ChemWerth Inc.

CSBio is a leading peptide and peptide synthesizer manufacturing company located on the edge of Silicon Valley in Menlo Park, California. Since 1993, CSBio has been providing high quality custom peptides, cGMP peptides and automated peptide synthesizers to the global biotech community. Our peptide products and peptide synthesis equipment can be found in peptide production laboratories and pharmaceutical companies worldwide.

CSBio now also offers solid phase peptide synthesis resins as well as high quality Fmoc and Boc protected amino acids for use in both R&D and cGMP peptide manufacturing. Our state of the art cGMP manufacturing facility provides cGMP peptides for preclinical and clinical programs and our commercialization and regulatory teams can take you from toxicology studies through market commercialization. Our product line also includes a complete list of generic peptide APIs including the most widely used peptide APIs in the industry. Whatever your peptide requirements, CSBio can assist you in reaching your ultimate goals by offering high quality products and world class support.

Drug Discovery Alliances is a provider of chemistry and formulation services bringing together scientific expertise and support during all stages of the R&D continuum for emerging biotechs, existing multinationals and the United States government. We provide a global service where our partners – located in N. America, China, Japan, Czech Republic, England, Germany and Italy – cover four key services:

Consulting
• CMC Project Management
• GMP Auditing
• Licensing
• Sourcing & Procurement

Drug Discovery
• Medicinal Chemistry

R&D/Pre-Clinical
• Analytical Method Development
• Catalysis Screening
• Crystallization
• Metabolites, Impurities ID & Synthesis
• Process Research
• Reference Standards
• Solid Form Capabilities

Manufacturing (Phase I-III)
• Advanced Intermediate Manufacturing
• API & Commercial Manufacturing
• cGMP Manufacturing
• Final Drug Product Manufacturing
• Formulation Development
• Quality and Regulatory Support
• Raw Material Manufacturing

Chemistry Technology Platforms
Aseptic Fill & Finish
• Chlorination
• Chromatography
• Cryogenic
• Distillation
• Fermentation
• Heck Reactions
• HPAPI / High Potency
• High Pressure
• High Temperature
• High Throughput / High Resolution X-ray Diffraction
• Hydrogenation
• Lyophilization
• Nitration
• Pastillation
• Phosgenation
• Polymorph Screening
• Powder Filling
• X-ray Crystallography

Project Examples
• 4 year program for development of Regulatory Starting Material supporting NDA filing for a neurology product
• Urgent API consulting for Clinical Phase III with supplier change and identified savings of $10M
• CMC project consulting on pre-IND candidates ($760M) for a CNS product licensed by Astellas
• Generic new formulation consulting supporting Clinical Phase III for 505(b)(2) for hypertension product
• Commercial API manufacture for ophthalmology product sourcing key suppliers leading to successful FDA approval
• Phase III API for antibody conjugate for oncology identifying key supplier

Exela Pharma Sciences, a fast-growing specialty pharmaceutical company, focuses on developing, manufacturing and marketing generic and proprietary injectable and sterile ophthalmic products that keep the healthcare provider and patient in mind. Our goal is to deliver high quality, affordable products that make a difference in people’s lives, and also meet the needs of the healthcare providers that treat them.

Exela targets the development and manufacturing of generic and proprietary injectable and sterile ophthalmic products with high barriers to market entry, via an Abbreviated New Drug Approval or 505(b)(2) regulatory pathway. We develop products that enhance the patient or provider experience such as easing the burden of administration, providing an improved safety profile, faster drug perparation, or reduce drug waste. In other words, we strive to improve patient outcomes while reducing overall health care costs.

IRIX Pharmaceuticals, Inc. is a privately held company engaged in the generation of process technology for new and existing drugs.

IRIX offers the full capability of supplying API’s and complex pharma intermediates from pre-clinical stages, through all phases of clinical trials, registration/validation batches, launch and ongoing commercial quantities.

Formed to provide the Pharmaceutical Industry with a low-cost alternative for bringing new drugs to market rapidly, IRIX operates three sites for Process R&D and Clinical through Commercial cGMP production of API’s. Process R&D and early stage clinical supply for API’s is based in Florence, South Carolina. Late-stage clinical supply and commercial production is located in Greenville, South Carolina.

IRIX ensures compliance with all regulatory and quality requirements. Both the Greenville and Florence site were visited by the FDA in 2008 and 2009, respectively, with no 483s issued for either site.

IRIX supports new drug development in all functions necessary to bring a pharmaceutical candidate from discovery to market. IRIX provides seamless technology transfers both to/from Clients and internally for API syntheses.

The demonstrated expertise of the IRIX staff and the company’s emphasis on quality, economics, and timely delivery make it a choice CRMO (Contract Resources and Manufacturing Organization) for innovative pharmaceutical clients desiring to bring new drugs to the market rapidly.

Operating as an extension of the internal resources, IRIX offers sharp process solutions for an accelerated time to market at a very competitive cost.

Amarex is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services.

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