BoroChem PBO

Aurora Fine Chemicals is a privately held company that was founded in 1990. As a chemicals R&D supplier we offer chemicals for R&D, drug discovery service, compound libraries and custom synthesis. We have one of the largest collections of 18.1 mln. chemicals available in stock and our docking software delivers hits/leads of very high quality in short time.

Our staff consists of highly qualified individuals with Bsc, Msc and Ph.D. degrees in chemistry, as well as excellent laboratory technicians. In our Molecular Modeling Group are professionals specializing in computational drug design. They possess many years experience of working in the chemistry of heterocycles, carbohydrates, nucleosides and elemental organic compounds. Aurora has significant expertise in synthesis of all types R&D chemicals for drug discovery like small molecules, natural products and peptides. Parallel synthesis with well-designed, targeted and fragment-based libraries is the favored approach to lead optimization. Rational design is the strategy for projects driven by structural biology, such as enzyme inhibitors or protein interactions.

We own a large library of 18.1 million stocked compounds for R&D. Our substances are used in many research labs all over the world. We offer structures for biochemical and chemical research. Our products are applied in pharmaceutical development, diagnosis, and in chemical production.

Several laboratories for synthesis with modern equipment such as reactors, autoclaves, thermostats and hydrogenation equipment are available.

Intermediates and final products are analyzed by GC, HPLC, IR, NMR, MS, elemental analysis, atom-absorption analysis and crystallographical methods.

The main advantage of Aurora's own software is the quality of the underlying physical models. Aurora's software derives molecular properties from first principles based on direct models using advanced quantum mechanical analysis of molecular interactions and thermodynamics.

Welcome to Advanced Organic Synthesis (AO Synthesis; AOS). We are a manufacturer and supplier of fine chemicals, building blocks, polymers, pharmaceutical intermediates and many more specialized organic compounds.

We also are available for contract research and process development. Providing custom synthesis to our global customers.

We are dedicated to bring high quality and cost effective products on a timely basis.

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

Integrated Drug Discovery and Development Services
Our integrated offering allows clients to access multiple outsourcing choices across the research and development value chain. We offer the following services

Analytical Services
Method Development & Validation
Extractables & Leachables
Syringability, Injectability, & Inhalation Study
Manufacturer Validation
Raw Material Qualification
ICH Stability & Release Testing
Impurity Analysis & Contaminant Identification
Pre-Clinical, Clinical, & Post-Approval


Pre-Formulation & Formulation

Formulation Optimization
Solid Stage Characterization
IND & NDA Submission Support
Counterfeit Analysis
Degradation Analysis
API Analysis
USP Monograph Testing
Dissolution Studies
Overcoming Solubility Issues
Toxicology Analysis
Clinical Trial Material Manufacturing
Excipient Base Identification
Bioequivalence Analysis
Disintegration Studies

Custom Synthesis
Process R&D

Chemistry R&D and Custom Synthesis
The HDH Pharma scientific team has earned its reputation through its problem solving skills and out of the box thinking when coping with challenging chemistry.
Reaction Optimization
Synthetic route development
Feasibility analysis of synthetic pathways
Methodology studies for process development
Exploratory studies for original compound synthesis

Custom Synthesis Services:
Impurities
Building Blocks
Reference Compounds
Reaction Intermediates
Pharmaceutical Reference Standards

Building blocks and screening compounds Including:
4, 5, 6, and 7– membered heterocycles, fused heterocycles
Lipids, Carbohydrates, and Nucleosides
Pyridines, Pyrimidines, Purines, Substituted Benzenes, Pyrazoles, Osoxazoles, Oxadiazoles, Indoles and Benzimidazoles
Aza-benzimidazoles, and Azitidine, Pyrrolidine, Piperidine

Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 11,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.

Pharmaron is a contract research organization (CRO).

Services:
* Synthetic, medicinal and analytical chemistry services
* Biology services
* DMPK services
* Pharmacology services
* Drug safety assessment services
* Radiochemistry and isotopically labelled metabolism services
* Chemical & pharmaceutical development services
* Clinical development services

www.pharmaron.com

CRO - Contract Research Organization
Library Synthesis
CADD
Bioorganic Chemistry
Discovery Process Chemistry
Radiolabelled Chemical Synthesis
ChemInformatics
in vitro Biology
in vitro Screening
Structural Biology
in vivo Pharmacology
Animal Disease Models
ex vivo Pharmacology
Biomarkers
in vitro ADME
in vivo PK
PKPD
QA
Regulatory Affairs
Discovery Biologics
Process Chemistry
API Manufacturing
Material Science
Formulation Development
Drug Product Manufacturing
Toxicology
Safety Pharmacology
Genetic Toxicology
DART
Pathology
Immunotoxicity
Bioanalytical
14C / Carbon-14 Radiosynthesis
3H / Tritium Radiosynthesis
QWBA
mARG
Clinical AME
Mass Balance
Metabolite Profiling
Microdosing Phase 0
Absolute Bioavailability
DDI
First-in-Human (FIH)
Thorough QT(TQT)
Ethnobridging