DrugPatentWatch Pharmaceutical Drug Patent Intelligence

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

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

Agere is a global leader in bioavailability enhancement and cGMP services. Our comprehensive formulation design and development capabilities leverage Agere's Quadrant 2 solubilization formulation platform. Quadrant 2 empowers formulation development to efficiently explore a broader design space. Adhering to quality by design (QbD) guidelines de-risks results to achieve your target product profile.

All client services -- from formulation through clinical trials materials manufacturing -- are customized per API and done on a fee-for-service basis.

Formulation Development
• Formulation design and development
• Solubilization formulation expertise
• Innovative analytical technologies
• Materials science and characterization
• Computational modeling

cGMP Manufacturing
• Spray drying
• Tablets
• Capsules
• Inhalation powders
• Topical dosage forms

cGMP Analytical
• Full support for manufacturing and release testing
• Method development and transfer
• Method qualification/validation
• Full stability suite of services

EMAIL: info@agerepharma.com or careers@agerepharma.com

Ambio Pharmaceuticals is the parent company of AmbioPharm, Inc. and Ambio, Inc.

AmbioPharm was founded in 2005 and is headquartered in North Augusta, South Carolina, USA specializing in developing highly efficient manufacturing processes for peptide-based Active Pharmaceutical Ingredients (APIs) at very small to very large scales. In our manufacturing facilities in South Carolina, USA and Shanghai, China, we manufacture New Chemical Entities (NCEs) and generic peptide APIs under cGMP for clients worldwide. Both facilities have been inspected multiple times by the FDA with excellent outcomes.

Ambio is a drug development company with a rich and growing pipeline of proprietary drug development programs for bioequivalent and biosimilar versions of the world’s best-selling peptide drugs.

API MANUFACTURING:
Apertus manufactures active pharmaceutical ingredients (APIs) for companies that make finished dosage products and/or develop novel dose delivery systems and formulations. Our focus is providing bulk (Schedule II–V) controlled actives, however non-controlled APIs are also within our project portfolio.

ANALYTICAL SERVICES:
Apertus performs analytical methods development and services on a variety of instrument platforms. Our primary focus is LC (UV), LCMS and GCMS. We can use existing methods or develop novel methods on a per-project basis. In addition, we can provide methods validation, impurity identification and tech transfer packages.

PHARMACEUTICAL SERVICES:
Apertus provides services for drug discovery and preclinical development on a kilo-lab scale. We can supply intermediates, specialty chemical synthesis, process optimization and scale-up services. In addition we can aid in characterizing RLDs via dissolution profiles, chemical analysis and microscopy. All services can be provided under cGMP if desired.