bioWORLD

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

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

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Applied Biological Materials (abm) provides quality research reagents and custom services at incredible prices. We have an extensive product range to make abm your one-stop supplier for all your research needs: PCR, RT-PCR, qPCR, antibodies, siRNA, miRNA, CRISPR, stable cell lines, immortalized cell lines, growth factors, and various viral expression systems (adenovirus, lentivirus, AAV). If you can’t find what you need, please let us know; our R&D team will tailor to your needs. We also provide custom services for the more challenging or time-consuming parts of your research projects. Custom recombinant adenovirus, custom lentivirus, custom cloning, gene synthesis, protein production and sequencing services are a few examples of abm’s assortment of services available to you. Conducting research shouldn’t cost you a fortune! abm is here to help!

Please contact us for more information on any of our products and available services.

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

Princeton Separations, Inc. (PSI) is a privately-owned, manufacturing-based biotechnology company specializing in molecular separations. PSI manufactures various successful products including:

Whether you need Centri·SepTM, Centri·Sep 8TM, and Centri·Sep 96TM for dye terminator removal from DNA sequencing reactions; Centri·SpinTM products for cleanup of molecular labeling reactions from nucleic acids, proteins or carbohydrates; PCR·96TM for probe and nucleotide cleanup of PCR reactions; BAC and Big BAC preparation in gene mapping, molecular cytometry and cell imaging; Modified Sequencing Grade Endopeptidases for protein sequencing and 5 BMT activator for chemical DNA\RNA synthesis; Fluoro·SpinTM labeling and purification kits for generation and purification of fluorescent probes for proteomics and drug discovery; or Pro·Spin product line for antibody purification, we have the answer for you when it comes to molecular separations!

PSI is a registered manufacturer with the FDA and the DEA. It maintains GMP (Good Manufacturing Practice) production in a growing facility in Freehold, New Jersey, where it performs sterile manufacturing for pharmaceutical/diagnostic companies.