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Toxikon is a preclinical contract research organization (CRO). We ...

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Corporate Overview<br />

<strong>Toxikon</strong> At A Glance<br />

Services<br />

Capabilities<br />

»»<br />

In Vivo Services<br />

»»<br />

In Vitro Services<br />

»»<br />

Analytical/Bioanalytical<br />

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Support and Specialty<br />

Programs<br />

Locations:<br />

Corporate Headquarters<br />

<strong>Toxikon</strong> Corporation<br />

15 Wiggins Avenue<br />

Bedford, MA 01730<br />

800.458.4141<br />

info@toxikon.com<br />

www.toxikon.com<br />

<strong>Toxikon</strong> Europe N.V.<br />

Romeinsestraat 12<br />

B-3001 Leuven<br />

Belgium<br />

+32.16.400484<br />

info@toxikon.be<br />

www.toxikon.be<br />

<strong>Toxikon</strong> <strong>is</strong> a <strong>preclinical</strong> <strong>contract</strong> <strong>research</strong> <strong>organization</strong><br />

(<strong>CRO</strong>). <strong>We</strong> <strong>contract</strong> and partner with biotech,<br />

pharmaceutical and medical device industries to deliver<br />

exceptional product development services from concept to<br />

final product.<br />

No matter what your development needs, you can rely on <strong>Toxikon</strong> to be a flexible partner<br />

with technical <strong>research</strong> and development expert<strong>is</strong>e to meet your project goals<br />

for timely market launch.<br />

<strong>We</strong> not only provide you with excellent service, we also work closely and collaborate<br />

with you so that we understand your needs to develop a comprehensive testing program<br />

well aligned to meet your development objectives. As a leading <strong>preclinical</strong> <strong>CRO</strong>, <strong>Toxikon</strong><br />

has the experience and <strong>is</strong> a proven life science leader with a staff of scientific d<strong>is</strong>tinction<br />

who can provide in vivo, in vitro, analytical, and a host of other services central to the<br />

development of products designed to improve the quality of life.<br />

With <strong>Toxikon</strong> you gain a strategic and responsive scientific partner, who not only brings<br />

reliability, trust, and flexibility to your projects, but also the assurance to align with your<br />

corporate goals, achieve product safety and regulatory compliance, and maintain the<br />

highest levels of environmental and manufacturing quality control.<br />

Whether you are a pharmaceutical, medical device or biotech company, collaborating<br />

with <strong>Toxikon</strong> provides you access to a team of experts experienced in a comprehensive<br />

range of compound structures, therapeutic targets as well as medical devices and<br />

combination products.<br />

A Resourceful <strong>CRO</strong><br />

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<strong>Toxikon</strong>’s Massachusetts campus, located in the heart of Bay State’s life science<br />

<strong>research</strong> hub, has more than 125,000 square feet of facility space dedicated to the<br />

development of compounds, biologics, and medical devices;<br />

»»<br />

<strong>Toxikon</strong> Europe operates a 14,000-square-foot facility in Leuven,<br />

Belgium, to meet the needs of European pharmaceutical, biotech<br />

and medical device industries;<br />

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An experienced international team;<br />

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A highly educated and trained workforce;<br />

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Broad technical expert<strong>is</strong>e with recognized scientific excellence;<br />

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World-class facilities in the United States and Europe;<br />

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Client/Sponsor-centric;<br />

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Collaborative and <strong>research</strong>-oriented culture.<br />

www.toxikon.com


Corporate Overview<br />

Services at a Glance<br />

<strong>Toxikon</strong> <strong>is</strong> an ISO/IEC 17025-accredited Contract Research Organization (<strong>CRO</strong>) reg<strong>is</strong>tered with the FDA for drug,<br />

biologics, and medical device testing. With approximately 200 employees, <strong>Toxikon</strong> <strong>is</strong> committed to staying at the<br />

forefront of life science technology development. <strong>Toxikon</strong>’s safety services include toxicology (acute, subchronic,<br />

and chronic toxicity, reproductive toxicity, genetic toxicology, carcinogenicity), pharmacokinetics, toxicokinetics,<br />

bioavailability, ADME, chemical characterization, impurities analys<strong>is</strong> and synthes<strong>is</strong>, bioanalys<strong>is</strong>, and microbiology.<br />

<strong>Toxikon</strong>’s extensive certifications and licenses allow it to meet international regulatory requirements for data acceptability<br />

and harmonization.<br />

To meet all applicable international GxP requirements, <strong>Toxikon</strong>’s facilities are fully reg<strong>is</strong>tered with FDA and USDA, and<br />

accredited with the Association for the Assessment and Accreditation of Laboratory and Animal Care International<br />

(AAALAC), and the International Organization for Standardization (ISO). <strong>Toxikon</strong> also has assurance with the National<br />

Institutes of Health so federally funded work can be performed at our facilities in compliance with NIH’s Public Health<br />

Service Policy on Human Care and Use of Laboratory Animals (PHS Policy).<br />

Services for Medical<br />

Device Developers<br />

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In Vivo<br />

- Sensitization/<br />

Reactivity<br />

- Acute, Subchronic and<br />

Chronic Toxicology<br />

- Implantation<br />

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In Vitro<br />

- Cytotoxicity<br />

- Genetic Toxicology<br />

- Hemocompatibility<br />

- Microbiology<br />

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Analytical<br />

- Material<br />

Characterization<br />

- Extractables and<br />

Leachables<br />

- Compendial Testing<br />

Services for Drug<br />

Developers<br />

»»<br />

In Vivo<br />

- Whole Animal Assays-<br />

PK/TK/ADME/DMPK<br />

- Toxicology/IND<br />

Enabling Studies<br />

- Small/Large<br />

Animal Models<br />

- Imaging<br />

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In Vitro<br />

- Binding Assays<br />

- Cell Culture Based<br />

Assays<br />

- Molecular<br />

Biology/Virology<br />

- Genetic Toxicology<br />

- Microbiology<br />

- Immunogenicity<br />

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Analytical/Bioanalytical<br />

- Method Development<br />

- Method Validation<br />

- Comprehensive GLP/<br />

GMP Assays<br />

Services for Biotech<br />

Product Developers<br />

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In Vivo<br />

- In Vivo Pharmacology<br />

- Toxicology/<br />

Immunotoxicology<br />

- PK/TK<br />

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In Vitro<br />

- Potency Assays<br />

- RIA/ELISA/PCR<br />

- Viral Clearance<br />

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Analytical/Bioanalytical<br />

- Method Development<br />

and Validation<br />

- Protein<br />

Characterization<br />

- Stability/Aging and<br />

Release Testing<br />

- Bioanalytical Sample<br />

Analys<strong>is</strong><br />

Custom Services<br />

»»<br />

Ocular Drug Program<br />

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Proof of Concept<br />

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Surgical Programs<br />

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R&D<br />

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D<strong>is</strong>covery<br />

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Synthes<strong>is</strong> and<br />

Formulation<br />

»»<br />

Reproductive Toxicology<br />

»»<br />

Immunoh<strong>is</strong>tochem<strong>is</strong>try<br />

and Pathology<br />

»»<br />

Imaging Capabilities<br />

Please v<strong>is</strong>it www.toxikon.com to learn more about our <strong>preclinical</strong> development capabilities.<br />

15 Wiggins Avenue Bedford, MA 01730 800.458.4141 info@toxikon.com www.toxikon.com

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