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Safety Testing Capabilities

Safety and Biosafety Testing Services

SK pharmteco has analytical specialists at both ends of the therapeutic spectrum, from chemical and pharmacological small molecule safety testing to complex biologics safety testing methods –– ensuring every pill, vial, or syringe is safe for human use.

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Our teams have the training, technology, and regulatory know-how to support safety assessments throughout the full lifecycle of a therapy.

This spans from preclinical safety testing through clinical trials and on to approval and ongoing pharmacovigilance. Working out of dedicated labs, our teams perform in vitro studies to safeguard every batch.

Learn more about our cell and gene therapy analytical services.

Specific safety and biosafety testing services include:

  • Adventitious virus testing
  • Replication virus testing (RCV), including replication-competent lentivirus (RCL), adenovirus (RCA), and adeno-associated virus (rcAAV) testing 
  • Sterility, bioburden, endotoxin, and mycoplasma testing
  • Environmental and water testing
  • Elemental impurities testing and analysis
  • Microbiological testing, including sterility testing of products such as injectables

Where needed, we offer custom safety testing to explore specific concerns associated with a given drug substance or product. This includes identifying potential contaminants from a custom process. 

Safety & Biosafety Testing Capabilities

Phase- and Project- Appropriate

Safety testing during clinical development looks very different than the methods used for approved drug products. With our decades of experience, we’re able to guide pharma and biopharma partners through the specific requirements for each filing, without pursuing unnecessary tests.

Sterile Facilities for Accurate Microbial Detection

Our laboratories are designed and operated with sterility in mind, allowing us to provide reliable microbiological testing every time. This includes total microbial count and bacterial endotoxins, chemical analysis of water and water system validation, and more.

Your Partner in Innovation

New modalities require new safety testing methodologies. SK pharmteco has a long history of innovating to meet our partners’ needs when challenging or unique situations arise. We meet the challenge with custom methods and state-of-the-art equipment to forge a safe path forward.

Custom Safety Testing with SK pharmteco

Safety and biosafety testing requirements differ based on a range of variables, including the manufacturing location, the development process, and the end market for your commercialized drug. Whether that’s the U.S., Europe, or further abroad, we have you covered. SK pharmteco’s global team understands the requirements for many international regulatory organizations, including the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Food & Drug Administration (FDA), and the European Medicines Agency (EMA). We work with our partners to develop safety and biosafety testing methods that comply with the regulatory agencies that are relevant to your therapy.

Interested in a quote for analytical testing services?

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