STAGE 2: SCALE
Good
Manufacturing
Practice
General
Manufacturing
Practice
Where precision delivers consistency: we manufacture to ensure quality, consistency and scalability.
Where precision delivers consistency: we manufacture to ensure quality, consistency and scalability.
Turning radical innovations
into scalable products
Turning radical innovations into scalable products
We take potentially life-changing new formulas that have made it past R&D stage and transform them into drugs that are safe, compliant, reliable and usable. This stage is all about precision and care. Because when it comes to drug development, safety is everything.
We take potentially life-changing new formulas that have made it past R&D stage and transform them into drugs are that safe, compliant, reliable and usable. This stage is all about precision and care. Because when it comes to drug development, safety is everything.
Our GMP services
TGA GMP License No.
MI-2021-LI-13035-1
APVMA License No.
2277
01
Cutting-edge
technology
The manufacturing facilities are equipped with advanced equipment and technology to deliver high-quality pharmaceutical products.
02
Quality assurance
A rigorous 21 CFR Part 11 compliant electronic quality management system ensures the accuracy, safety, and efficacy of each batch through comprehensive quality control measures.
03
Packaging
& labeling
Provide validated protocols, tamper-evident packaging and clinical trial labeling that complies with strict regulatory guidelines.
04
All-round support
We offer end-to-end support from manufacturing to packaging and logistics, streamlining the clinical trial process.
05
Regulatory
expertise
In-depth knowledge of regulatory standards across different markets ensures smooth compliance and approvals for clinical trial materials, as well as offering support for CMC and IND enabling activities.
01 / 03
ABINITIO developed a scalable, GMP compatible oral dosage form of SAi001 — the world’s first multi organ radiation protectant — translating groundbreaking research into a clinic ready product. Their advanced formulation strategies and manufacturing expertise give us confidence as we move toward first in human studies.”
Professor Christopher Sweeney
Director, SAiGENCI, South Australian Immunogenomics Cancer Institute
02 / 03
ABINITIO has been a trusted partner in the late phase manufacture of our finished topical gel product for both Phase 2 and Phase 3 clinical trials. Their GMP fill and finish capability, along with clinical packaging, labelling, and release to both local and international trial sites, has been delivered with quality and reliability.”
Arthur Kollaras
Principal Engineer & Head of Manufacturing, Recce Pharmaceuticals (ASX RCE)
03 / 03
For an ASX-listed company, confidence in execution is essential. ABINITIO’s handling of our pMDI tech transfer, GMP manufacturing, and ICH stability program was exceptional, supporting both our Phase 1 and Phase 2 clinical trials with consistent on time delivery.”
Rob Jenny
Chief Scientific Officer, InhaleRx Ltd (ASX IRX)
Our unique areas
of expertise
Our unique areas
of expertise
Full manufacture of non-sterile
dosage forms for clinical trials
Capable of handling NCEs and
high potency drug substances
(i.e. 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
randomisation services
Release for supply
Expertise with oxygen & water
sensitive molecules
Handling scheduled drugs:
S8 and S9
Complex dosage forms such as gels, creams, nanoparticles, oral medicines and powders
Biologics:
protein, peptides, RNA
and oligonucleotides
Manufacturing and testing of
orally and nasally inhaled products
THE AUSTRALIAN ADVANTAGE
THE AUSTRALIAN ADVANTAGE
Why work with an Australian firm?
Why work with an Australian firm?
01
Tax rebate
Experience success for less. You can receive up to 43.5% of your R&D spend back as part of the Research & Development Tax Incentive offering if your company’s aggregated turnover is below $20 million. If it’s above that level, your rebate is 38.5%.
02
Global market access
When you go with Australia, you can go global. Australia’s strategic partnerships and strong adherence to international standards mean that Australian clinical trial data and regulatory approvals are recognised all over the world, facilitating smoother transitions to international markets.
03
Robust research ecosystem
Australia is home to world-class universities, hospitals, clinical trial facilities, and research institutes. Together, these institutions boost innovation, enhance the scientific credibility of clinical trials, and bring about faster progress towards clinical trial.
04
Efficient regulatory environment
Australia’s Therapeutic Goods Administration (TGA) offers clear guidelines and streamlined processes for clinical trial approvals. This efficiency accelerates the pace from conception to trial, idea to impact, reducing time and cost.