After years of hard work, your molecule deserves the best chance of success. We know the path to market can be complex and costly.
Leverage our expertise and network to launch at the right scale and time for a smooth market entry.
5 reasons to partner with Lonza
Expertise when it matters most: Achieve seamless, timely launches with our team of experts leveraging cutting-edge technologies to consistently and efficiently deliver the highest quality standards and regulatory compliance.
On time, in full delivery.
Scale up when it matters most: With a comprehensive set of production assets, we help you manage uncertainty and adapt to unpredictable product supply conditions.
Right-size your market entry with the ability to seamlessly scale when you need it.
Flexibility when it matters most: We understand your commercial situation and co-create solutions to meet your needs and goals.
Quality outcome delivered with enhanced efficiency.
Simplicity when it matters most: As a fully integrated CDMO, we manage supply chain complexity and provide a fast, cost-efficient solution.
Enhanced agility and risk mitigation.
Partnership when it matters most: We support you across your molecule's lifecycle with our integrated and flexible capabilities, regulatory strategy, and CMC experience.
As a pure-play CDMO, your success is our success.
A structured CMC approach
We match our approach to your product, process, timeline and risk tolerance.
The Drug Substance and Drug Product packages are tailored according to:
Your key milestones
- Pivotal study readout date
- Clinical urgency and expedited status
- Planned submission date
Your material requirements
- Clinical re-supply
- Initial launch supply
Your commercial supply strategy
- Initial supply site
- Subsequent supply site (if required)
A comprehensive data package
The CMC data package encompasses analytical development and method validation, small-scale process characterization studies, GMP validation batches (PPQ batches), process validation studies and product-related analytical studies. A combination of small-scale and large-scale experimentation is used to establish scientific evidence that a process is capable of consistently delivering quality products.
Our network
Building confidence
We have an extensive content library to show you why Lonza can help you launch with confidence.
Select the category you're interested in and browse some resources we think are particularly helpful.
Drug Substance
The Right Scale at the Right Time to Accelerate Your Market Supply
What do You Need to Know to Navigate the ‘Now What?’ After Early-Phase Success?
Tech Transfer Strategies and Best Practices to Optimize Your Clinical and Commercial Supply
Drug Product
Mastering Biologics Tech Transfers: Key Success Factors
How Can You Ensure Successful Late-Phase Development And Launch Of Your Biologic Drug Product?
A proven track record
Launch with confidence
- 150+ Tech Transfers
- 45+ BLA
- 100% success rate for BLA-enabling CMC dossiers
Right amount of material on time
Scale up with confidence
- A global network of bioreactors from 1kL to 25kL that can handle high-titer processes
CDMO collaboration that delivers
Partner with confidence
- 55+ commercial products supported (more than any other CDMO)
Get ready to launch
Get in touch with us to leverage our expertise and network.
Launch at the right scale and time for a smooth market entry.
Start the countdown by talking to our experts
