STAGE 1: SCIENCE
Research & Development
Research & Development
Where molecules become medicine: we transform scientific ideas into stable, effective formulations.
Where molecules become medicine: we transform scientific ideas into stable, effective formulations.
Find the formula for success
Find the formula for success
With many decades of combined experience, we know how to formulate products that work in the real world (not just in lab conditions). We take a new chemical entity, repurposed molecule or generic compound and formulate it into a finished dosage form.
With many decades of combined experience, we know how to formulate products that work in the real world (not just in lab conditions). We take a new chemical entity, repurposed molecule or generic compound and formulate it into a finished dosage form.
Our R&D services
How we produce medicine that's formed to perform.
01
Complete
formulation
development
- Repurposed drugs or NCEs
- Enhancing IP positions
- Complex formulations: Nanoparticles, gels, inhalation, nasal, injectable, capsules, liposome and suspensions
- Small molecules and large molecules (such as proteins and peptides), as well as newer approaches like nucleic acids
02
Analytical
development
- Technical documentation and validation
- Stability-indicating assays and impurity profiling
- Regulatory documentation and technical reports (CMC, IND/IMPD support)
- Method transfer and optimisation across platforms/labs
- Application of advanced analytical techniques to support complex formulations
- Method development and validation
03
Physico-chemical
& product testing
- Basic drug & excipient characterisation
- Extensive in vitro characterisation
- Pharmacopeia testing, including aerosol-based assessment
- Preclinical physiologically relevant cell-based models
- Thermal and advanced material characterisation (e.g. DSC, TGA, AFM, Raman)
- Stability testing
04
Particle
engineering
- Nanoparticle generation & micronisation
- Water and organic based spray drying
- Pressurised metered dose inhaler manufacturing and filling
- Liposomal formulation & lyophilisation
- Low-shear and high-shear powder and liquid mixing
05
Novel preclinical
tools
- Specialist molecular, microbiology and in vitro testing facility
- Use advanced cell culture models to evaluate NCEs and finished products
- Allows clients to predict numerous product properties such as toxicity, transport, metabolism and efficacy
01 / 02
ABINITIO created a dosing strategy for our inhaled NCE that opened a clinical path previously considered not viable. Their development of the final inhaled dosage form ensured seamless progression into first in human studies.”
Tom Wu
Principal, Apros Pharma
02 / 02
ABINITIO delivered the specialised formulation work essential for progressing RB042 toward clinical trials. Their ability to optimise aerosol performance, dose delivery, and stability across a wide dose range was central to translating our oligonucleotide therapy to the clinic.”
Siro Perez
CEO, Rage Biotech
Our facilities
We handle the whole process in-house.
When everything happens under one roof with one partner, you get more oversight and more efficiency.
Aerosol products
- Malvern Spraytec laser diffraction
- USP apparatus 1 & 3: Anderson cascade impactors for DPI & MDI
- USP apparatus 4: multistage liquid impingers (MSLI) for DPI
- USP apparatus 5 & 6: next generation impactors (NGI) DPI, MDI & nebulisers
- Fast screening impactor
- Dose uniformity analysis (DUSA)
- Nasal spray testing facility
- Breath simulation
- Integrated model lung & nasal system for deposition of aerosols on lung epithelia for pre-clinical drug transport & toxicity
- Infection models (virus/bacteria/biofilm)
- Aerosol filter deposition apparatus for evaluation of drug dissolution
- High-speed imaging
Physico-chemical
- Scanning electron microscopy (SEM)
- Microscopy with Raman chemical analysis
- Atomic force microscopy (AFM)
- Thermo-gravimetric & differential scanning calorimetry (TGA/DSC)
- Modulated DSC
- Dynamic vapour sorption (DVS)
- Particle size analysis (Malvern 3000) for wet & dry samples
- Karl Fischer water analysis
- Rheometer
- Drug dissolution (including apparatus IV for poorly soluble compounds)
- Drug, excipient & related substances analysis (HPLC, HPLC/MS, RI, UV)
Complete formulation development
- Büchi closed loop spray dryer
- Jet mill microniser
- Freeze dryer
- Rotary evaporator
- Extruder
- Liposome manufacture
- Pamasol MDI filler
- Blenders/mixers
- Fill & package
- Multiple stability cabinets
- Package testing
- Nanoparticle generator
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 and idea to impact, reducing time and cost.
