Biotechnology Safety and Efficacy Testing

Safety and efficacy testing for biotechnology products

Advanced Biotechnologies Demand Effective Testing

Biotechnologies are medical therapies derived from biological agents and process. Modified living organisms or their derivatives are used in thousands of life science products that prevent, treat, or cure disease. In contrast to chemically-synthesized small-molecule pharmaceuticals, which have a well-defined structure and can be completely characterized, biotechnology products are complex in structure, and thus are usually not fully characterized in the same manner as pharmaceuticals.

Biological products can be used as stand-along therapies, or combined with pharmaceuticals or devices to amplify their effectiveness. Recent work in pharmacogenomics suggests the advance of ‘personalized medicine’ where therapies are optimized for an individual’s unique genetic makeup.

As biotechnologies become increasingly prevalent, consumers will expect and deserve products that perform as intended, with minimal risk of adverse effects.

Bringing novel therapies to market successfully is a complex, time-consuming, and expensive process. The regulatory approval pathway requires significant preclinical testing before a biotechnology is approved for clinical trials. A systematic approach is required to navigate these challenging pathways successfully. With a solid testing protocol and qualified results, developers can bring biotechnology products to market successfully, recognizing the investment of talent and resources, and supporting the health of patients worldwide.

It is important to partner with the right laboratory who will guide you from preclinical testing, through clinical trials, and ultimately to market. Preclinical testing helps ensure that your product will pass regulatory approval easily, maximizing your investment and paving the way to successful commercialization.

 

A Practical Approach to Preclinical Development

From helping you understand regulatory requirements, through risk assessment and study design, to executing testing protocols with unparalleled quality and on-time results, Toxikon is ready to help you shepherd your biotechnology products through the approval process to get them to market quickly. With over 40 years of preclinical testing success, Toxikon can be your trusted partner to help you reach your project goals for timely market launch.

 

Unparalleled Quality and Accuracy

Toxikon is a preclinical contract research organization (CRO) accredited to ISO/IEC 17025 – an extensive set of standards confirming our competency as a testing laboratory. Our operations are governed by a rigorous quality management system, ensuring that you can trust the data we deliver in support of your products.

Additionally, we are registered with the United States Food and Drug Administration and the Japan Ministry of Health, Labor, and Welfare for drug and medical testing – and we have demonstrated success with working through these agencies to complete submissions and, when necessary, defend challenges.

 

Thought Leadership in Preclinical Testing Methods

Toxikon is committed to staying at the forefront of preclinical testing by continually evaluating our study methods and research techniques.Our distinguished scientific staff not only fully understand testing requirements; they help create them. Key Toxikon staff are contributors to the professional panels and organizations that define industry best practices and influence regulation and legislation.

The study directors, scientists, and technicians working on your testing programs have access to the most current and effective methods available, executed under the supervision of industry-leading professionals. Our study directors understand the approval challenges that biotechnology developers face, and are well-positioned to help guide you through the dynamic regulatory landscape.

 

State-of-the-Art Device Testing Facilities

Toxikon has the staff, methodology, instruments, and facilities to ensure best-in-class preclinical safety and efficacy testing. With over 125,000 square feet of advanced research space, Toxikon testing facilities include:

  • comprehensive laboratories with top-tier analytical instruments
  • accredited vivarium facilities for large and small species
  • modern surgical suites with state-of-the-art monitoring, imaging and measurement systems

Toxikon’s facilities are registered with the United States Food and Drug Administration and United States Department of Agriculture, and are accredited by American Association for Accreditation of Laboratory Animal Care. We also comply with the NIH’s Public Health Service Policy on Human Care and Use of Laboratory Animals, holding an assurance allowing for the execution of federally-funded studies.

 

Biotechnology Safety and Efficacy Testing
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From helping you understand regulatory requirements, through risk assessment and study design, to executing testing protocols with unparalleled quality and on-time results, Toxikon is ready to help you shepherd your biotechnology products through the approval process to get them to market quickly.