Big Pharma
National Institutes of Health (NIH)• Therapeutics for Rare and Neglected Diseases (TRND)• National Center for Advancing Translational Sciences (NCATS)• Bridging Interventional Development Gaps (BrIDGs) Program• National Cancer Institute Developmental Therapeutic Program (DTP)
05/02/2023 IRISYS, LLC 6
Expertise that Distinguishes IriSys
Strong intellectual core• Extensive expertise in industrial pharmacy, drug discovery and development
Vision to understand the big picture• Consider both technical issues and their impact on the development program and regulatory
strategy
Expertise that covers the entire development path• Formulations, clinical manufacturing, FDA interactions, IND filings and clinical development
05/02/2023 IRISYS, LLC 7
Formulation R&DPre-formulation Studies
Analytical methods development, qualification and validation
Formulation development, all stages• Non-GLP animal studies• GLP Toxicology studies• cGMP NCE Phase I/II • Generic Drugs, 505b2
05/02/2023 IRISYS, LLC 8
cGMP Clinical Trials Manufacturing
Excipient Selection, Process Selection and Development
Dosage Forms• Tablets (immediate, extended and delayed release)• Liquid-filled capsules• Powder-filled capsules (immediate, extended and delayed release)• Oral liquids• Ointments, creams, gels• Injectables, including lyophilization
Volumes up to 10,000 units
05/02/2023 IRISYS, LLC 9
cGMP Clinical Trials Manufacturing
• Vials• Sterile fill syringes• Bottles• Over encapsulation• Blister packaging• Bulk packaging• Bulk labeling• Sachets• Powder in bottle
Packaging & Labeling
05/02/2023 IRISYS, LLC 10
Specialized Technologies for Formulation Development
• Moving from multiple daily doses to once daily• Controlled release of highly water soluble drugs• Immediate release of highly lipophilic drugs
Oral
• Increased bioavailability• Enhanced stability• Optimized viscosity• Optimized polymer network for high electrolyte content
Topical
05/02/2023 IRISYS, LLC 11
Specialized Technologies for Formulation Development
• Increased circulating half-life, optimized bio-distribution
• Improved safety and efficacy• Decreased immune recognition• Targeted delivery• Discriminative release (location and
environment)• Pharmacodynamically optimized formulations• Long-acting formulations
Parenteral
05/02/2023 IRISYS, LLC 12
Technologies
Proprietary Formulation Technologies
Lipid based formulations
Liquid-filled hard gelatin caps
Controlled release solid dosages
Micro and nanoparticles
Liposomes and solubilization
Formulations to enhance intellectual property portfolios
Small organic molecules
Peptides and biologics
Proteins
Synthetic polymers
Inorganic compounds
Cytotoxic and potent
Applications
05/02/2023 IRISYS, LLC 13
cGMP Commercial Manufacturing
FDA Inspected August 2015• Full commercial level inspection: no 483s• CA FDB inspected
Capabilities for oral tablets, capsules, liquids
Current Projects• Single source products• ANDAs• Rare disease and orphan drugs
05/02/2023 IRISYS, LLC 14
cGMP Commercial Manufacturing
Services• Formulation and process optimization of drug product• Scale up from R&D to commercial cGMP batch manufacturing• Process validation• Technology transfer
05/02/2023 IRISYS, LLC 15
Complete QC/QA ServicesQUALITY CONTROL
Analytical methods transfer and development
Release testing of bulk API and drug product
In-process testing
Microbiology
Certificates of Analysis
Stability study protocols and programs according to ICH Guidelines
QUALITY ASSURANCE
Protocol development, execution and review
Standard Operating Procedures
Manufacturing batch records
Specifications development
Final product release
Compliance audits
05/02/2023 IRISYS, LLC 16
Facility Layout
CLINICAL SUPPLIESDEVELOPMENT & MFG. COMMERCIAL
MFG.
OFFICES
QC
05/02/2023 IRISYS, LLC 17
Product Developmentand GMP Suites
1. Nanoparticle formulation
2. Tablet/powder compression
3. Blending, capsule filling – GMP processing of solid dosage forms
4. Formulation and analytical development
5. Nanoparticles, liposomes size analysis
6. Liquid filling
7. Formulation development – solid/liquid dosage forms
8. Analytical lab – HPLC, dissolution
9. Ointment/cream processing
10. Sterile lyophilization
11. Sterile processing, Class 100, Class 1000
05/02/2023 IRISYS, LLC 18
cGMP CommercialManufacturing Facility
05/02/2023 IRISYS, LLC 19
Drug Development &Regulatory Strategy
Drug development guidance at all stages
FDA strategic planning
Pre-IND FDA meetings• Meeting package and presentation prep• Meeting participation and follow-up
CMC sections and filing INDs• Data generation and reports• Preparation for submission
Organization and supervision of Phase I/II clinical trials
05/02/2023 IRISYS, LLC 20
Special Services forInternational Clients
Bring client’s products into the U.S.• Strategy and guidance throughout the U.S. FDA approval process• Meet at the client’s location or host representatives at IriSys• Provide translations• Educate client’s personnel about FDA regulatory requirements
05/02/2023 IRISYS, LLC 21
Leadership & ManagementGerald J. Yakatan, Ph.D., Founder, Chairman & CEO
Bob Giannini, Ph.D., Chief Scientific & Technical Officer
Louis Scotti, Vice President Business Development
Jean Wang, Ph.D., Vice President, QA & QC
Charlie Cavallino, Executive Director Manufacturing Operations
Brooke Yakatan, Director Quality Assurance and Regulatory Affairs
Igor Nikoulin, Ph.D., Director Research and Development
Kevin Xie, Controller
Victoria Smith Karpinski, Director HR and Administration
IRISYS, LLC05/02/2023 22
Thank You!
6828 Nancy Ridge Drive, Suite 100San Diego, CA 92121
P 858.623.1520F 858.623.1525www.irisys.com
