DNA-to-IND Programs

Q: What is a DNA-to-IND program, and how does Lonza support it?

Our DNA-to-IND program is a fully integrated offering that accelerates the path from DNA sequence to Investigational New Drug (IND) submission. It brings cell line development, process and formulation development, analytical testing, and regulatory documentation together in a single workflow. By minimizing handovers and aligning all Chemistry, Manufacturing, and Controls (CMC) activities, we reduce risk, improve efficiency, and support regulatory compliance—delivering IND-ready material with greater speed and confidence.

Q: How fast can Lonza take my molecule from DNA to IND?

Timelines depend on the molecule type. For standard and high-concentration monoclonal antibodies (mAbs), bispecifics and Fc-fusion proteins, our DNA-to-IND program can deliver IND-ready material in as little as six months with toxicology drug substance available as early as two months. More complex molecules may require additional time, but all programs follow an accelerated milestone-driven workflow designed to support early regulatory engagement. *From DNA transfection to delivery of IND-enabling CMC modules. Typical timelines. Subject to agreement with regulatory authorities.

Q: Can Lonza provide non-GMP material for toxicology and early studies?

Yes. We offer rapid delivery of non-GMP drug substance and drug product for toxicology, stability, and other supportive development, with toxicology drug substance material available as early as two months for eligible programs. These materials are produced using stable pools or clonal cell lines within the same integrated workflow, allowing them to remain representative and comparable to future GMP batches. This supports earlier toxicology study initiation and helps de-risk investment decisions.

Q: How does Lonza manage CMC risk during DNA-to-IND development?

We mitigate CMC risk through early integration of drug substance and drug product development, robust analytical and process platforms, and proactive consideration of regulatory expectations. Our strategies include early formulation screening, comparability assessments, and platform-based purification and analytical methods. These measures help achieve a high-quality, compliant regulatory package while maintaining speed and flexibility.

Q: What regulatory support does Lonza provide during IND, CTA or IMPD preparation?

We provide comprehensive regulatory support including CMC documentation, method validation, comparability assessments, and strategic guidance tailored to global health authority requirements. Our regulatory packages typically include stability data, virus reduction studies, and simulated clinical administration testing. Our experienced teams help you meet regulatory milestones with high-quality data aligned to current standards.

6 months

from DNA sequence to IND/IMDP*

100+ molecules brought to market

Commercial molecules brought to market using GS System® technology

100% success rate

for IND-enabling CMC dossiers

Speed. Not setbacks.

More than 40% of IND application clinical holds are linked to CMC challenges.

You don’t have to give up speed or performance for reliability. Have it all with the right partner. We can accelerate your biologics development without adding risks through:

A proven cell line
Integrated drug substance and drug product workflows
Early tox study commencement
Lean process development
Platform and molecule-specific development approaches
Embedded automation and data-driven decision-making

Find the right pathway for your molecule

70% of our customers are biotech.
Here is what they have to say.

You explain. We listen. Then we make it work.

Julie Trulson of Asher Biotherapeutics discusses how Lonza was not only willing – but eager – to take on her team’s small-scale biotherapeutic manufacturing program, as well as the flexibility and expertise that went into building a proposal that was the right fit for Asher.

Because of our fusion proteins there were more elements that had to go into the proposal. There was more technical evaluation from their experts. At no point did they ever say: Oh we don’t think we can do that.

– Julie Trulson, Ph.D. Chief Executive Officer, Asher Biotherapeutics

Deep scientific expertise at your disposal

Simon Westbrook had an idea for a complex fusion chimera protein he believed could have a profound impact on chronic pain and joint degeneration in osteoarthritis patients. Lonza worked with him early on and the molecule is now in Phase II.

One of my goals at the very beginning was to work with the very best.

– Simon Westbrook, Founder & CEO, Levicept

Committed to customer satisfaction

Surrozen’s President & CEO, Craig Parker, discusses how the expertise, resources and flexibility of Lonza have been fundamental in advancing its novel and complex bispecific antibody candidates that target the WNT pathway.

Would we choose Lonza again? I would say absolutely.

– Craig Parker, President & CEO, Surrozen

Adding value to every program

Alicia Levey and Kiren Khanduja of Pionyr Immunotherapeutics discuss the basis for selection of Lonza to meet Pionyr’s goals to rapidly develop a third lead candidate from the start and to scale-up manufacturing of two clinical-stage immuno-oncology treatments after tech transfer.

We felt that a partnership with a single CDMO that has a fully integrated, end-to-end solution and strong technical capability would allow Pionyr to optimize our resources and remain lean.

– Alicia Levey, Ph.D., Chief operating officer, Pionyr Immunotherapeutics

Complexity is not a barrier with the right partner

~40 % of our molecules are non-mAbs
~40 years of solving biologics challenges others avoid
First CDMO to manufacturing an IgE at scale

What we needed to achieve had never been done before. Lonza was not only willing to engage with us, its team was motivated to take on this novel challenge.

– Tim Wilson, Ph.D. Chief Executive Officer, Epsilogen

Not just a brand. A promise.

Corvus is a small biotech developing a monoclonal antibody for oncology patients. Lonza started work with available capacity in Singapore and then transferring to Slough, UK. The product is currently in clinical trials.

Lonza’s brand name is a crucial factor that is particularly valuable for smaller biotechs, it lends credibility and provides comfort to investors and regulators.

– William B. Jones, Ph.D., Senior Vice President of Pharmaceutical Development, Corvus Pharmaceutical

Flexible solutions that move at your pace, across every stage of development.

