Abinitio

About
ABINITIO

About
ABINITIO

In drug development, miscommunication, handovers and siloed processes often cause hurdles and hassle all along the way. We're here to make the process easier by covering all three key stages of development, simplifying the journey and anticipating every challenge.

In drug development, miscommunication, handovers and siloed processes often cause hurdles and hassle all along the way. We're here to make the process easier by covering all three key stages of development, simplifying the journey and anticipating every challenge.

Powering your path
from molecule to market

Powering your path
from molecule to market

Whether it’s R&D, GMP or Clinical Trials, we’ll support you for the whole journey.

Despite all the setbacks and hurdles it puts in people’s way, we make the drug development simpler, easier and less fraught with risk.

We support you throughout the three key stages of the development lifecycle, from Research & Development and Manufacturing to Clinical Trials, so you can manage everything with one partner.

We unlock the power of three across wide range of complex dosage forms, including topical, oral, nasal, respiratory, nebulisers and more, for both human and veterinary use.

The people who
make it possible

The people who
make it possible

The smarter the partner, the smoother the path. Our team leads have deep expertise in every stage of drug development. From both a theoretical and practical point of view, they have a deep understanding of the challenges of development, and know how to overcome them.

FROM DISCOVERY TO DELIVERY · FROM DISCOVERY TO DELIVERY · FROM DISCOVERY TO DELIVERY · FROM DISCOVERY TO DELIVERY ·

Our values

The principles that help us

put your vision into action.

01

Expertise

We bring experience, scientific rigour and hard-won insight.

02

Collaboration

We support you through every stage of the journey and consult with you on every decision.

03

Adaptability

We adapt fast, think ahead and embrace change.

04

Resilience

We overcome challenges with persistence and purpose.

From insight to impact.

From concept to cure.

From bench to bedside.

From research to reality.

From molecule to market.

01 / 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)

02 / 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)

03 / 03
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

ABINITIO: our journey
from the beginning

ABINITIO:
our journey from
the beginning

Why we got started, how we kept going, and what drives us forward.

2019

We were founded in 2019, a spin-off by the University of Sydney, in partnership with Sydney Local Health District and the peak industry body, ARCS. By end of the year, we found our GMP Manufacturing site at Camperdown.

2020

Contruction of our GMP site began, R&D facilities were leased in Glebe and our R&D services fully opened for business in July 2020 to spearhead our construction.

2021

Construction of our GMP site completed during COVID. We appointed and recruited our GMP team to help set up our GMP facility for TGA inspection.

2022

Our GMP Facility was completed, with a TGA license granted in Oct 2022. Our GMP Manufacturing services officially got underway in Dec 2022. And by the end of the year, we were listed as one of Australia's Fastest Growing Start-Ups by the Australia Financial Review.

2023

Our APVMA license was approved and we expanded our R&D facility to Macquarie Park.

2024

We went paperless and implemented an electronic QMS and e-lab books.

2025

We expanded and built out our CRO offerings, providing an end-to-end solution, from clinic through to trial.

2026

Today, ABINITIO proudly covers the whole development journey, giving clients everything they need to get from molecule to market.

2019
2020
2021
2022
2023
2024
2025
2026

Clients & partners

Clients & partners

No journey happens alone. Here are some leading institutions we‘ve partnered with.

Go with ABINITIO

Whether you need us for the whole path, or just one part, we deliver what matters most: progress.

Credentials:

Knowledge is power

Credentials:

Knowledge is power

The credentials behind our clinical success.

GMP License No.

MI-2021-LI-1305-1

Veterinary License No.

2277

GMP License No.

MI-2021-LI-1305-1

FAQs

Simple answers to common questions we receive.

What is R&D?

R&D, or Research and Development, is the process through which scientific ideas are transformed into safe, effective, and innovative treatments. At ABINITIO, it means combining rigorous research, discovering how diseases work and identifying new therapeutic possibilities, with thoughtful development, where those discoveries are tested, refined, and brought closer to helping patients. It’s the vital engine that drives medical progress, where bright ideas become better medicines.

What is GMP?

GMP, or Good Manufacturing Practice, is all about making medicines with care, consistency, and integrity. It’s the strict set of quality standards that ensures every product is made safely, cleanly, and exactly as intended, from the first ingredient to the final package. Every dose we produce meets the highest standards of safety and reliability, so patients and healthcare professionals can have complete confidence in the treatments we deliver.

What are Clinical Trials?

Clinical trials are where things get real. They're carefully designed studies that help us understand whether a new treatment is safe, effective, and truly beneficial for human patients. They’re the bridge between scientific discovery and everyday medical care, where promising research meets real patients, under the close guidance of doctors, scientists, and ethics experts.

What’s the process for working with us?

Working with ABINITIO is simple, collaborative and tailored to you. We start by listening, understanding your goals, challenges, and the outcomes you want from it all. From there, we design a clear, step-by-step plan that brings together scientific insight, regulatory expertise, and open communication. You’ll always know where things stand, what’s next, and how we’re moving forward together. Whether you need us for all stages, or just one, we'll be right by your side, until you're out the other side.

Can I only work with you for one or two phases of development?

Absolutely. Our offering is end-to-end but modular, which means you can pick and choose which stage of the process you need us for. Whether you need us for one stage, two stages or all three stages, we can help.

What kind of dosage forms can you help me with?

We can help with a wide range of complex dosage forms, including Topical, Oral, Nasal, Injectables, Opthalmic and Respiratory, to name but a few.

How quickly can you get me to trial?

We can get you from bench to clinic in 18 months. Our integrated process results in a faster process, because you don't have to use multiple suppliers and there's less handover friction at each stage.

Am I eligible for a tax incentive?

Yes. ABINITIO is a registered RTGI service provider, so all three phases of the process count as research under the Australian Government's tax incentive schemes.