Integrated Biologics Development Services

710+ pre-clinical and clinical large molecules

~40% of programs are complex molecules

0% of our programs on clinical hold due to CMC

Right first time. Ready for what is next.

Biologics development is where early decisions define long-term success.

Through our biologics CDMO services, we bring together drug substance and drug product expertise from the start, helping you make informed choices that reduce risk and create a strong, scalable foundation, from the first clinical batch through to commercialization.

By integrating cell line, analytics, process, and formulation development with end-to-end thinking, we align complex workflows across your program. This integrated biologics development approach improves consistency, supports regulatory readiness, and enables efficient progression to larger-scale manufacturing.

We adapt to your starting point while designing development that supports future manufacturing, achieving continuity and confidence as your program advances.

Deep expertise across molecule types and drug product formulation

Developing new biologics requires careful alignment between molecule design and drug product requirements. From monoclonal antibodies to complex modalities, each molecule presents unique challenges across expression, purification, analytics, formulation and quality.

We integrate drug substance and drug product development from the beginning, aligning process design, analytics, and formulation to meet GMP, quality and performance requirements.

This connected approach:

Reduces downstream risk
Supports consistent product quality
Accelerates development timelines
Enables scalable, robust processes across modalities.

Want to learn more? Watch our recent on-demand webinar

As biologics drug product development becomes more complex, early decisions carry greater risk. Drawing on experience across more than 70 bispecifics programs, we understand the common challenges in analytics, purification, and formulation that can delay timelines or affect regulatory readiness. Our experts help you identify these risks early, supporting faster, more reliable progression in this webinar.

Watch the on-demand webinar

Analytical development

Analytical insight is critical to making the right decisions early. We align analytical development across drug substance and drug product, combining platform approaches with product-specific methods into phase-appropriate control strategies. This enables a clear understanding of critical quality attributes and supports consistent product quality and stability throughout development.

Working closely with you, we provide the data and insight needed to define control strategies, assess product quality, and support confident regulatory submissions.

Cell line development

Achieve a seamless transition from cell line development into cGMP manufacturing with a strong process that starts with the right cell line. We combine proven expression technologies with decades of experience to generate stable, high‑producing cell lines with desired product characteristics, optimized for your molecule and ready for manufacturing.

By focusing on performance, reliability and scalability from the start, we help you accelerate timelines while building a foundation that supports clinical and commercial success.

Formulation development

For many biologics, formulation determines whether a molecule can reach patients at all. Our experts help address potential stability, concentration, and delivery challenges and offer suitable drug presentations to customers, such as lyophilization and advanced injection formats.

Having integrated expertise across drug substance and drug product development is a critical factor to avoid reformulation, uphold product quality, and deliver a drug product ready for clinical and commercial supply.

Biologics process development

Our SMEs design and optimize your process by defining and characterizing critical process parameters early, establishing processes that are reproducible, transferable, and built to deliver consistent quality from clinical supply through to commercial manufacturing.

We combine proven platform approaches with cutting-edge technologies, including lyophilization cycle development, to enable robust and scalable manufacturing solutions.

Frequently Asked Questions

How can I get my biologic to IND faster without increasing development risk?

Speed trade-offs are common concern, especially for early and clinical stage programs. That is why we integrate drug substance and drug product development early, aligning process, formulation, analytics, and regulatory readiness with tailored DNA-to-IND programs. This not only helps mitigate rework and late surprises, but helps accelerate timelines while maintaining robustness as programs move toward IND.

How does Lonza help me stay in control and informed during development?

Customers value transparency as much as execution, while development decisions are only as good as the data and visibility behind them. Our SMEs offer expert guidance and phase‑appropriate data packages to provide transparency on progress, risks, and next steps. This keeps you informed, confident, and in control throughout your program.

Can I start development at a specific stage and still scale later without changing partners?

Yes. You can engage with our experts at any stage—from early development through clinical or commercial drop‑in. Whether you bring an existing cell line, process, or drug product, we adapt to your starting point and design development activities with future scale in mind. Combined with our end-to-end manufacturing capabilities, this allows you to scale smoothly to commercialization without re‑starting or switching partners.

How does Lonza help manage CMC risk in early development?

Early CMC risk often stems from avoidable design mistakes, poor data continuity, or fragmented development. Our proven technology platforms, combined with integrated DS/DP expertise help de‑risk key early choices and build data packages that support regulatory interactions and later tech transfers.

Learn more about our early de-risking and optimization.

How does Lonza support programs with limited internal CMC or regulatory expertise?

Many early and growing biotech teams rely on external expertise to move fast with confidence. Our SMEs would act as an extension of your team by providing scientific guidance, regulatory insight, and clear recommendations to help you find solutions and make informed decisions at each step.

The right location; the right scale

We continuously invest to expand our global network to serve you where you need it.

Explore all locations