Biologics development isn’t one-size-fits-all. Some programs might need to move as fast as possible to IND-readiness. Others might require a more milestone-driven approach, aligned to funding events, portfolio priorities, or specific technical risks.

Our integrated DNA-to-IND programs provide a faster, end-to-end path to bring your molecule to clinic.

For a milestone-based approach, you can either rely on Lonza’s expression platform or transfer your established cell line or process at any stage:

Vector construction and manufacturability assessment
DNA to tox DS or DP batches
DNA to RCB or MCB
Transfer of an established cell line or process
Development starting from bulk drug substance or purified product

From there, programs can continue to progress towards IND as integrated DS/DP programs, or remain modular and milestone-driven as your needs evolve.

Faster timelines for key IND milestones
Early de-risking in <11 weeks	DNA to tox in 2 months	DNA to IND in as little as 6 months^*	30% with expedited review designation
Higher performance for long-term success
Across standard and more complex biotherapeutic protein formats	2000+ molecules expressed with GS System® technology since 2012	Up to 9g/L titers	Scalable process
Deeper expertise to deliver with reliability
160+ IND/IMPD	100+ commercial products made using our GS System® technology	40+ years of experience in biologics	0 programs on clinical hold due to CMC

^* From DNA transfection to delivery of IND-enabling CMC modules. Typical timelines. Subject to terms and conditions.

DNA-to-IND for mAbs in as little as 6 months

Accelerate your standard and high-concentration monoclonal antibody development with our DNA-to-IND program designed for speed, quality and confidence.

Our integrated workflow brings together cell-line, process, and formulation development to deliver IND-ready material in as little as 6 months. By aligning drug substance and drug product development early, we reduce risk, eliminate bottlenecks, and maintain quality at pace.

Learn how our proven mAbs DNA-to-IND workflow unites cell line, DS and DP development to enable tox material supply in 2 months, and a complete IND-enabling CMC package in 6-8 months*.

DNA-to-IND program for bispecifics in as little as 6 months

Bispecific antibodies present unique challenges in expression, assembly, purification and formulation. Our accelerated DNA to IND pathway combines molecule-specific development strategies with an integrated workflow to help bring standard and high-concentration bispecific antibodies to IND in as little as 6 months.

Discover how our bispecifics DNA-to-IND program helps developers reach IND in as little as 6 months.

DNA to IND programs for Fc-fusion proteins in as little as 6 months

Fc-fusion proteins require tailored development strategies to support expression, product quality and manufacturability. Our DNA-to-IND program helps bring standard- and high-concentration Fc-fusions to IND in as little as 6 months.

Explore DNA-to-IND pathways for Fc-fusion proteins.

Fab fragment DNA-to-IND programs

Fab fragments require specialized strategies to achieve yield, stability and scalability. Our integrated workflow aligns drug substance and drug product development to simplify CMC, reduce rework and support IND readiness.

See how our DNA-to-IND program helps you manage expression challenges effectively and reach the clinic with confidence.

Tailored solutions for scaffolds and other recombinant proteins

Non-IgG scaffolds and other recombinant proteins often face unpredictability in expression, purification and formulation. Our DNA-to-IND program adapts established biologics workflows with tailored process design and analytics to de-risk development.

Learn how our flexible approach helps advance novel modalities efficiently to IND.

Frequently Asked Questions

What is a DNA-to-IND program, and how does Lonza support it?

Our DNA-to-IND program is a fully integrated offering that accelerates the path from DNA sequence to Investigational New Drug (IND) submission. It brings cell line development, process and formulation development, analytical testing, and regulatory documentation together in a single workflow. By minimizing handovers and aligning all Chemistry, Manufacturing, and Controls (CMC) activities, we reduce risk, improve efficiency, and support regulatory compliance—delivering IND-ready material with greater speed and confidence.

How fast can Lonza take my molecule from DNA to IND?

Timelines depend on the molecule type. For standard and high-concentration monoclonal antibodies (mAbs), bispecifics and Fc-fusion proteins, our DNA-to-IND program can deliver IND-ready material in as little as six months with toxicology drug substance available as early as two months. More complex molecules may require additional time, but all programs follow an accelerated milestone-driven workflow designed to support early regulatory engagement. *From DNA transfection to delivery of IND-enabling CMC modules. Typical timelines. Subject to agreement with regulatory authorities.

Can Lonza provide non-GMP material for toxicology and early studies?

Yes. We offer rapid delivery of non-GMP drug substance and drug product for toxicology, stability, and other supportive development, with toxicology drug substance material available as early as two months for eligible programs. These materials are produced using stable pools or clonal cell lines within the same integrated workflow, allowing them to remain representative and comparable to future GMP batches. This supports earlier toxicology study initiation and helps de-risk investment decisions.

How does Lonza manage CMC risk during DNA-to-IND development?

We mitigate CMC risk through early integration of drug substance and drug product development, robust analytical and process platforms, and proactive consideration of regulatory expectations. Our strategies include early formulation screening, comparability assessments, and platform-based purification and analytical methods. These measures help achieve a high-quality, compliant regulatory package while maintaining speed and flexibility.

What regulatory support does Lonza provide during IND, CTA or IMPD preparation?

We provide comprehensive regulatory support including CMC documentation, method validation, comparability assessments, and strategic guidance tailored to global health authority requirements. Our regulatory packages typically include stability data, virus reduction studies, and simulated clinical administration testing. Our experienced teams help you meet regulatory milestones with high-quality data aligned to current standards.

Start the conversation

Ready to take the next step toward IND? Complete the form and one of our experts will be in touch to discuss your program goals, answer your questions, and explore how Lonza's integrated DNA-to-IND solutions can help you move from sequence to clinic — faster, and with confidence.