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Analytical Services for

Antibody-Drug Conjugates

Antibody-drug conjugates (ADCs) are transforming oncology with their potential for targeted, less toxic cancer treatments. However, their complex structure—combining biological and chemical components—poses significant challenges in analytical testing and regulatory compliance. Solvias addresses these challenges with comprehensive analytical capabilities, leveraging our deep expertise, experience, and state-of-the-art technology to keep your development on schedule and within budget.

Research
Preclinical
Early-Phase Clinical
Late-Phase Clinical
Commercial
Characterization (including method development)
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Comparability (including troubleshooting)
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Release Testing & Stability Studies​(including method validation and transfer)
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5

Expertise

10+ years of experience, 40+ recombinant mAb products, comprehensive analytical services, scientific & regulatory guidance.​

6

Precision

Our highly experienced team combines semi-automatic approaches with manual data verification to ensure accuracy.

7

Independence

Reliable solutions from initial characterization to manufacturer-independent product release testing to stability studies.

Characterization & Comparability

Deep expertise to assess the physical, chemical, and performance properties of your ADC, with tailormade packages to meet the specific needs of each molecule.

  • PepMap​
  • AAA (including extinction coefficient)​
  • N-terminal sequencing
  • CD (secondary structure)​
  • DSC (thermal stability)​
  • HDX
  • SEC​
  • RPC
  • Cell based Bioassay​
  • ELISA​
  • SPR
  • PepMap PTM​
  • Disulfide mapping​
  • Free Thiol​
  • Carbohydrate Structure (N-/O-Glycans)​
  • Conjugation confirmation (site specific)
  • IEX​
  • cIEF and cIEF-MS​
  • CZE
  • SEC or SEC-MALS (or AF4-MALS)​
  • Intact mass (incl. DAR ratio)​
  • CE-SDS​
  • AUC

Release Testing & Stability Studies

GMP routine testing with a set of quality- and stability indicating methods (phase appropriately) validated for this purpose and established compendial tests.

​Identity
  • Sequence: PepMap (UV/MS)​
  • Charge: cIEF, CZE, IEX​
  • Size: SEC, CE-SDS

Purity

  • Deamidation/Oxidation: qPepMap (UV/MS)​
  • Charge: cIEF, CZE, IEX​
  • Size: SEC, CE-SDS​
  • Toxin: Free Toxin RPC

Potency

  • Binding ELISA​
  • Cell-based Bioassay​
  • SPR

Process Impurities ​

  • rProt. A by ELISA​
  • rHCP by ELISA​
  • rHC-DNA by qPCR​
  • Heavy Metals​
  • Extractables & Leachables​

​Excipients​

  • Tween​
  • Antifoam​
  • Na+, Cl-
  • Bacterial Endotoxins​
  • Bioburden​
  • Sterility
  • HIC​
  • LC-MS
  • CCIT​
  • Appearance of Container
  • pH potentiometry​
  • Conductivity​
  • Degree of Coloration​
  • Turbidity​
  • Osmolality​
  • Sub-visible particles (LO, MFI)​
  • Visible Particles
Don't Take Our Word for it

Our Customers

“The scientific delivery of this quality work from the Solvias team exceeded industry standards. The team are masters of their craft.”
Doug Daniels
Sr. Director of QC, Veloxis Pharmaceuticals
“The drug delivery and physical characterization team provided outstanding support to fine tune analytical methods, perform product specific characterization studies and to complete in vitro BE studies required for product filing at the US FDA.”
Clarissa Gobetti, PhD
CSO, Phargentis
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