A defensible CMC package, built on evidence.

Plan comparability studies, assess biosimilarity, and converge on robust formulations with workflows grounded in regulatory guidance and your analytical data.

Built for: CMC leads, Analytical scientists, Formulation teams

Challenges

• Comparability plans start from scratch: Every program re-derives which critical quality attributes matter and which orthogonal methods are needed to defend them.
• Regulatory expectations keep moving: Mapping FDA, EMA, and ICH guidance onto a specific molecule and change scenario is expert work that doesn't scale.
• Formulation is trial and error: Excipient screens and stability studies are expensive, and the reasoning behind each choice rarely gets written down.

What LiteFold does

• Analytical comparability planning: Identify critical quality attributes, select methods, and draft a study design that anticipates regulatory questions.
• Biosimilarity assessment: Assemble a totality-of-evidence case that ties analytical, functional, and clinical data to the reference product.
• Glycosylation and higher-order structure: Reason over glycan profiles, charge variants, and aggregation data to flag comparability risks early.
• Formulation development advisor: Recommend excipients, buffer systems, and stability study designs with the supporting literature attached.