Contract Manufacturing Services

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Trusted Pharmaceutical Manufacturing Services in Melbourne

We specialize in the manufacture of high containment, high potency Active Pharmaceutical Ingredients (HPAPI) and Finished Dose Form (FDF) production in a full cGMP environment.
Our FDF capabilities includes manufacture of sterile injectables as well as emerging advanced therapies like encapsulation of mRNA and conjugation of Antibody Drug Conjugates (ADCs)

We provide a comprehensive range of contract development and manufacturing (CDMO) services, working collaboratively with pharmaceutical partners to manufacture APIs and finished dose medicines for both local and global markets including clinical supply.

Small Molecule R&D and Commercial Scale API Synthesis	Finished Dosage Form
State of the art automated and modular 100L, 400L, 4000L facility, includes 2 x 4000L, 2 x 400L and 2 x 100L reactors and Rosenmund filter receiver/drier	Tablets - 22,000 to 136,000 tablets per hour
2000L facility equipped with 3x 2000L reactors, rotary driers and centrifuges	Capsules - 38,000 per hour
400L facility equipped with 400L & 63L reactors alongside multiple distillation reactors and Nutsche filters	Sterile liquid /lyophilisation, fill and finish facility – 3,000 (20mL) capacity
250L facility equipped with 2x 250L, 2 x 63L reactors and distillation capability	Support manufacture of clinical investigational products under full cGMP
100L facility equipped with 2x 100L reactors	Liquid fill (medicinal cannabis)
50L pilot-scale suites
Chromatography suites
Medicinal cannabis extraction capability
Bench-scale R&D laboratories

IDT Australia operates a cGMP manufacturing facility in Victoria. Our facility includes high containment and high potency manufacturing suites accommodating active pharmaceutical production from milligrams through to large-scale commercial projects. We also specialise in the manufacture of finished dose forms for pre-clinical and clinical trials (Phase I – Phase III), including:

Solid dose oral.
Liquid dose oral.
Sterile injectables.

Our cGMP analytical laboratory is fully equipped to provide a comprehensive range of services, as follows:

Finished Product Method development and validation.
Analytical technology transfer.
QC and Microbial testing for raw materials and finished products.
Stability assessment of products manufactured under all ICH conditions.

Regulatory Compliance

IDT Australia manufactures pharmaceuticals in a cGMP environment. Our facility has been audited and accredited by the Australian Therapeutic Goods Administration, the U.S. Food and Drug Administration, and the Japanese Ministry for Health Labour and Welfare. Our status as a high quality GMP manufacturer extends to Europe and Canada via The Mutual Recognition Agreement. The facility holds S8 and S9 licensure, which underpins our medicinal cannabis extraction and finished product portfolio, as well as the development and manufacture of psychedelic materials for clinical trials.

End to End Product Development

Throughout our history as a pharmaceutical CDMO, we have developed, manufactured and contributed to projects ranging from optimization of APIs for early-stage clinical programs through to manufacture of finished dosage forms at scale. We take pride in our ability to offer an end-to-end services for the development and production of investigational medicinal products. With our extensive experience, technical proficiency and ability to scale, we are the perfect partner for your clinical or preclinical projects. At IDT Australia, we provide end-to-end support for your project, starting from the initial research and development stages, through to the production of investigational APIs and finishing with the manufacture of finished dosage forms for use in clinical trials; all conducted one the one site, under a single quality system

In-House Method Development

IDTs in-house method development and analytical services are a crucial component of our value proposition, allowing us to provide comprehensive analytical support for every stage of the product development process. Easy access to in-house method development facilitates efficiencies during development and shortens overall project timelines. Additionally, conducting method development alongside process development activities also ensures that methods are fit for purpose prior to initiation of validation works required for later stage clinical projects.
Operating within a full cGMP environment, our team is committed to ensuring the highest standards of quality and regulatory compliance in all our work. By integrating analytical services into our operations, we streamline the manufacturing process and provide our clients with a truly seamless experience that avoids unnecessary tech transfers to external analytical or formulation providers as these components of the development process are conducted in-house.

