35+ years’ experience in mammalian bioassay and analytics development
~40% of DS and ~45% of DP programs involve complex biologics
10+ years in integrated drug substance / drug product analytics development

Benefit from integrated, end-to-end drug substance and drug product analytics expertise

Biologics drug substance analytical development usually focuses on understanding the molecule and how the manufacturing process impacts its quality. Analytical methods are closely linked to process development and are used to define and monitor critical quality attributes. Drug product analytical development focuses on the final formulated product, assisting process performance, stability and drug product delivery. Analytical methods must account for formulation components, container systems and long-term stability.

By aligning platform and product-specific methods across both drug substance and drug product domains, we create a single, coherent analytical development strategy for your biologic, no matter how complex.

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Platform versus bespoke analytical development strategies

Platform methods are applied to enable rapid development by leveraging validated, well-understood assays for common drug substance attributes such as purity, identity and basic potency. This reduces development timelines, increases robustness, and provides a strong baseline for comparability.

 

Analytical strategies must balance speed, consistency and adaptability.

We design biologics analytical development strategies that combine speed with scientific rigor and long-term scalability. By integrating platform methods with tailored development approaches, we help you generate reliable, phase-appropriate data across drug substance and drug product.

Platform methods provide a rapid starting point using validated, well-understood assays for attributes such as identity, purity, and potency. This approach supports consistency while reducing development timelines.

Bespoke analytical development builds on this foundation to address molecule-specific complexity. Using a Quality by Design (QbD) framework, we define critical quality attributes (CQAs), develop robust analytical target profiles (ATP), and apply structured method optimization (OFAT and DoE) to achieve fitness for purpose at each stage.

Together, these approaches create a single, coherent analytical development strategy that supports progression from early development to commercial manufacturing with confidence.

Mammalian drug substance analytical development and validation

Analytical development for drug substance evolves from rapid early‑phase methods to detailed characterization and validated assays for release and stability. 

We align analytical methods with process development to deliver reliable, decision‑ready data across the lifecycle. In early stages, high‑throughput methods assess key quality attributes such as aggregation, fragmentation, glycosylation and process‑related impurities to support fast optimization.

 

As programs advance, we provide deeper characterization, including: 

  • Primary structure analysis (sequence verification, LC‑MS)
  • Post‑translational modifications (glycosylation profiling, oxidation, disulfide mapping) 
  • Higher‑order structure (CD, DSC, fluorescence) 
  • Variant analysis using 2D‑LC‑MS and peak isolation  

Core analytical methods support a detailed understanding of product quality:

  • Purity: SEC, CE‑SDS, icIEF/IEX
  • Impurities: HCP (ELISA, LC‑MS/MS), residual DNA (qPCR)
  • Potency/activity: SPR, ELISA and cell‑based assays

In later stages, these methods are refined into validated assays supporting GMP release and stability testing, covering potency, purity, and impurity control in line with regulatory expectations.

Drug product analytical method development and validation

We develop and validate analytical methods to allow your drug product to meet quality, stability and regulatory expectations from clinical to commercial stages.

Our teams design phase-appropriate assays across purity, identity, content, and potency, supported by full method validation, GMP release, and stability testing.

Working closely with drug substance teams, we enable method transfer, co-validation, and cross-site comparability, delivering consistent, submission-ready data for your biologic.

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Advanced analytical solutions for your product integrity

We help identify and manage product and packaging risks that can affect stability, safety and supply.

Key capabilities that support reliable drug product performance throughout the lifecycle include: 

  • Particle characterization: spectroscopic and imaging analysis across visible, subvisible, and submicron ranges, supported by spectral libraries for rapid root-cause identification 
  • Extractables & leachables (E&L): mass spectrometry-based workflows to detect and characterize trace compounds from materials and single-use systems, including toxicological assessment 
  • Container closure integrity (CCI): helium leak testing, microbial ingress studies, and physical integrity methods to confirm packaging performance under real-world conditions 
INB-DPS-Forensics on demand
Stability studies

Stability studies show how the quality of a drug substance or drug product changes over time under different conditions, supporting shelf life and recommended storage. 

We provide:

  • 35+ years of experience in drug substance stability testing
  • 10+ years of integrated drug substance and drug product stability expertise
  • Ongoing post-approval studies to maintain product quality and compliance.

Our stability programs generate data to support regulatory submissions and long-term commercial manufacturing.

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Frequently Asked Questions

Our biologics analytical development services support a broad range of modalities, including monoclonal antibodies (mAbs), bispecific antibodies, scaffolds and recombinant proteins, antibody-drug conjugates (ADCs), vaccines, and viral- and cell-based therapies. We provide integrated drug substance and parenteral drug product analytics within a single network.

We define a phase-appropriate analytical development strategy from the outset. We apply validated platform methods for early-stage speed and combine them with custom analytical method development and validation as programs advance toward commercial manufacturing.

Our analytical development services for drug substance include methods for identity, purity, potency, and impurities. Techniques such as LC-MS, SEC, CE-SDS support detailed characterization and help define critical quality attributes (CQAs) for robust process development, comparability and regulatory readiness. 

Yes. Our drug product analytics capabilities support complex biologics, including ADCs, bispecifics and viral-based therapies (drug product). We deliver analytical method development, validation, GMP release and stability testing, supported by advanced analytics such as particle characterization, extractables and leachables and container closure integrity.

Yes. We provide integrated analytical development services across drug substance and drug product platforms, enabling method transfer,  co-validation, and consistent data packages. This supports a seamless path from development to commercial manufacturing. 

Our locations
Locations where these services are provided
Visp, Switzerland
Slough, United Kingdom
Basel, Switzerland
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