Advance your molecule to IND from simple to complex
Over the last few decades, there has been a large shift in drug development pipelines towards more complex, next generation biologics to tackle unmet medical needs.
At Lonza, we have decades of experience in developing and manufacturing any molecule type, however we are continuously addressing our customers’ needs and growing our portfolio of solutions to support their therapeutics, from simple mAbs to new molecular formats.
Related content
Explore related content to learn more about our tailored CMC strategies
We offer a full suite of integrated Drug Substance/Drug Product DNA-to-IND programs to accelerate any molecule type to the clinic.
Monoclonal antibodies
In this white paper, we explore how we are able to guarantee customers five months from DNA to tox drug substance, and 11 months to Investigational New Drug designation (IND) filing for antibodies, using its Ibex® Design 2.0 Program.
Bispecific antibodies
This white paper will highlight key approaches and technologies that enable this timeline. Case study examples will be shared for application in vector, process, analytic and formulation development of bispecific molecules during pre-clinical development.
Scaffolds & recombinant proteins
In this white paper, we share our integrated drug substance and drug product CMC strategy, along with technical case studies from process and analytical development that provide insight into how we have delivered tailored product-specific solutions and enabled the acceleration of novel molecular formats into the clinic.
Fabs & Fc-Fusion proteins
This webinar shares Lonza's integrated drug substance and drug product CMC strategy, along with technical case studies from process and analytical development that provide insight into delivering tailored product-specific solutions.
Building your CMC path to the clinic, for any molecule type, becomes easier when working with a flexible partner
- Speed to clinic through bespoke integrated drug substance/drug product programs
- Take your molecule step-by-step to the clinic, pausing after key milestones
- Bring in your own cell line at any stage of your journey
Do you need a personal consultation? Get in touch and talk to our experts.
Lonza can support your manufacturing needs from early development to commercialization. For more information, please visit our website.
1 From DNA transfection to Delivery of IND-Enabling CMC Modules.
2 Subject to terms and conditions
3 Typical timelines, subject to molecule evaluation
4 For antibodies, from DNA transfection to delivery of IND-enabling CMC modules. Subject to terms and conditions.
