Whether you’re working in biologics formulation optimization, developability, or comparability assessments, count on Prometheus Panta to provide multi-parameter stability characterization and trustworthy results for your candidate molecules.

 

Collect data on thermal unfolding, particle sizing, and aggregation simultaneously throughout the entire thermal ramp for high-resolution, domain-specific stability characterization of biologics.

Prometheus Panta combines thermal unfolding, particle sizing, and aggregation for superior characterization of candidate molecules


Get high-resolution data that reveals liabilities in drug candidates missed by other technologies

Having the right technology when it really matters — to detect small differences or subtleties in unfolding events — makes a huge difference. Be confident you’re passing high-integrity results on to the next team which they can count on when making critical decisions.


Get domain-specific information about your candidate molecule when you measure thermal unfolding, particle sizing, and aggregation simultaneously throughout the entire thermal ramp

For the first time correlate particle sizing, thermal unfolding, and aggregation results collected throughout an entire thermal ramp — and get a completely new perspective about stability attributes at the domain level of your candidate molecule.


Get an instrument that has flexible throughput and a few choices for sample handling

Handle any project that comes your way no matter if you need to characterize just a few or a few dozen candidate molecules.

Evaluate critical parameters that help you progress confidently through your biologics discovery pipeline

Prometheus Panta for biologics

Prometheus Panta reports a thorough profile of your candidate molecule’s stability with a complete set of parameters for size analysis, thermal unfolding, and aggregation. To do this it uses DLS, nanoDSF, and backreflection technologies to give you a full picture of your candidate’s stability.

All the parameters that Prometheus Panta measures

 

Multi-parameter stability characterization is what Prometheus Panta is all about. In case you were wondering what those are, here’s the list.

 

Dynamic Light Scattering (DLS)

SIZE ANALYSIS


Tsize (from growth of rH in cumulants fit)
Temperature at which average particle size begins to increase


Tscattering (from scattering intensity)
Fragments, PROTACs, ions, nanoparticles, peptides, and carbohydrates


Average scattering intensity
Identifies if concentration is too high or low for proper size distribution analysis

 

CUMULANT OR SIZE DISTRIBUTION/REGULARIZATION ANALYSIS


rH
Hydrodynamic radius shows size of particle in solvated state


PDI
Polydispersity index represents distribution of size populations

 

SELF-INTERACTION ANALYSES


kD
Diffusion interaction identifies onset of unfolding and impact on colloidal stability


D0 determined from the kD analysis
Theoretical diffusion constant at concentration = 0

 

nanoDSF

THERMAL UNFOLDING


Tm (for 330 nm, 350 nm, and ratio)
Melting temperature, or point at which 50% is unfolded


Tonset (for ratio)
Temperature at which unfolding begins


Ea (*parameter derived from data)
Activation energy of unfolding


Reversibility of unfolding
Point at which irreversibility happens when unfolding

 

Backreflection

AGGREGATION


Tturbidity
Onset temperature of aggregation

The simultaneous detection of micro- and macro-aggregates with thermal unfolding of biologics with Prometheus Panta allows for very detailed characterization. Our drug discovery and development customers will benefit from this innovative instrument.

Thomas Schubert, CEO at 2bind, Germany

 

お客様の声

Monitor essential attributes throughout your biologics workflow

Your candidate molecules go through a long and complicated journey on their way to becoming a final product. Using the same instrument throughout this process ensures there’s consistency when you need to compare conformational and colloidal stability data across teams and sites.

Start multi-parameter characterization early on when candidate molecules are being considered, engineered, or modified, and then continue comparing throughout formulation, production, and validation with Prometheus Panta.

During developability, the goal is to identify the feasibility of molecules to progress successfully to development. Choose a technology that will uncover undesirable physical and chemical properties that impact solubility, stability, aggregation, etc.

 

Use Prometheus Panta to
Determine aggregation propensity
Get self and non-specific interactions
Characterize conformational (thermal) stability

Full antibody molecules, scFv, and Fab fragments can be engineered with higher thermodynamic stability and more efficient folding in mind. To determine which ones move forward to the next stage of drug development, choose a technology that has the resolution to uncover even the small differences in stability.

 

Use Prometheus Panta to
Determine aggregation propensity
Get self and non-specific interactions
Characterize conformational (thermal) stability

During isolation, purification, and scale-up, candidates are monitored to make sure these processes won’t negatively impact their stability. This calls for a technology that precisely measures a variety of stability attributes.

Use Prometheus Panta to
Characterize conformational (thermal) stability and determine aggregation propensity and size distribution during scale-up and optimization of processes

In pre-formulation, the physical and chemical properties of the candidate molecules are established. During formulation, the finalized formula that will be used in clinical trials is defined, including buffer and excipient screening and compatibility. For both processes you evaluate stability attributes to help you choose the best formula.

Use Prometheus Panta to
Characterize conformational (thermal) stability
Determine aggregation propensity
Perform buffer and excipient screening and compatibility with melting scans with particle sizing, size distribution, and aggregation propensity

Stability studies at the IND stage provide impurity profiles for investigational products used during non-clinical toxicological studies. At the NDA stage, stability is monitored to establish appropriate retest or expiration guidelines, long-term storage conditions, and provide evidence of the effect of various environmental conditions.

Use Prometheus Panta to
Determine thermal stability and particle sizing on reconstitution/ dilution/admixing at initial and final time points
Get thermal stability and particle sizing from forced degradation and photostability studies

Comparability studies take place when changes in the manufacturing process are introduced, to make sure they won’t negatively impact the quality, safety and efficacy of the drug. For this analysis, stability is tested pre- and post-change.

Use Prometheus Panta to
Characterize conformational (thermal) stability including accelerated stress conditions spanning a broad concentration range
Determine particle size distribution

Be confident you’re choosing the right candidates with precise, high-resolution data

Missing subtle details means you may find yourself unintentionally handing over subpar candidates to teams working downstream — a costly mistake for drug pipelines. Prometheus Panta supplies high quality data to ensure you consistently deliver reliable results.

Anytime you’re comparing thermal unfolding for multiple molecules, you need precise measurements to resolve minute differences. Prometheus Panta, captures precise Tm values within ± 0.1 °C while other instruments only offer values within ± 1.5 °C. And when you need to identify subtle unfolding events, Prometheus Panta has an unmatched resolution of ± 0.008 for F350/F330 ratios.

Become more efficient with simultaneous measurements. Share clear and actionable results sooner.

Identify and differentiate stability behavior

Simultaneous acquisition of nanoDSF, DLS and backreflection measurements collected throughout the entire thermal ramp for Herceptin in three different buffer conditions.

Providing clear and actionable results quickly gets more complicated when you need to measure multiple parameters. And, when you’re up against deadlines and your colleagues are relying on you for reliable results, it’s difficult not to feel under pressure. With Prometheus Panta, become more efficient by measuring multiple parameters simultaneously — Tm, Tturbidity, and rH — throughout a single thermal ramp. And, provide your colleagues with clear and actionable stability results sooner.

Prometheus Panta takes care of your changing throughput demands

Large projects…small projects…and everything in between will inevitably come your way. Having an instrument that allows for flexible throughput will not only help you tackle any size project, but more importantly you feel prepared and able to complete projects efficiently.

Prometheus Panta takes care of your changing throughput needs — choose single capillaries for those smaller projects or capillary chips to make loading samples more convenient and faster for the larger ones.

Want to learn more about Prometheus Panta?

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