Toxikon

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Toxikon Corporation is a preclinical Contract Research Organization (CRO), with ISO/IEC 17025 accreditation that is registered with the US FDA and Japanese MHLW for drug and medical device testing. The Company provides in vivo, analytical, and in vitro testing services for the medical device, pharmaceutical and biotechnology sectors.

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http://www.toxikon.com/
Toxicon Corporation
Type Private
Founded 1977
Slogan Advancing Your Innovation
Headquarters Bedford, MA

History

Toxikon Corp. was founded as Cambridge Diagnostics in 1977 and reincorporated to its current namesake in 1982 by Dr. Laxman Desai, president and CEO.

Prior to establishing the company, Dr. Desai managed oncology drug research programs at the Dana-Farber Cancer Institute in Boston. It is through his expertise that Toxikon became established in life sciences and has continued to advance innovations in the pharmaceutical, biotechnology, and medical device industries for more than 30 years.

In 1987, Toxikon acquired the former American Biogenics, Inc., of Woburn, MA. This facility was part of the National Toxicology Program, and Toxikon expanded its toxicology and analytical capabilities from 1987 through 1995.

In 1995, Toxikon relocated to its current location in Bedford, MA, an 80,000-square-foot facility that allowed the contract research organization to further expand its testing services for medical device, biotech, and pharmaceutical markets dedicated to research and development, GLP, and GMP projects.

In 2005, Toxikon purchased the former SunOpta Ingredients Group facility directly next door to its Bedford headquarters, transforming it into more than 45,000 square feet of additional laboratory space and creating a campus-style setting and space for large animal models and additional instrumentation for bioanalytical support services. Bedford and Belgium

While Toxikon’s Bedford, MA, campus occupies 125,000 square feet of research and development space for small and large molecules and medical devices, Toxikon Europe in Leuven, Belgium, primarily focuses on analytical services, rapid microbiology, and in-vitro assays, including expanded microbiological capabilities. Toxikon also offers programs specifically designed for ocular, surgical, research and development and discovery, synthesis and formulation, and pathology.

Toxikon’s facilities are fully licensed and accredited. Additionally, the Bedford facilities have full USDA, OLAW, and AAALAC animal testing credentials. Both facilities are ISO/IEC accredited, and conduct international GxP work. Toxikon presently has approximately 75 animal rooms, with separate preparation areas, and fully equipped surgical suites supported by DVM surgeons and support services. Toxikon has approximately 200 full-time employees who serve more than 1,000 customers across the pharmaceutical, biotechnology and medical device sectors. Key members of Toxikon’s quality and regulatory staff include professionals with RAC and RQAP-GLP certifications.[1]

[2]As an industry leader, Toxikon holds the following accreditations as independent, third-party confirmation of our commitment to quality and excellence. We have all the applicable certifications, registrations and accreditations in place to address global laboratory certification and testing requirements.

  • ISO / IEC 17025 accreditation
  • United States Department of Agriculture (USDA) registration
  • United States Food and Drug Administration (FDA) registration #1220528
  • American Association for Accreditation of Laboratory Animal Care (AAALAC) accreditation
  • United States Department of Health and Human Services, National Institutes of Health, Office of Laboratory Animal Welfare (OLAW) assurance #D16-00139 (A3223-01).

Toxikon: What’s in a Name? The word “toxikon” is as old as Greek Mythology and as novel as the new product development it fosters. The Online Etymology Dictionary, as well as numerous other sources on the origin of words, says “toxikon” is the ancient Greek word meaning “poison arrow.” In fact, there was a time during the Society of Toxicology's 50-year history that its logo sported a toxikon. The meaning behind Toxikon’s moniker is as deliberate as our mission: to provide sound science related to the safety, dosing, and efficacy of medical products with the precision and speed of a heroic archer —from pre-market safety through post-market surveillance.[3]

What's Next?

