Success Stories

A biotech company developing a parenteral peptide formulation faced challenges due to the drug’s high susceptibility to surface adsorption during storage, manufacturing, and clinical administration, affecting accurate and reproducible dosing and therapeutic efficacy.

Applying our advanced analytical expertise in compatibility testing, MMIC evaluated the adsorption risk to ensure clinical trial readiness.

• Developed a validated, sensitive LC-MS method to measure drug recovery at low dose concentrations in the formulation matrix.
• Delivered critical compatibility data after assessing adsorption on plastic surfaces (PP, PVC) of extension tubing, central lines, IV bags, and ports used in clinical administration.
• Provided evidence-based recommendations for infusion system components and filtration, highlighting filter material and surface area as critical factors to consider.
• Reduced risk of drug loss during administration, ensuring accurate dosing and patient safety.

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.

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 trial

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.