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