Building on over 40 years of testing expertise, Toxikon will increase our ongoing investment in high-quality testing and consulting services. Our focus remains on developing our core services of biocompatibility testing, extractable and leachable analysis, and analytical chemistry services, while aggressively staying on the forefront of research and regulation. We will continue to deliver innovative facilities, methods, and capabilities, and provide our sponsors the most comprehensive suite of life science product development, testing and follow-on support services available in the market. [4]

Services Offered

  • Biocompatibility
  • surgical and ocular models
  • extractable & leachable (E&L)
  • risk assessments, microbiology (cleaning, disinfection and sterilization validations)
  • toxicology (including toxicity, genetic toxicology and carcinogenicity)
  • PK, TK, ADME, chemical characterization
  • impurities analysis
  • synthesis and bioanalytical.

Top 5 Recent Tweets

DateAuthorComment
October 19, 2020ToxikonCROOcular products present unique challenges when it comes to developing a #preclinical safety & #efficacy program. Le… https://t.co/aJgsyakcIX
October 16, 2020ToxikonCROImproper sample preparation can cause a large number of unnecessary testing delays for your #medicaldevice… https://t.co/HsTOVXGMxv
October 15, 2020ToxikonCRODeveloping dental products? Let us ensure the safety of your patients smile with a #preclinical safety & efficacy p… https://t.co/5FT8isF5kT


Top 5 Recent News Headlines

PepTalk

1/9-1/12 Hilton San Diego Bayfron San Diego,CA

The Protein Science Week is one of the largest annual gatherings of protein science researchers in the world. In its 16th year, PepTalk attracts nearly 1,300 experts from academia, biotech and pharma who come together for one week of intensive learning and networking to discover new opportunities and promising partnerships.

Visit us at Booth #500

MD&M West

2/7-2/9 Anaheim Convention Center Anaheim, CA

MD&M West is the annual event. It is where the "best-of-the-best" in medical device suppliers showcase their capabilities, capacities and innovation.

Visit us at Booth #2831

PharmaED - Extractables, Leachables and Elemental Impurities

03/06-03/07  Racquet Club of Philadelphia, PA

Strategic Development, Safety & Regulatory Compliance, and Commercialization of Pre-Filled Syringes.

SOT ToxExpo

03/12-03/16 Baltimore Convention Center, Baltimore, MD

ToxExpo unites 350+ toxicology-related companies and organizations with 6,800+ attendees over three days. Exhibitors debut the latest products and services to executives and industry leaders.

Visit us at Booth #1813

Interphex

03/21-03/23 Javits Center New York City

INTERPHEX (International Pharmaceutical Expo), sponsored by PDA (Parenteral Drug Association), is the single source for pharmaceutical, biotechnology, and medical device full product develop life cycle solutions to safely and cost effectively develop and manufacture all dosage forms with a unique combination of exhibition, no cost technical education, workshops, partnering opportunities, and networking events.

Visit us at Booth #1959

33rd SQA Annual Meeting & Quality College

Clinical (GCP), preclinical (GLP) and manufacturing (GMP) research in industry, government, academia and consulting. The 33nd SQA Annual Meeting and Quality College will be held 26-31 March 2017 in National Harbor, Maryland, USA near Washington, DC. The theme of the conference is District of Compliance

Visit us at Booth #314

BIOMEDevice

5/3-5/4 Boston Convention Exhibition Center, Boston, MA

Industry thought leaders and more than 300 leading exhibitors for you to explore. Held in partnership with MassMEDIC, New England’s leading medical manufacturing association, BIOMEDevice gives you direct access to the latest medical technologies, advanced manufacturing techniques, new materials, and suppliers from every step in the medical manufacturing process.

Visit us at Booth #834

ARVO

5/7-5/11 Baltimore Convention Center, Baltimore, MD

The Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) is the largest gathering of eye and vision researchers in the world, attracting over 11,000 attendees from more than 75 countries. About 45% of our attendees are from outside the U.S.

Visit us at Booth #1927

Extractables & Leachables USA

5/9 -5/11 Tyson's Corner in Falls Church, VA

The Smithers Rapha Extractables & Leachables conferences, held in both the US and Europe.

Masschusettes Life Sciences Innovation (MALSI) Day

6/1/2017 Harvard Club of Boston

10th Massachusetts Life Sciences Innovation (MALSI) Day is the biggest day for life sciences startups and innovation in the Commonwealth of Massachusetts.

Medical Device Summit

6/8-6/9 Boston, MA

Future trends of Medical Device Regulation, Risk Management, UDI, and Recall Complaint Management. 

