mRNA – ADCs & BIOLOGICS

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mRNA, ADCs, and Biologics Development And Manufacturing

IDT is at the forefront of mRNA, ADCs, and biologics 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.

Find out how IDT Australia can support your next project

IDT is a leading provider of comprehensive solutions for mRNA, ADCs, and biologics 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, ADCs, and biologics 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, ADCs, and biologics. 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.

Regulatory Compliance

IDT is a trusted leader in the development and manufacturing of mRNA, ADCs, and biologics 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, and biologics, making us a reliable partner in advancing innovative treatments.

End to End Product Development

IDT is a distinguished pharmaceutical CDMO specialising in the development and manufacturing of mRNA, ADCs, and biologics. With a focus on innovative therapies, we offer comprehensive end-to-end services for investigational medicinal products.

Our expertise encompasses optimising APIs and large-scale production of finished dosage forms, ensuring seamless support throughout the entire process. From research and development to manufacturing investigational APIs and finished dosage forms for clinical trials, our integrated approach and unified quality system guarantee efficient and reliable outcomes.

Trust us as your partner of choice for exceptional oral finished dose development and manufacturing in the field of mRNA, ADCs, and biologics.

In-House Method Development

At IDT, our in-house expertise in method development for mRNA, ADCs, and biologics drives efficiency and optimises project timelines. This integrated approach ensures the suitability of methods before validation, providing significant benefits to later-stage clinical projects.

Furthermore, our in-house integrated analytical services streamline manufacturing operations and deliver a seamless experience to our clients. This comprehensive approach eliminates the need for external tech transfers, enabling us to maintain control over the entire development process. As a result, we deliver exceptional quality and simplify complexities in oral finished dose development and manufacturing of mRNA, ADCs, and biologics.

Quality by Design

Our commitment to the development and manufacturing of mRNA, ADCs, and biologics drives our position as a trusted pharmaceutical CDMO. Grounded in Quality by Design (QbD) principles, our development program and Tech Transfer process ensure the fulfillment of a precise Quality Target Product Profile (QTPP).

Since IDT prioritises efficient experimental design and employs risk management strategies, we optimise the development and manufacturing of mRNA, ADCs, and biologics to surpass product specifications. Our streamlined program expedites the product development and registration process, generating submission-ready data and documents.

With a strong emphasis on speed to market, our QbD program guarantees exceptional client experiences, consistently providing mRNA, ADCs, and biologics that meet the highest quality standards.

Strong Global Network Specialising in API Development

As a trusted CDMO, IDT is dedicated to expediting drug formulation, optimising processes, and minimising trial delays in oral finished dose development and manufacturing.

We foster robust collaborations with product development specialists globally, providing access to advanced research, expertise, and cutting-edge tools. Through these partnerships, we efficiently optimise process chemistry and drug product formulations, reducing delays and accelerating product development by leveraging international expertise and minimising trial-and-error experimentation.

Our collaborative approach guarantees exceptional outcomes for our clients, positioning us at the forefront of the development and manufacturing of mRNA, ADCs, and biologics.

Full-Spectrum API Manufacturer (CDMO)

As a full-spectrum pharmaceutical manufacturer, IDT excels in the comprehensive development and manufacturing of mRNA, ADCs, and biologics. 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, ADCs, and biologics, 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, ADCs, and biologics. As IDT continues to drive advancements in healthcare, we contribute to improving patient outcomes and addressing critical medical needs.

Contact IDT Australia

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