Bioanalysis and Pharmacokinetic Expertise for Preclinical Success
Robust bioanalytical and pharmacokinetic/toxicokinetic (PK/TK) data are essential for safe, efficient drug development. From early discovery to GLP-compliant Investigational New Drug (IND)-enabling studies, successful preclinical programs rely on tailored strategies that reflect the specific behavior of each compound and modality, whether a small molecule, peptide, monoclonal antibody, fusion protein, or complex bioconjugate such as an antibody-drug conjugate (ADC).
We understand that every molecule and development plan require a tailored approach. That’s why our scientists work closely with your team to define the right bioanalytical strategy, aligned with your compound’s characteristics, study goals, and timelines.
With deep experience across therapeutic platforms and regulatory frameworks, our laboratories support fit-for-purpose and GLP studies with integrated method development, validated protocols, and regulator-aligned interpretation.
What is the result for you? Faster transitions, reduced risk, and confident candidate selection.
To understand how this is achieved in practice, let’s walk through the key analytical milestones that shape preclinical success.
Candidate Selection – Pilot PK/TK Studies
Pilot PK studies are often the first in-vivo step to assess a drug’s behavior in the body. These non-GLP exploratory studies are typically used to compare several candidate molecules in parallel, usually compounds of the same modality with different semisynthetic modifications or antibody clones targeting the same receptor.
Validated methods are not required at this stage, which allows for greater flexibility and faster execution. Our team supports these early programs with fit-for-purpose bioanalysis and rapid turnaround, enabling data-driven clinical candidate nomination.
Refining Dose and Safety – DRF & sophisticated PK/TK Studies
As candidate molecules (typically the lead and backup molecules) are selected, more sophisticated pharmacokinetic and toxicokinetic (PK/TK) studies are essential to guide final selection and inform safe, effective dosing strategies.
Dose Range Finding (DRF) studies, typically conducted under non-GLP or GLP-like conditions support the definition of appropriate dose levels, identify early toxicity signals, and provide the foundation for GLP toxicology. These studies often involve repeated dosing, expanded sampling, and detailed exposure profiling to assess accumulation, tolerability, and systemic exposure.
For both lead and backup compounds, tailored bioanalytical method development and comprehensive PK/TK analysis using software such as Phoenix WinNonlin ensure that critical exposure data is accurate, interpretable, and ready for integration into subsequent study phases.
Beyond PK measurements, immunogenicity assessments play a key role in biologics development. Anti-drug antibody (ADA) testing, commonly performed on the MSD platform, and neutralizing antibody (NAb) assays using cell-based formats, provide valuable insights into potential immune responses, supporting compound selection and patient safety.
Support Regulatory Framework – GLP Toxicology & pivotal PK/TK Studies
As development progresses toward clinical entry, regulatory authorities require robust, GLP-compliant PK/TK data to support Investigational New Drug (IND) or Clinical Trial Application (CTA) submissions. These pivotal studies generate the foundational exposure and safety data needed for clinical trial approval.
Our GLP-certified laboratories deliver fully validated bioanalytical methods alongside comprehensive non-compartmental and compartmental PK/TK analysis using Phoenix WinNonlin. Data are prepared to meet both FDA and EMA expectations, ensuring consistency, traceability, and acceptance across regions.
These data are critical for both IND submissions in the US and CTA submissions in the EU, supporting regulatory review and approval.
End-to-End Bioanalytical Support for Diverse Modalities
Our bioanalytical services are designed to accommodate the complexity and diversity of modern therapeutics. With extensive experience in method development and GLP validation, we support a broad range of matrices, including plasma, serum, and tissues as well as molecule types such as:
- Small molecule drugs
- Peptides and oligonucleotides
- Monoclonal antibodies
- Antibody-drug conjugates (ADCs)
- Other bioconjugates and complex biologics
A comprehensive suite of in-house technologies, including LC-MS/MS, ligand binding assays (ELISA, MSD), hybrid LBA-LC/MS approaches, and cell-based assays, enables the application of tailored analytical strategies for each molecule and study design.
This internal capability ensures that every approach aligns with the compound’s characteristics, regulatory requirements, and the specific objectives of your development program.
Explore a detailed testimonial showcasing our analytical and nonclinical bioanalytical support for HER-096, a small peptidomimetic advancing to Phase 1b trials for Parkinson’s disease. → Read more.
Conscio group is a scientific service provider committed to improving the safety and quality of pharmaceuticals, food and our environment. Beyond clinical and analytical expertise, the Group offers GMP manufacturing solutions for investigational medicinal products (IMPs), as well as formulation development and technology transfer across multiple dosage forms. Learn more at www.conscio.group