Association for the Advancement of Medical Instrumentation Annual Conference

6/9-/6/12 Austin Convention Center, Austin TX

One-stop source for information about the latest innovations, upgrades, and advances in healthcare technology from more than 200 medical equipment manufacturers, including many of the world’s leading companies and service providers.

Visit us at Booth #1232

MD&M East

6/13-6/15 Jacob K. Javits Convention Center

MD&M East Expo and Conference is the largest, most important and comprehensive medical manufacturing event on the East Coast. It’s the gathering point for more than 500 leading Medtech suppliers and manufacturers, including 3M, Abbott, Nypro Healthcare, Phillips-Medisize, and Stratasys. Your pass gives you direct access to them all!

Visit us at Booth #1744

DeviceTalks Minnesota

6/26-6/27 InterContinental St. Paul Riverfront in St. Paul, MN

World-class education and insights from industry luminaries and a technology showcase featuring the hottest Medtech companies in the marketplace.

BioProcess International Boston

9/25-9/28 Boston, MA

1800+ bioprocessing professionals made up of global innovators, suppliers, academia and associations who can help you achieve commercial success for your novel therapeutics.

Visit us at Booth #731

PharmaED Transdermal and Intradermal Drug Delivery Systems

9/28-9/29 Racquet Club of Philadelphia, PA

Pharma Ed brings together leading researchers in the field to share the most recent advances in the design, formulation, and delivery of skin-mediated therapies and vaccines.

DeviceTalks Boston

10/2/2017

DeviceTalks is a conversation among leaders. It’s an evening for an exchange of ideas, insight and contacts among the pioneers of the medical technology industry.

Visit us at Booth #401

PharmaED Cleaning Validation Summit

10/2-10/3 Racquet Club of Philadelphia, PA

Today's regulators are applying more fine-grained specifications and demanding more sophisticated procedures for planning, executing, and documenting your processes throughout a drug product's lifecycle.

Medical Tubing 2017

10/10 - 10/11 Crown Plaza Woburn, MA

Medical Tubing 2017 will offer lively interaction between the international panel of speakers and delegates in attendance. Join us for a comprehensive overview of the latest material, technology and business trends.

Medical FluidBags

10/12-10/13 Sheraton La Jolla

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of USP and ICH guidelines, as well as the upcoming revisions to three major ISO 10993 standards.

NASS Annual Meeting

10/25 - 10/28 Orlando, FL

The North American Spine Society is a global multidisciplinary medical society that utilizes education, research and advocacy to foster the highest quality, ethical, value- and evidence-based spine care for patients.

MD&M MN

11/8 - 11/9 Minneapolis, MN

Attend MD&M Minneapolis and find everything you need to design and develop the next generation of medical devices and equipment. Get immediate access to the products, supplies, materials, technologies, ideas, and suppliers required for every stage of the product development lifecycle.

Visit us at Booth #1929

BIOMEDevice San Jose

12/6-12/7 San Jose McEnery Convention Center, CA

BIOMEDevice San Jose showcases emerging trends and innovations that will set the tone for the biomed industry in 2017 and beyond. The conference offers training on digital device trends and exploring effective ways to overcome barriers to market entry, all in a two-day Connected Health Device Development Summit

Visit us at Booth #1016

Pre-Filled Syringes West Coast

12/7-12/8 La Jolla, California

Strategic Development, Safety & Regulatory Compliance, and Commercialization of Pre-Filled Syringes

DeviceTalks California

12/11-12/12 Hilton Orange County/Costa Mesa, Costa Mesa, California

DeviceTalks is a conversation among leaders. It’s an evening for an exchange of ideas, insight and contacts among the pioneers of the medical technology industry.


Top 5 Lifetime Tweets

Top 5 Lifetime News Headlines

References

http://www.toxikon.com/about/history.cfm

https://www.linkedin.com/company-beta/43514/
  1. http://www.toxikon.com/about-us/quality-assurance.cfm
  2. http://www.toxikon.com/about-us/accreditations.cfm
  3. http://www.toxikon.com/about-us/history.cfm
  4. http://www.toxikon.com/about-us/history.cfm

Verification history