Ab Initio Supports Woolcock Institute Clinical Trial with Inhaled Therapy Manufacture and CRO Services
Ab Initio Pharma is proud to announce the successful GMP manufacture, labelling, QC release, and clinical trial support for a novel inhaled therapeutic being investigated at the Woolcock Institute of Medical Research.
The investigational product, developed for sleep and neurological health, represents a breakthrough approach to drug delivery via the pulmonary route. Manufactured under strict GMP conditions, Ab Initio delivered the full technical program including:
Analytical method development and QC
Product labelling and clinical packaging
GMP manufacture of inhalation dosage form
Batch release by a licensed facility
In a significant expansion of our capabilities, Ab Initio is also acting as the Contract Research Organisation (CRO)for the trial, supporting clinical coordination, IMP logistics, and data oversight.
“This partnership reflects our ability to deliver end-to-end pharmaceutical services, from early development through to trial execution,” said Paul Young, CEO of Ab Initio Pharma.
As a leading CDMO and CRO in Australia, Ab Initio offers integrated services that streamline product development and accelerate clinical readiness. Our model is ideal for sponsors seeking fast, compliant, and scientifically rigorous solutions.
Our capabilities include:
Formulation and development
Technology transfer and scale-up
GMP manufacturing and regulatory release
Clinical trial support, logistics, and CRO services
Ab Initio continues to expand its portfolio of inhaled and complex dosage forms, supporting Australian innovation from discovery through to patients.
For more information about how we can support your clinical program, contact us here.
