Build your development and manufacturing path to IND
Flexible | Bespoke | Milestone-based
The IND journey is complex, risky and resource straining. A large amount of data must be generated and interpreted and many of the steps are carried out in parallel but rely on the results from previous steps for an optimal outcome.
One of the key considerations is to optimize the use of your early phase material and to do so, build your pre-clinical development and manufacturing path in line with your key IND milestones. You may decide to take a stepwise approach and pause at different manufacturing stages, for example at non-GMP manufacturing, RCB, MCB and/or toxicology testing enabling material, allowing you the read-out of safety and efficacy studies or applying for additional rounds of funding. You may wish to take an accelerated CMC path without breaks from DNA-to-IND and run activities as much in parallel as possible.
Download our white paper and find out how to maximize the value of early phase material and match your manufacturing path to your IND milestones
At Lonza, we understand the complexity of building a development and manufacturing path to IND. This is why we offer a flexible approach to shape together a program that is in sync with your molecule’s profile and company’s needs. You can also bring in your own cell line at any stage of your journey.
A few examples of how your path can look:
In silico and in vitro manufacturability assessment
Vector construction
From MCB to GMP drug substance or drug product
From DNA to RCB or MCB
From DNA to tox drug substance or drug product
From DNA to IND-enabling CMC activities