Access Biologicals

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

PREMIUM PHARMACEUTICAL INGREDIENTS - MANUFACTURED EXCLUSIVELY IN THE USA
BioSpectra is a US Based manufacturer of GMP, pharmaceutical grade ingredients, including Actives, Excipients, GMP Process Chemicals & Bulk GMP Buffers and Solutions. Our focus is small molecule synthesis and true, phase change multi-step purification for both traditional and bio-pharmaceutical applications. Our services include Contract GMP product development coupled with ongoing commercial manufacturing and regulatory support up to and including DMF submissions. All of our manufacturing processes are fully validated. Our US-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Our onsite analytical testing capabilities include multi-compendial and custom specifications with full traceability and transparency of all raw materials and sources.

Our commitment is to quality, compliance and true, US-GMP manufacturing, testing and regulatory support is unparalleled. We own and operate out of 175,000 square feet of FDA registered & inspected GMP manufacturing space, under the most rigorous quality system while holding to the most stringent regulatory demands. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have.

GMP Product Categories:
• Bulk, GMP Biological Buffers
• Active & functional Excipients
• GMP Process Chemicals and Bulk GMP Solution Solutions

Custom GMP Services Include:
• Purification of Key Ingredients
• Full GMP Product Development
• Small Molecule Custom Synthesis
• API Development & Manufacturing
• Custom GMP Compounded Solvents & Solutions

Comprehensive Quality and Regulatory Program
• FDA Registered and Inspected
• Document Support - DMF Submissions
• Global GMP Requirements – US, IPEC, ICH Q7

Clara Diagnostics is developing the Exosome Sorting System (ExoSS), a high-throughput microfluidic system for the isolation and purification of exosomes. The company aims to launch the first microfluidic exosome sorting device (ExoSS) into the marketplace for automated, high-specificity, and high throughput preparation of exact exosome subtypes from a variety of biofluids.
The ExoSS system performs isolation 100x faster than ultracentrifugation and able to extract greater than 90% of exosomes with an isolation purity greater than 90%. ExoSS rapidly runs parallel samples continuously, resulting in a platform ideal for large volume processing. Designed for low skill automation, ExoSS has the advantage of extracting all or only specific
types of exosomes from the biological source.
An On Site Non-Clinical Isolation Service (ExoSS OnSite) was launched in November 2018 by the company utilizing the existing ExoSS system.
Clara Diagnostics is focused on establishing strategic partnerships for development in diagnostic and therapeutic applications, equipment manufacturing, antibody sourcing, distribution, sales and marketing.

HIGHLAND LABORATORIES is a UL NPA GMP Certified manufacturer of vitamins, supplements, and personal care products. For 50 years Highland has been innovating and collaborating with the best suppliers, developing long term relationships with the best growers and manufacturers to ensure only the very highest quality of ingredients find their way into our products.

In January 2017, we earned our Organic Certification through Oregon Tilth and can now produce both conventional and organic vitamins and supplements, as well as personal care products containing organic ingredients.

We continue to place the highest value on quality, integrity and on establishing a real, human connection between our staff and yours.

What Makes Us A World-Class Manufacturer:
NPA accreditation for our Good Manufacturing Practices (GMP)
Certified Organic through Oregon Tilth
Innovative products and custom-made formulations
Analytical and microbiological laboratories on site
A very stringent Quality Assurance program—for raw materials and vendors
Contract manufacturing for nationally recognized products
Highly qualified and accessible staff of professionals
In-house Design, Printing, Marketing and Technical Assistance at your service.

Accelerated Enrollment Solutions (AES) helps biopharmaceutical companies overcome patient recruitment and research site challenges to deliver greater speed, certainty, and control to clinical trial delivery.

Through the combination of a powerful patient recruiting solution and more than 160 owned and partnered clinical research sites throughout the world, AES provides a single global source for clinical trial sites and patients that delivers centralized control, consistent operations and quality worldwide, and more patients from fewer sites in less time.

AES is a business of PPD, a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.

For more information, visit www.globalAES.com.