SCIENCE MATTERS

As the COVID-19 pandemic continues to evolve, Teknova remains committed to keeping our employees and their communities safe while we support your diligent research and product development for tests, vaccines, treatments, and other solutions for COVID-19.

COVID-19 SOLUTIONS

Viral Transport Media for Diagnostic Testing

Teknova Active Transport Medium (ATM) is a proprietary, non-propagating transport medium for clinical specimens intended for analysis by molecular or antigen assays. This room temperature–stable medium maintains organism viability for up to 72 hours at room temperature.

Teknova ATM complies with the US Food and Drug Administration (FDA) COVID-19 Transport Media Policy, July 2020 guidelines and is distributed under this policy after following the FDA notification process.

Teknova Viral Transport Medium (CDC Formulation) is a non-propagating transport culture medium that allows molecular or antigen assays for the analysis of clinical samples that may contain viruses. This medium must be stored at 2–8°C and will maintain organism viability for up to 72 hours at 2–8°C.

Teknova Viral Transport Medium is manufactured according to the formulation and standard operating procedure of the US Centers for Disease Control and Prevention (CDC). All viral transport media supplied by Teknova are in compliance with the US Food and Drug Administration (FDA) COVID-19 Transport Media Policy, July 2020 guidelines and are distributed under this policy after following the FDA notification process.

Teknova 0.85% Saline Solution is suitable for transporting viral samples as well as preparing test solutions of organisms.

CUSTOM GMP MANUFACTURING

Vaccine Development and Production

Teknova facilities are ISO 13485:2016 certified and US FDA 21 CFR Part 820 compliant, ensuring high quality, traceability, change control, and appropriate documentation.

Upstream processing

Choose from an extensive selection of ready-to-use pre-poured agar plates and liquid culture media for the growth and maintenance of cells or create your own custom media.

Downstream processing

We offer a variety of mobile phases for filtration and chromatography. Mobile phases are available for the purification and manufacture of DNA, RNA, antibodies, proteins, and small-molecules, and can be customized to your application and scale. Choose from our selection of buffers, solutions, and reagent-grade water, all of which are available as GMP, or work with our team to create your own custom GMP formulations. We also produce standard and custom RUO and GMP buffers for the discovery, development, and purification of proteins.

Molecular Biology Buffers and Water

We offer custom and inventoried molecular biology buffers for incorporation in research and clinical grade assays. Our Tris buffers and DNA suspension buffers are commonly used in kits for resuspension of oligo-based assays and controls. All buffers manufactured by Teknova are tested for sterility, conductivity, osmolality, and pH. Additional QC testing for endotoxins, presence of nucleases, and bioburden is available on request. We ensure that our research- and clinical-grade water, as well as the water used to manufacture our products, meets the highest standards of quality set by the United States Pharmacopeia (USP Water for Injection) and American Society for Testing and Materials (ASTM Type I). We monitor our water quality continuously. Additional QC testing is performed on water for specific applications or, upon request, for custom products. Our proprietary, modular production facilities provide the flexibility to meet your unique product requirements. With our high-throughput manufacturing and dispensing capabilities, we can deliver your formulations of sample collection or testing solutions in single-use tubes. From raw material sourcing to custom packaging, we continuously monitor and manage our supply chain to ensure there is no disruption in our ability to deliver your products.

  • ISO 7 clean rooms and ISO 5 manufacturing areas for aseptic processing
  • Single-use biopharma tanks
  • Manufacturing scales up to 2000 L
  • Manual, semi-automated, and fully automated flexible filling capabilities accommodates microliters to thousands of liters
  • High-throughput filling capacity up to 1 million tubes/week

Quality control and analytical tests available include:

  • Bioburden
  • Endotoxin
  • Osmolality
  • Stability

We implement strict document control practices to ensure the safety of your intellectual property. Safeguards include:

  • 24/7 monitoring and video tracking
  • Triple-redundant backups
  • SCADA (Supervisory Control and Data Acquisition) integration with alerts
  • Cloud vaults

For more details visit our GMP manufacturing page.

DEDICATED CHANNEL FOR COVID-19 PRODUCT INQUIRIES

We have a dedicated channel to prioritize and expedite orders. For all reagent inquiries related to COVID-19, please contact covid19@teknova.com.