Early insight for better decisions
Generate the data needed to identify hidden liabilities, optimize candidates and build confidence before major development investment.
20+ years
Helping customers de-risk molecules, prioritize candidates and advance development programs.
Integrated assessment toolbox
Comprehensive in silico and in vitro capabilities spanning manufacturability, immunogenicity, expression, humanization and formulation readiness.

De-risking drug development and therapeutics before IND

Every development decision carries consequences for timelines, budgets, future milestones and, ultimately, success in the clinic.

Before advancing a lead candidate, understanding potential manufacturability, immunogenicity, expression, formulation and overall developability risks can help reduce uncertainty and avoid costly surprises later in development.

Early assessment helps identify these risks when they are easier and less costly to address, helping you build greater confidence before IND for your next board meeting, investors and partnership opportunities.

Our Early Development Services combine in silico and in vitro assessment, optimization and protein production capabilities to help you better understand and advance promising candidates with greater confidence.

Learn more about early de-risking

Five things to
know before IND
That you can make enough of it.

Will it express in the intended platform?

Even a breakthrough molecule still needs enough material to move forward. Understanding expression potential early helps determine whether a viable production path exists before development advances.

If hidden liability could slow the path ahead.

Can it be optimized?

The best biological candidate isn't always the best development candidate. Early developability insight can help identify liabilities before they shape the path ahead.

That you can manufacture it.

Can you manufacture it?

Manufacturing challenges often emerge long before manufacturing begins. Understanding them early can help reveal constraints, support smarter decisions and reduce downstream surprises.

How the immune system may see and react to your candidate.

How will the immune system respond?

Immunogenicity remains one of the leading causes of clinical failure. Some liabilities only become visible when the immune system responds. Assess early.

If formulation could become a bottleneck.

Is it formulation ready?

Not every molecule can meet the product profile you envision. Early formulation insight helps identify constraints before they become development challenges.

Protein expression

Will your molecule perform in the system you intend to manufacture it in?

Using an expression platform for early development that differs from the one ultimately used for cell line development and manufacturing can introduce unnecessary rework, development challenges and delays.

Our teams help you generate critical expression data and protein in the same platform intended for later development and manufacturing. By carrying forward key learnings, including expression levels (titer), product quality attributes, vector design and purification insights, you can make more informed candidate selection decisions, reduce development risk, and establish a stronger foundation for cell line development.

Candidate optimization: Protein engineering and humanization

What stands between your molecule today and its full potential?

Sequence-related liabilities can affect developability, manufacturability and overall molecule performance throughout development.

We help improve candidate profiles through targeted protein engineering and antibody humanization strategies. Whether addressing manufacturability challenges, reducing potential immunogenicity concerns or optimizing molecule performance, early engineering interventions can strengthen candidate quality and help support progression toward the clinic with greater confidence.

Manufacturability assessment

How manufacturable is your molecule?

Manufacturing challenges that go undetected early can lead to process complexity, scalability limitations and costly development setbacks later.

As part of our drug development services, we help assess developability attributes that may influence manufacturing success, process robustness and scalability. Early insight into manufacturability risks can help identify hidden liabilities before significant development investment is made, enabling more informed candidate selection and reducing the likelihood of downstream challenges.

Early Development Services - Manufacturability
Epibase® Immunogenicity Assessment

How might your molecule interact with the human immune system?

Immunogenicity and/or immunosafety risks discovered late can introduce uncertainty, require additional mitigation strategies and impact development plans.

Assess potential T-cell-mediated immune responses using Lonza’s proprietary Epibase® platform. Understanding immunogenicity and/or immunosafety risk early can support candidate selection, guide protein engineering strategies and help inform risk mitigation plans.

Formulatability

Is your molecule ready for its intended formulation?

Formulation challenges identified late can require additional development work, reformulation efforts and timeline adjustments.

Integrating formulatability testing into your early drug development strategy enables prompt identification of potential stability, solubility, and delivery challenges. Understanding these properties prior to lead nomination can help guide candidate selection and reduce the need for future reformulation efforts.

Early de-risking, now even more accessible

Detect key manufacturability, stability, immunogenicity and immunosafety risks early, within a coordinated framework, and produce your molecules in Lonza's trusted GS Gene Expression System® platform.

Build a strong, comprehensive data package that stands out, increases investor confidence, supports IND readiness and protects the long-term value of your asset.

See what's included

Related Offerings
Developability Assessment
Our Developability Assessment Toolbox is a suite of in silico tools and applied protein structure expertise to derisk mammalian and microbial-derived...
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Manufacturability Assessment
We offer proprietary in silico tools for biologics manufacturability assessment, including analysis of post-translational modifications and...
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Biologics Formulatability
Early de-risking of drug development involves assessing molecular liabilities that can negatively impact drug product stability, quality, and patient...
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Immunogenicity / Immunotoxicity Assessment
Access our immunogenicity and immunotoxicity assessment services; address unwanted immune responses throughout the drug development cycle.
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​​Early Protein Expression​​​ Services​​
Select the optimal expression system for your biotherapeutic protein production. Express milligram to low gram quantities of non-GMP material for your...
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Our locations
Locations where these services are provided
Cambridge, United Kingdom
Cambridge, MA, USA
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Frequently Asked Questions

Lonza offers end-to-end early drug development services designed to evaluate, optimize, and de-risk biologic candidates prior to IND submission. Our capabilities combine in silico and in vitro assessments with protein engineering, humanization, protein expression, manufacturability, immunogenicity and formulatability evaluations to support informed development decisions and reduce downstream risk.

Early assessment can help identify potential developability challenges related to manufacturability, immunogenicity, expression and formulation before significant development investment is made. By addressing these risks earlier, teams can make better candidate selection decisions, reduce uncertainty and build greater confidence as programs advance toward IND.

Yes. We support biologics programs from early candidate assessment and optimization through critical preclinical development activities that help prepare candidates for IND submission. Our integrated approach helps maintain development momentum while reducing complexity during key program transitions.

We help answer important developability questions, including whether a candidate can be manufactured efficiently, whether it may trigger unwanted immune responses, whether protein engineering or humanization could improve performance, and whether formulation or expression challenges could impact future development.

We combine multiple early development capabilities within a single integrated offering, bringing together in silico and in vitro assessment, optimization services and protein production expertise. With 20 years of experience and over 2,000 developability profiles assessed, we help our customers make informed decisions earlier in development.