Quality by Design

As a pharmaceutical,CDMO we're committed to delivering high-quality products that meet the needs of our clients. Our development program and Tech Transfer process is based on Quality by Design (QbD) principles that focuses project activities on developing and meeting the requirements of a Quality Target Product Profile (QTPP). This ensures all development activities are focused on efficient experimental design using a risk management based approach, resulting in APIs and finished dosage forms that have been optimised to meet and exceed the product specification as defined in the QTPP ., ensuring that quality is built into the product from the very beginning. This program is designed to generate data and documents that are submission-ready, accelerating the product development and registration process.
At IDT Australia, we understand the importance of speed to market. That’s why we strive to deliver products that meet the highest quality standards in a timely and efficient manner. With our QbD program, we're committed to delivering on this promise and providing our clients with the best possible experience.

Strong Global Network Specializing in Pharmaceutical Development

As a pharmaceutical CDMO, we understand the importance of rapid drug formulation, process optimization and the criticality of ensuring our clients trials are not delayed.We've established strong collaborations with product development specialists both in Melbourne and globally.
These partnerships provide us with access to cutting-edge research and development expertise and tools, allowing us to optimise process chemistry and drug product formulations quickly and efficiently. By leveraging the expertise of our partners and minimising trial and error experimentation during development, we're able to reduce delays and accelerate product development times. With our collaborative approach, we're committed to delivering the best possible outcomes for our clients.

HPAPI Manufacturing and Vertical Integration for Rapid Material Supply

IDT has built a solid reputation comprehensively integrating containment measures across every stage of development, providing HPAPI handling and containment services from API development through to commercial manufacturing

As a pharmaceutical API manufacturer, our focus is the manufacture of specialty APIs and integrating them into finished dose forms.
This vertical integration occurs on the same site and under the same quality system, providing a streamlined and efficient process for our clients. This " end-to end," holistic approach ensures a speedy supply of clinical materials, creating efficiencies for project timelines and reducing the effort associated with multiple tech transfers.
Our API team consists of professionals who have experience in working with a diverse range of synthetic processes and are supported by analytical and quality professionals from large pharmaceutical companies, who operate within a small biotech envelope. This allows us to combine the best of both worlds: the expertise of a large pharma company, with the agility and flexibility of a smaller organisation. With our capabilities and expertise, we're committed to delivering the highest quality products and services to our clients.

Experts in manufacturing specialty APIs.
Integrating APIs into finished doses on-site under a single quality system.
Streamlined and efficient development process based on Quality by Design principles.
Wholistic approach to development, ensuring for a speedy supply of clinical materials.
Combining large pharma expertise with small organisation flexibility.
Committed to delivering the highest quality products and services to our clients.

Medicinal Cannabis & Psychedelics (Processing, Extraction & Finished dosage forms)

IDT Australia is dedicated to staying at the forefront of the industry and providing cutting-edge solutions to our clients. That's why our cGMP manufacturing facility is fully accredited to offer medicinal cannabis processing and extraction up to a tonnage scale, including conversion to finished dosage forms. This places us in a leading position within the medicinal cannabis manufacturing space.

We also support manufacture of psychedelic APIs and finished dosage forms that are designed within the scope of recent regulatory guidance to ensure our clients requirements continue to be met as the demand for these emerging therapies increases.

Our facility is equipped with state-of-the-art technology and staffed by experienced professionals who are committed to ensuring the highest standards of quality and regulatory compliance. This allows us to provide our clients with a full range of services, from processing and extraction to the production of finished dosage forms. With our expertise and capabilities, we're able to meet the unique needs of our clients in the medicinal cannabis space and help bring their products to market as efficiently and effectively as possible.

Find out how IDT Australia can support your next project

Contact IDT Australia

If you’re looking for quality, turnkey cGMP contract manufacturing services, please get in touch with us today.