Proteros Biostructures GmbH

Biologics Discovery Program Services

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"One-Stop-Shop" for Expression, Analytics-Driven Purification, Characterization, Developability Assessment. Have you run your biologics discovery program, passed the engineering phase and are now at a stage where you would like to further characterize your biologics? At Proteros we are familiar with a wide variety of biologics formats (bs-Ab, ms-Abs, cytokines, non-human antibody formats and antigens) and deliver the right biologics with accurate assembly, purity, structural and biophysical characterization and early developabilty assessment (non GxP) in a "one-stop-shop" approach to help you REACH RIGHT FASTER for your downstream applications.

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Proteros can express and purify your antigen and biologics at different research scales with low endotoxin levels and study the biologics-antigen biophysical/biochemical interaction, conduct structural analysis on epitope binding and stoichiometry, run antibody thermostability and stress tests and conduct early developability assessments for advanced molecules.

PROTEROS BIOLOGICS SERVICE OFFERINGS

EXPRESSION, PURIFICATION, ANALYTICS

  • Analytics-driven purification and quality control of your antigen and complex biologics at different research scales with low endotoxin levels

STRUCTURAL ANALYSIS

  • Fab-Antigen Crystallography
  • cryo-EM
  • LC-MS
  • Binding mode
  • Stoichiometry

BIOLOGICS-ANTIGEN INTERACTION ANALYSIS

  • Affinity
  • Kinetics
  • Residence time
  • Thermostability
  • Buffer stress tests

EARLY DEVELOPABILITY ASSESSMENTS (NON GXP)

  • Assessing manufacturability: expression and purification feasibility, stability, aggregation
  • Pre-formulation screening
  • Accelerated stress testing  (thermostability, freeze-thaw, buffer screening)

EXPRESSION

  • Transient and stable gene expression in mammalian cells (HEK, CHO - stable cell-pool/cell-line provided by customer)
  • Small-to-large scale (up to 50 L) "endotoxin-free" protein expression (non GxP; "plasmid-ready" supply by customer, average yields: >100mg/L (transient)

ANALYTICAL-DRIVEN PURIFICATION

  • Full suite of chromatographic purification techniques (a.o. 60 Äkta systems (Cytiva))
  • At least two-step purification / using Affinity Capture and SEC with high-quality bioprocess resins
  • Stable domain analysis
  • Typical batch size: 0.5 mg - 4g

QUALITY CONTROL

  • Cutting-edge analytical platform for "assembly-right" product delivery. Monomer content: >98% via SE-HPLC, Endotoxin-level: down to 0.1 EU/mg. Concentration: UV/Vis @280nm. Purity >98% via CE-SDS (LabChip)
  • CE-SDS (Caliper Labchip GX & GXII)
  • LC/MS (maXis plus)
  • HPLC, MALS and RI (Ultimate, Vanquish, Treos II, Optilab)

PHYSICOCHEMICAL CHARACTERIZATION

  • Purity/Impurity profile, charge heterogeneity, hydrophobicity
  • Post-translational modifications
  • Higher-order-structures, conjugate analysis, complex stoichiometry

BIOLOGICAL / FUNCTIONAL ANALYSIS

  • MoA-related biological assays: target binding (kd, kon, koff, avidity, selectivity)

STRUCTURAL DETERMINATION

  • LC-MS
  • Protein X-Ray Crystallography
  • cryo-EM

EARLY DEVELOPABILITY ASSESSMENT (NON GXP)

  • Assessing manufacturability: productivity and purification feasibility, stability, aggregation
  • Pre-formulation screening
  • Accelerated stress testing to determine early degradation behaviour (thermostability, freeze-thaw, buffer screening)