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Integrated Drug Substance and Drug Product Manufacturing

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70+ commercial large molecules
supported through trusted, end-to-end biologics manufacturing expertise.
300+ successful tech transfers
delivered to support your program's evolving needs.
Process innovation and advanced technologies
that strengthen cGMP performance.

CMC outsourcing with built in reliability

Biologics manufacturing allows little margin for error. Process deviations, supply disruptions, operational gaps, or regulatory changes can quickly lead to delays—impacting timelines, reputations and ultimately patients.

We provide integrated drug substance and drug product manufacturing designed to help reduce CMC risk, support regulatory compliance, and simplify your supply chain.

Based on your molecule’s needs and development priorities, you can leverage our global network, deep biologics manufacturing expertise, and integrated capabilities to meet your development goals. From efficient technology transfer and compliant manufacturing to reliable, on-time clinical and commercial supply close to patients worldwide, our offering is tailored around what you need, when you need it. 

 

Discuss your manufacturing needs

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Advanced manufacturing technologies for your commercial success

Quality you can trust

As a leading integrated drug substance and drug product CDMO, ensuring quality at the manufacturing stage is about experience, consistency, transparency and readiness. Our quality systems and teams support reliable execution, regulatory compliance, inspection preparedness, and patient safety throughout your product lifecycle.

"What excites me and the team about working with customer products is the chance to do something new and be part of bringing something to patients."

Steve Dawson, Head of Quality, Lonza Vacaville

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Integrated drug substance manufacturing

Our mammalian manufacturing services support pre-clinical through commercial drug supply with the right scale at the right time.

We offer single-use bioreactor technologies up to 2000L scale and stainless-steel bioreactors from 6000L to 25000L, to support your product through its lifecycle and respond with agility to changing product demand.

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Biologics drug product manufacturing

We provide integrated, GMP‑compliant drug product manufacturing to support clinical and commercial supply.

Our services are aligned with your molecule, dosage form and presentation strategy, and are designed to meet global regulatory expectations. Integrated with upstream development and our drug substance network, we help streamline transitions, reduce CMC risk and deliver consistent high-quality supply.

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Webinar: Integrated drug substance and drug product manufacturing


Watch this on-demand webinar to learn how integrating drug substance and drug product manufacturing within Lonza’s CDMO framework can streamline biologics development.

Lonza experts share insights from cross-site drug substance and drug product programs, showing how integration improves coordination, strengthens quality, and supports successful regulatory outcomes.

Watch the webinar on demand
The right location; the right scale
We continuously invest to expand our global network to serve you where you need it.
Vacaville, CA, USA
Portsmouth, NH, USA
Visp, Switzerland
Stein, Switzerland
Slough, United Kingdom
Porriño, Spain
Singapore
Explore all locations
Frequently Asked Questions

Our fully integrated commercial DS/DP setup eliminates inter‑manufacturer interfaces, reducing variability and strengthening supply reliability. DS and DP sites operating under one quality system allows for consistent commercial performance, while transparent governance and robust KPIs provide end‑to‑end supply visibility. The simplified supply chain – enhanced by sustainability‑driven operational practices – supports long‑term, compliant, and responsible procurement.

As an end-to-end biologics manufacturing CDMO, we’re equipped to support you as your drug manufacturing requirements increase. We operate large‑scale bioreactors up to 25kL across our drug substance network, paired with high‑throughput drug product lines for vials, lyophilized products, pre-filled syringes (PFS), and cartridges – enabling long‑term supply security even for high‑demand products.

Yes. Our network supports simultaneous launches across major regions, including the US, EU, and Asia, with established logistics, validated shipping routes, and extensive regulatory experience.

We have a strong track record of 80+ successful site inspections by 14 different global health authorities, such as the FDA and EMA in the last 5+ years. Our sites operate under a harmonized cGMP quality system with ongoing inspection readiness, keeping up to date with evolving regulatory requirements and standards.

Yes. Our more than 40 years of expertise in the biologics space enables us to deliver more efficient quality-focused tech transfer processes, while strictly adhering to cGMP standards. MSAT and regulatory teams routinely execute commercial‑scale technology transfers, PPQ activities, comparability assessments, and global post‑approval variations. With more than 300 successful tech transfers across our network, we are well-positioned to support you.