Biologics

"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.

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_icon_LINES

Expression, Purification, Analytics

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

Biologics_icon_LINES

Structural analysis

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

Biologics-antigen interaction analysis

  • Affinity
  • Kinetics
  • Residence time
  • Thermostability
  • Buffer stress tests
EARLY DEVELOPABILITY ASSESSMENTS_icon_LINES

Early developability assessments (non GxP)

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

Typical Biologics Formats

In the Biotech / Biologics Community

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Proteros Biologics Research Service Making a Difference

 

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)

Example Technologies Deployed

 

Expression and purification

 
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)

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

 

ANALYTICS

 

CE-SDS (Caliper Labchip GX & GXII touch HT)
  • Reproducible quantitation
  • Molecular weight sizing
  • Percent purity analysis of protein samples (HTP)

LC/MS (maXis plus)
  • Ultra-high-resolution TOF

HPLC, MALS and RI (Ultimate, Vanquish, Treos II, Optilab)
  • Broad range of HPLC based methods
  • Determination of absolute molar mass and size
  • Characterization of complexes and protein-conjugate analysis
  • Characterization 

 

CHARACTERIZATION

 

SPR (Biacore 8K /8K+)
  • Efficient screening for binders
  • Quantification of kd, Kon Koff values
  • Characterization, process optimization and quality control of small molecules and biotherapeutics

NanoDSF (Prometheus - Nanotemper)
  • Precise characterization of thermal unfloding, critical denaturant concentration, free folding energy

MST (Monolith NT115 - Nanotemper)
  • Efficient binding affinity and protein interactions

ITC
  • Isothermal titration calorimetry (Microcal ITC)
 
Protein X-Ray Crystallography
 
cryo-EM

 

Proteros Statistics

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biologics delivered per year

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biologics projects per year

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meaningful protein, protein-ligand and antigen-antibody structures per year