BioSpectra, Inc.

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

Expertise in both microbial fermentation and chemical synthesis allows us to tackle today’s development pipeline’s increasingly complex molecules. In fact, we thrive on the vexing challenges few CDMOs would have either the expertise or desire to address. Bold vision, along with the passion and commitment to make that vision reality, is at the heart of our organization.

We are a forward-thinking, North American CDMO Pharmaceutical company specializing in clinical-to-commercial scale production capabilities for:

Synthetic small molecules
Fermented small molecules
Highly potent APIs
Biologics
Bioreagents

Flexibility, creativity, and dedication to process optimization are at the heart of our method and process development as well as quality and compliance efforts. We assure the programs advance on time and with the highest quality outcomes under our project managers’ leadership.

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

Founded in California in 2001, Acme's core mission is to support global customers as a true chemistry CRO alliance partner. We seek to make intellectual contributions in medicinal chemistry while providing exceptional synthetic chemistry service. We are committed to provide reliable services and deliver good quality products in a timely fashion.

Acme has about 130 chemists (15 PhD bench chemists in Palo Alto and 115 chemists at Shanghai). We also co-own a non-GMP manufacturing facility outside of Shanghai (from hundreds kilo grams to tons scale). We currently have a total of five scale up labs at Acme Shanghai site. We have reactors ranging from 10, 20, 50, and 100 L, and can handle temperatures from 150 oC to -78 oC. We can perform manufacturing projects and produce raw material for GMP.

Our US and China sites both have access to in house: NMR, LC-MS, Analytical and Prep HPLC, CombiFlash, Biotage Flash System, High-Pressure Reactor, Microwave Synthesizer, Photo Reactor, Polarimeter, Freeze-Dryer and more. We operate on a custom synthesis (FFS) or FTE equivalent model.