What is a CDMO in pharmaceuticals?
CDMO stands for Contract Development and Manufacturing Organisation, a company that provides outsourced drug development and manufacturing services to pharmaceutical and biotechnology companies.
How do I choose the right CDMO for my project?
Choosing the right CDMO involves evaluating their technical capabilities, regulatory experience, capacity, and track record with projects similar to yours. Important factors include the CDMO’s expertise with your dosage form or molecule type, the quality of their cGMP systems, and their ability to scale from development to commercial production.
What does tech transfer mean in pharmaceutical manufacturing?
Tech transfer is the process of transferring a manufacturing process, analytical methods, and product knowledge from one site or team to another. This may involve moving from R&D to a cGMP facility, from one manufacturer to another, or from clinical to commercial scale.
What does method development, validation, and verification involve?
Method development is the creation and optimisation of analytical tests to measure a product’s quality, potency, and purity. Method validation ensures these tests are accurate, precise, and reliable, while verification confirms the method works correctly in a specific laboratory or production setting.
What scale and stages of manufacturing does IDT Australia handle?
IDT Australia can manufacture from pre-clinical to commercial scale, covering quantities from milligrams to kilograms.
What does “cGMP” mean?
cGMP stands for current Good Manufacturing Practice. It is a set of regulations and standards that ensures pharmaceutical products are consistently produced and controlled to meet quality standards. IDT’s facilities comply with cGMP guidelines and are audited by regulatory authorities, including the Australian TGA and the U.S. FDA.
Does IDT Australia manufacture both drug substance and drug product?
Yes, IDT Australia can manufacture API and finished dose forms such as capsules, tablets, non-sterile liquids, and sterile injectables (vials).
Can IDT manufacture high-potency or cytotoxic APIs?
Yes. IDT Australia specialises in high containment, high-potency APIs, including cytotoxic compounds, using specialised containment systems.
Does IDT Australia support technology transfer from other sites?
Yes. IDT Australia supports technology transfer, including formulations, method development, and scale-up from R&D or other sites to their cGMP facility.
Does IDT Australia provide analytical development services?
Yes. IDT Australia has a full cGMP analytical laboratory including microbiology services for method development, validation, stability studies, and quality control testing.
How many mRNA vaccines has IDT Australia manufactured?
IDT Australia has manufactured more than 17 mRNA vaccines to date.
What reactor sizes are available at IDT Australia?
IDT Australia operates reactors ranging from 5 L to 400 L.
Does IDT hold Schedule 8 and Schedule 9 licenses?
Yes. IDT Australia holds both Schedule 8 and Schedule 9 licences.
Does IDT manufacture veterinary products?
Yes. IDT Australia manufactures veterinary products and holds APVMA licensure.
How can I engage with IDT Australia for a development or manufacturing project?
For development or manufacturing projects, please contact: [email protected]
