Your ADC journey starts here

Our DNA-to-IND program for ADCs is a comprehensive program integrating speed, quality and efficiency to facilitate your CMC path to IND in just 13 months.

This unique offering provides an end-to-end supply solution with reduced complexity by combining Lonza's unparalleled biologics and small molecules expertise, refined over decades, with our advanced fill and finish expertise for highly potent drug products.

Unlock the full potential of your ADC journey by harnessing the benefits of Lonza's integrated network, helping mitigate development risks for your cytotoxic bioconjugates.

Tox DS batch Tox BASM batch Program start/ Transfection Tox DP batch Tox PL batch IND ready cGMP DP batch cGMP DS batch cGMP BASM cGMP PL batch 13 12 11 10 9 8 7 6 5 4 3 2 1 from DNA to ADC IND cGMP Batch DP DS BASM Development PL DNA to Tox DS Tox DP batch IND Readiness Tox BASM (200L bioreactor) Tox PL Batch, reference standard characterization Tox DS & reference standard cGMP BASM batch cGMP PL batch incl. b atch release cGMP DS batch cGMP DP batch Regulatory document preparation 1 10 4 2 8 6 1 5 3 7 9 2 BASM Biologically Active Starting Material PL Payload - Linker DS Drug Substance (conjugated) DP Drug Product 3 4 6 7 8 10 9 10 Month 5 Tox DP batch 1

* Estimated timelines. For antibodies, from DNA transfection to delivery of IND-enabling CMC modules. Subject to terms and conditions.

Shaped around you

Our standard DNA-to-IND program for ADCs timeline is streamlined through a platform approach across drug substance and drug product activities. This involves combining our pre-established analytical platform with bespoke methods designed for your specific product. The overall program timeline is defined by specific entry criteria, primarily focusing on mAb properties, chemical conjugation steps, and concentration ranges.

Additionally, Lonza can offer a higher level of flexibility on your journey to IND, by shaping our process around your molecule's profile and technical requirements. Our program scope and timeline can be tailored to your specific needs.

Frequently Asked Questions

DNA-to-IND program is designed to streamline ADC development by combining mammalian expression, bioconjugation, and drug product development and manufacturing within a single program. Through a platform-based approach, ADC sponsors can reach their IND-enabling CMC package in as little as 13 months while reducing complexity across development activities.

An integrated ADC CDMO helps reduce development complexity by bringing together expertise across antibody development, bioconjugation, analytical services, and drug product manufacturing. Through DNA-to-IND, Lonza provides a coordinated end-to-end supply solution that helps mitigate development risks and supports a more efficient path toward IND submission.

Yes. DNA-to-IND program integrates activities spanning mammalian expression, bioconjugation, drug substance development, and drug product development and manufacturing. This enables customers to access a streamlined development pathway through a single coordinated program.

DNA-to-IND program combines mammalian expression, bioconjugation, analytical platform capabilities, and drug product development and manufacturing into one integrated offering. The program is designed to support customers throughout the CMC journey from DNA through IND-enabling activities.

Yes. While the program uses a standardized platform approach to help accelerate development timelines, Lonza can tailor the technical scope and timelines based on the molecule profile, conjugation requirements, concentration ranges, and overall development objectives of the customer.

Lonza helps mitigate ADC development risks through an integrated network that combines decades of expertise in mammalian expression, bioconjugation, highly potent payload linker and drug product development and manufacturing. Bringing these capabilities together within a single program can simplify coordination and reduce project complexity.

Lonza's DNA-to-IND program combines speed, quality, and efficiency within a single development framework. By integrating antibody expression, payload linker, bioconjugation, analytical support, and drug product manufacturing, Lonza offers customers an end-to-end solution designed to accelerate the path from DNA to IND.