Bioanalytical Strategy for Complex Molecules: What Sponsors Should Consider at AAPS PharmSci 360 2026

Bioanalytical programs are becoming more complex as pharmaceutical developers advance multispecific antibodies, cell and gene therapies, and other sophisticated molecules. These programs can require assays that go beyond established platforms and methods to answer specific questions about mechanism of action, biomarkers, pharmacokinetics, immunogenicity, safety, and drug activity.

For sponsors, the challenge is not limited to developing an assay. The bioanalytical strategy must identify which questions need to be answered, determine which assays are necessary to answer them, account for development and validation timelines, and establish how the resulting data will support regulatory and development decisions.

These considerations will be central to conversations with Smithers Pharmaceutical Development Services at AAPS PharmSci 360, taking place October 25–28, 2026, in New Orleans, Louisiana.

President Christina Satterwhite and Senior Director of Business Development Connie Scott will represent Smithers Pharmaceutical Development Services throughout the conference at booth 1205, where sponsors can discuss complex bioanalytical programs, novel assay requirements, biomarkers, development timelines, and other challenges affecting their programs.

Complex Molecules Require More Targeted Bioanalytical Strategies

Many development programs no longer involve a single, well-characterized molecular target that can be evaluated through a conventional assay.

Multispecific molecules, for example, can require developers to understand the activity of individual components as well as the behavior of the combined molecule. A bioanalytical strategy may need to address how different components interact with a test system, how each component contributes to the overall mechanism of action, and which analytical questions are necessary to support development.

This complexity can make established assay approaches insufficient.

Smithers Pharmaceutical Development Services supports bioanalytical development for large molecule therapeutics across development phases and therapeutic modalities, including assay development, validation, and sample analysis.

For programs involving novel mechanisms or less-established analytical approaches, the first question may not be which existing assay to use. The more important question may be what the assay needs to demonstrate.

Novel Assays Need to Answer the Right Questions

Non-routine assays can be important during early development when sponsors are evaluating lead candidates or investigating mechanism of action. These assays can generate information that helps characterize a molecule and determine which candidate should advance.

The difficulty is that novel assays may lack the established history of more conventional analytical methods. Sponsors may need to determine whether an assay is technically feasible, what level of performance is necessary, how the resulting data should be interpreted, and whether the method will ultimately provide information relevant to development or regulatory requirements.

An assay can generate scientifically interesting information without being necessary for a specific development decision.

A well-planned bioanalytical strategy separates required questions from additional scientific questions that may be useful but are not essential to a regulatory or safety objective. This distinction can help sponsors avoid spending time developing assays that add information without advancing the program.

Bioanalytical Strategy Should Begin Early

Early planning becomes particularly important when assay development depends on specialized reagents or other materials with extended lead times.

Critical reagents can require six months to a year or longer to develop. Delaying decisions about assay requirements can therefore create downstream schedule constraints that are difficult to recover.

Early bioanalytical planning allows sponsors to identify the assays needed for preclinical and clinical development, establish development and validation requirements, assess reagent needs, and consider how the resulting data will support regulatory discussions.

The strategy also needs to account for the relationship between bioanalytical activities and the broader development program. Assay development timelines cannot be considered independently from preclinical studies, clinical activities, sample availability, data deliverables, and regulatory milestones.

The bioanalytical capabilities available through Smithers Pharmaceutical Development Services include support for large molecule bioanalysis from discovery through later stages of development, including PK/TK, anti-drug antibody, neutralizing antibody, bioassay, molecular biology, and fit-for-purpose biomarker studies.

Biomarker Programs Require More Than Assay Performance

Biomarkers are another area where bioanalytical strategy extends beyond simply generating data.

Sponsors need to understand what a biomarker is intended to demonstrate, whether the assay is fit for its intended purpose, how the resulting data should be interpreted, and how those findings relate to safety, pharmacology, mechanism of action, efficacy, or regulatory questions.

Smithers Pharmaceutical Development Services provides biomarker assay development and validation for single and multiplex assays across complex matrices, including cerebrospinal fluid, synovial fluid, and aqueous and vitreous humor.

The analytical platform is only one component of the strategy. The purpose of the biomarker program and the decisions the data need to support should guide assay development.

A Bioanalytical Plan Should Reflect the Entire Development Program

Sponsors also face practical constraints that can affect whether a bioanalytical program stays aligned with the overall development timeline.

Laboratory capacity, assay development schedules, critical reagent availability, kit availability, sample timing, and reporting requirements all influence when data can be delivered. An assay that is technically appropriate but cannot be developed or implemented within the required timeline may not meet the needs of the program.

The relationship between bioanalysis and in vivo studies is also important. Preclinical and clinical activities generate samples that must move through the analytical workflow on schedules that support downstream decisions.

A successful bioanalytical program starts with an understanding of the sponsor's objectives, molecule, mechanism of action, timelines, and specific challenges. Those factors help shape an analytical plan around the needs of the development program rather than treating each assay as an isolated activity.

Bringing Difficult Bioanalytical Questions to AAPS PharmSci 360

AAPS PharmSci 360 brings pharmaceutical scientists together across research, development, manufacturing, analysis, and drug delivery. The 2026 program includes bioanalysis among its scientific areas, along with topics such as predictive modeling, artificial intelligence and machine learning, pharmaceutical manufacturing, and drug delivery.

For sponsors working with complex molecules, the conference provides an opportunity to discuss questions that may not have straightforward answers.

Those conversations can include the feasibility of novel assays, biomarker strategy, assay development and validation, critical reagent requirements, laboratory timelines, sample analysis, and the relationship between bioanalytical data and preclinical or clinical milestones.

Smithers Pharmaceutical Development Services' focus on large molecule bioanalysis includes support for biologics, monoclonal and bispecific antibodies, CAR-T, TCR, biosimilars, viral vectors, and other therapeutic technologies.

Meet Smithers Pharmaceutical Development Services at AAPS PharmSci 360

Sponsors do not need to have a fully defined bioanalytical question before starting the conversation. Discussions can address a novel assay that needs to be developed, a biomarker program that needs a fit-for-purpose strategy, a critical reagent constraint, an upcoming regulatory milestone, or a broader question about how bioanalysis should fit into the development timeline.

Visitors should also stop by booth 1205 to learn more about an exclusive event Smithers Pharmaceutical Development Services will be hosting during AAPS PharmSci 360 and how to participate.

The team brings extensive experience in large molecule bioanalysis and assay development to these discussions, with scientific support spanning method development, validation, and sample analysis.

Schedule a meeting with Smithers Pharmaceutical Development Services at AAPS PharmSci 360 to discuss a current bioanalytical challenge, explore requirements for a novel assay, or evaluate a strategy for an upcoming development milestone. Connect with Christina Satterwhite and Connie Scott at booth 1205 in New Orleans to discuss the bioanalytical requirements of the program.