GMP Manufacturing Services
Ab Initio has a state-of-the-art ISO 8, Grade D manufacturing facility purpose built for the manufacture of non-sterile dosage forms. The facility is TGA licensed (MI-2021-LI-13035-1) and can produce cGMP material for clinical trials.
GMP manufacturing services include:
Full manufacture of non-sterile dosage forms for clinical trials
Inhalation products
DPI, pMDI, soft mist and nebulisers
Liquids & Suspensions,
Capsules for oral administration,
Suppositories & pessaries
Semi solids, Creams & Ointments
Nasal products
Susspensions & Solutions
Powders & Granules
Lyophilised products
Capability to handle NCE’s and high potency drug substances (ie hormones, steroids, antibiotics)
Placebo manufacturing
Utilisation of dedicated equipment and single use technologies
Experienced in technology transfer (bench to production scale)
Temperature and humidity-controlled cleanroom.
Labelling, packaging, blinding and randomization services
Quality management system compliant to PICs 09-15
Release for supply
NCE and potent molecules
Speciality: Handling NCEs and potent molecules for first in human clinical trials where human toxicology is to be determined
Inhalation product manufacture
Speciality: Inhalation product manufacture of dry powder and pressurised metered dose inhalers
Intranasal product manufacture
Speciality: Formulation and manufacture of liquid and powder based intranasal products
Complex dosage forms
Speciality: Manufacture of complex dosage forms including lyophilised products, biomolecules and nanoparticles