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  • Bispecific Antibodies DNA-to-IND Program

Bispecific Antibodies
DNA-to-IND Program

For bispecific antibodies, we offer an integrated drug substance and drug product DNA-to-IND program with reliable timelines backed by our 35 years' experience in biologics.
Talk to our experts
13 months* from DNA to IND.
7 months* from DNA to Tox drug substance.
8.5 months* to Tox drug product.
Tailorable technical scope and timelines when necessary to meet your material and development needs.

Take your bispecific antibody from DNA to tox drug substance in only seven months* and IND in 13 months*

As biotech companies look to realize the full potential of bispecific drug candidate and make it market-ready, it is essential to find appropriate expression technologies and development processes that can accelerate their path to clinic and support a smooth and scalable manufacturing process.

Building on a decade of experience, we have created and optimized a workflow with platform, processes and analytics using a solid risk-based approach to track activities in parallel during the DNA-to-IND process, enabling reduction of timelines without increasing risk. 

This integrated drug substance and drug product approach enables us to take your bispecific antibody from DNA to IND in only 13 months*. If you are looking to obtain comprehensive information on your drug candidate as early as possible, we deliver tox drug substance in only 7 months* so that you can perform toxicological studies before entering GMP manufacturing.

*From DNA transfection. Subject to terms and conditions.

Power your bispecific into the clinic with our global technical expertise

We use pre-defined project gates and technical forums to manage successful CMC programs and proactively identify and mitigate technical risks as soon as possible.

Project gates are pre-defined based on our experience and drive a cross-functional, data driven approach for our customer’s project.

Risk levels can be tailored based on customer timeline requirements and tolerances.

Our experienced Senior Technical Leads in the UK and west coast US as well as our Drug Product Technical Experts in Switzerland are available to support proposals and project teams with in-depth technical and CMC knowledge for drug substance and drug product.

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Related Insights

Knowledge Center
Presentation (on-demand)
CMC Strategy to take Bispecifics from DNA to IND in 13 Months
Lonza has applied it's 35 years of CMC experience in Biologics to develop an end-to-end...
Whitepaper/Executive Summary
De-risk Development and Manufacture of Bispecific Antibodies with Lonza
In this executive summary you'll discover why we are the CDMO to turn to when you want a faster path...
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Knowledge Center

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29 Mar 2023
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Lonza Completes Clinical and Commercial Drug Product Manufacturing Line in Visp (CH)
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29 Mar 2023
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Lonza Completes Clinical and Commercial Drug Product Manufacturing Line in Visp (CH)
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29 Mar 2023
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Lonza Completes Clinical and Commercial Drug Product Manufacturing Line in Visp (CH)
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16 Feb 2023
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16 Feb 2023
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Lonza Completes Expansion of Conjugation Facility in Visp (CH)
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16 Feb 2023
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Lonza Completes Expansion of Conjugation Facility in Visp (CH)
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13 Feb 2023
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Lonza to Expand Early Development Services Offering into North America
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