Material Characterization Services

DRUG CHARACTERIZATION AND PREFORMULATION SERVICES THAT DRIVE DEVELOPMENT FORWARD

A strong drug development program starts with a clear, practical understanding of your molecule. Our drug characterization and preformulation services generate the fundamental physical and chemical insight needed to inform formulation strategy, analytical development, and long term manufacturing decisions.

Our teams work as an extension of yours, tailoring experimental plans to your program’s phase, molecule type, and risk profile. We focus on answering the right questions at the right time, enabling confident decision-making while preserving valuable material.

Backed by deep analytical and biophysical expertise plus decades of early-stage development experience, we support a wide range of modalities, from small molecules to complex and emerging drug entities. Our broad expertise, combined with phase-appropriate rigor, allows us to adapt as programs evolve, priorities shift, or new data emerges.

MATERIAL CHARACTERIZATION SERVICES

Our teams help generate a fundamental understanding of therapeutic physicochemical properties to drive phase-appropriate method development. This evaluation highlights key material attributes to characterize or identify lead candidates, support formulation development, and key stability insights.

Drug Characterization and Preformulation Screening

Proactive screening can help identify the best opportunities for delivering your drug substance most effectively.

Solid state characterization: Predict and avoid long term challenges with physical stability
Polymorph screening: Discovery of different crystalline forms; important for stability and intellectual property
Salt screening: Identifying salt forms to improve solubility/stability
Co-crystal screening: For non-ionized APIs, improving formulation options
Solubility testing: Avoid undesirable PK profiles and efficacy issues
Stability studies: Evaluate environmental influences, degradation pathways, and surface-solvent reactions
Excipient compatibility: Compare excipient options and define boundary conditions

Preclinical Development

Establish a data package to inform candidate(s) selection as you approach CMC development.

Dosing vehicles: Conduct ADME/pharmacokinetic studies, assess safety and toxicology, and create your clinical formulation
Test articles: Prepare, test, and ship your test articles from our laboratories with our specialized technology
Custom analysis: From minimal screening to complete characterization, our solutions are suited to your lead candidates

Phase-Appropriate Analytical Support

Analytical characterization strategies aligned to your development stage, ensuring rigor without unnecessary complexity or delay.

Support for Diverse and Emerging Modalities

Experience characterizing a wide range of drug entities, including novel and complex molecules, with an understanding of evolving regulatory expectations.

Strategic Development Insight

Collaborative development across formulation and analytical teams to ensure characterization data directly informs downstream decisions.

Material-Sparing Early Development Strategies

Efficient study design that delivers meaningful insight while conserving scarce or costly material.

Analytical and biophysical characterization

Drug substance
Drug product
Novel molecules
Impurities

Drug substance

Drug substance characterization offers insight into your target therapeutic’s safety, efficacy, and developability.

Purity methods: Apply a strategic combination of approaches to evaluate control of critical quality attributes
Conformation: Assess nucleic acid conformation in different solutions and temperatures
Molar extinction: Determine the water and sodium content of synthetic oligonucleotides to get a reliable extinction coefficient
Identity methods: Confirm molecule identities with sequence mapping, sequencing, and primer-based techniques

Drug product

Push beyond routine identity, purity, assay, and safety testing with advanced, customizable drug product characterization studies.

Lipid nanoparticles: Determine size distribution, zeta potential, encapsulations efficiency, and composition ratios
Particle capsid: Explore protein composition, post-translational modifications, plus viral particle size and composition

Novel molecules

Discover critical properties for novel molecules despite complexity made possible by our diverse experience and a variety of analytical methods. Our experience and capabilities support molecules such as antibody-drug conjugates (ADCs), polymer-drug conjugates, and monoclonal antibodies (mAbs).

Impurities

Impurities characterization includes screening and risk assessment, method development and validation, and ongoing monitoring aligned with allowable limits.

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Understanding Polymorphism to De-Risk Drug Development

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Drug development services, built for progress