mRNA and ADCs Development And Manufacturing
IDT is at the forefront of mRNA and ADCs development and manufacturing. Leveraging our high containment capabilities and stringent cGMP compliance, we offer fully compliant cGMP manufacturing for these emerging technologies.
Our strong collaboration with MMIC enhances our expertise in mRNA and ADCs, enabling us to deliver innovative solutions for your project requirements. With a steadfast commitment to quality and compliance, we provide comprehensive support throughout the development and manufacturing process.
Contact us today to discuss your mRNA and ADC project needs and experience how IDT, in collaboration with MMIC, can be your trusted partner in advancing these cutting-edge therapies.
IDT is a leading provider of comprehensive solutions for mRNA and ADCs development and manufacturing. With a focus on vertical integration and end-to-end services, we offer a wide range of capabilities to support the pharmaceutical industry. Here are the key aspects of our expertise:
- In-House Method Development: Our dedicated team of experts utilises in-house method development capabilities to ensure efficient and effective processes for mRNA and ADCs development.
- Analytical Excellence: Our fully equipped cGMP analytical laboratory plays a crucial role in our operations. We provide method development, analytical tech transfer and validation services for finished product methods. We also provide microbiological assessments of raw materials and finished products, including sterile formulations.
- Full Compliance: IDT operates within a fully compliant cGMP environment, adhering to the highest industry standards and regulations. This commitment to quality ensures the safety and efficacy of our products throughout the development and manufacturing process.
At IDT, we are dedicated to delivering high-quality solutions for mRNA and ADCs. With our comprehensive services, advanced analytical capabilities, and strict regulatory compliance, we provide reliable support for the pharmaceutical development and production of investigational medicinal products. Trust IDT as your partner in advancing the future of these groundbreaking therapies.
IDT is a trusted leader in the development and manufacturing of mRNA, ADCs in a strictly regulated cGMP environment. Our state-of-the-art facility has successfully passed comprehensive audits and obtained accreditation from renowned regulatory authorities, including the Australian Therapeutic Goods Administration, the U.S. Food and Drug Administration, and the Japanese Ministry for Health Labour and Welfare.
We are committed to upholding the highest standards of GMP across global markets through certifications and agreements, ensuring compliance with rigorous quality control measures for the development and manufacture of these advanced therapies. Our dedication to regulatory compliance guarantees the safety and efficacy of our mRNA, ADCs making us a reliable partner in advancing innovative treatments.
Full-Spectrum API Manufacturer (CDMO)
As a full-spectrum pharmaceutical manufacturer, IDT excels in the comprehensive development and manufacturing of mRNA and ADCs. Our expertise spans the entire lifecycle of these advanced therapeutic products, ensuring exceptional quality and regulatory compliance.
With specialised capabilities in manufacturing, chemistry, and microbiological testing, we deliver reliable and innovative solutions. Our integrated approach and unified quality system enable seamless coordination throughout the development process, minimising complexities and optimising efficiency.
Our key strengths include:
- Expertise: We have extensive knowledge and experience in the development and manufacturing of mRNA and ADCs, ensuring high-quality outcomes.
- Comprehensive Support: From initial research to market launch, we provide end-to-end support throughout the entire product development journey.
- Innovation: Our strong capabilities in innovative product development enable us to stay at the forefront of advancements in healthcare.
With these capabilities, IDT enables accelerated development and manufacturing of innovative mRNA and ADCs. As IDT continues to drive advancements in healthcare, we contribute to improving patient outcomes and addressing critical medical needs.
IDT Australia has the experience, expertise, and the technology to manage and develop production of advanced therapies.
IDT Australia was the first manufacturer in the Southern Hemisphere to make a COVID mRNA vaccine - achieved in three months from technical transfer of the project through to finished product.
Our strong collaboration with multiple researchers and university partners puts us at the forefront of development and manufacturing mRNA and ADCs, enabling us to deliver innovative solutions for your project requirements.
IDT Australia is the only Australian pharmaceutical manufacturer with the expertise and capacity to drive development of advanced therapies from clinical trials through to scaled up contract manufacturing including fill finish.
With a steadfast commitment to quality and compliance, we provide comprehensive support throughout the development and manufacturing process.
IDT Benefits:
- Experience: IDT has teams qualified and experienced in high potent small molecule R&D process and design. We have the ability to leverage the synthesis and upscaled volume from previously produced molecules (see our Product Catalog), or to develop novel compounds.
- Cutting Edge Technology: IDT offers Pilot Scale Purification Extraction, Recrystallization, Tangential Flow Filtration and Column Chromatography. A variety of isolation techniques and larger scales are available.
- Ability to Scale and Validate: IDT has the Commercial Scale Facilities to enable our partners to scale and validate.
Contact IDT Australia
If you’re looking for quality, turnkey cGMP contract manufacturing services, please get in touch with us today.