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Extraction & Isolation

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Phytex are experts in the extraction and isolation of naturally sourced compounds for application throughout the entire drug development journey.

Contract manufacturing

Phytex is available for contract manufacturing for the pharmaceutical, nutraceutical, veterinary, food and research industries. As experts in extraction and isolation, customers can work with Phytex to outsource stages of drug development through to drug discovery and manufacture of extracts, intermediates and APIs.
 
With more than 30 years of compliance with the Australian Therapeutic Goods Administration and U.S. Food and Drug Administration, the Phytex team will produce the highest quality products to these regulatory standards, while also navigating customers through the process.
 
Customers can be confident in the service and expertise of the team. Phytex has decades of regulatory compliance experience, back-end integration with raw material farmers, growers, agronomists, breeding specialists, solvent and excipient suppliers. Our business model accommodates great flexibility of production, Australian sourced materials, Australian manufacturing and on-time delivery.

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Facilities

The Phytex manufacturing facilities are in Sydney, Australia. The team maintains the highest quality standards for all commercial products, manufactured in current Good Manufacturing Practice (cGMP) licensed and regulatory audited facilities.

 

Equipment includes:

  • 500m2 (5200 ft2) factory facility – housing various GMP dedicated areas

    • 2 x Class 8 (Class D) HEPA Filtered Cleanroom environments (ISO14644)

  • 2 x 100m2 Analytical laboratories

  • Leaf and raw material processing plant for initial crude extracts (500kg per day capacity)

  • 1L - 200L Distillation apparatus and fractional distillation

  • High-rate solvent removal and recovery equipment (Centritherm evaporators and rotary evaporators)

  • 1L – 3000L Solid-liquid extraction column capacity (ion exchange, absorption resins)

  • 1L – 2000L Liquid-liquid extraction capacity (aqueous/non-aqueous/alcohol extraction)

  • 1L – 200L Jacketed reactors

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Onsite expertise

The Phytex team comprises experts in Alkaloid extraction from natural sources with specialisation in Tropane, Indolizidine and Pyrrolizidine Alkaloids. Their focus is extraction (liquid/solid), isolation and purification of high quality, pharmacopeial compliant APIs as well as extracts and intermediates if required. The team is available to support partners through the entire drug development journey, from research and development, regulatory navigation to commercial scaling.

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