Success Stories

Simplification of a Complex 26-Step Synthesis Method

• A US-based company with an innovative new oncology drug for metastatic breast cancer
• Across 15 projects and ongoing engagement, the MMIC was  able to:
  • Translate a complex 26-step synthesis method to a commercially viable, high-yielding, scale-up method capable of producing kilograms of the drug
  • Develop prototype drug, reference standards and formulation batches to support preclinical development
  • Introduce and support technical transfer of drug manufacturing to a Melbourne based GMP manufacturer
• Advances in preclinical support have allowed the company to now progress to clinical trials in Melbourne and Sydney and ongoing development work with a Melbourne based CRO.

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Innovative Nasal Formulation to Combat COVID

• In 2020, The MMIC worked closely with clinicians at Royal Melbourne Hospital and Peter MacCallum Cancer Centre to support a clinical trial to investigate an interferon nasal spray to prevent respiratory infections such as COVID-19. Over 440 subjects participated in the trial
• Drawing on our expertise in respiratory formulation and delivery the MMIC was able to:
  • Successfully developed two nasal formulations of interferon from existing injectable formulation, including working closely with the Peter Mac Pharmacy to manufacture the formulation
  • Adapt the nasal formulation in light of global supply issues with interferon injections
  • Develop complex assays and undertook stability studies to ensure product viability and inform batch manufacturing intervals for the trial
  • Source and recommended suitable nasal devices and evaluated them to ensure optimal performance and dose consistency.

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Significant Solubility Enhancement Through Innovative Formulation Techniques

• A Victorian biotech company with a novel drug for neuropathic pain could not progress to clinical trials as the drug could not dissolve into solution for injection
• After unsuccessful attempts by a US-based research facility, the MMIC, via an Innovation Connection Grant, was able to:
  • Improve drug solubility by over a 1000-fold in a pharmaceutically acceptable injection in a matter of weeks that ensured the clinical viability of the drug
  • Prepared formulation batches to support preclinical development, including the NIH in the US
  • Worked closely with Adelaide Hospital Pharmacy to scale up formulation compounding to support clinical trials
• The advanced and novel formulation expertise provided by the MMIC has allowed the company to undertake Phase I trials and facilitate further capital raising to support the next stages of development.

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