Optimising formulation through simultaneous measurements

What would you do with more time? Continue to optimise your formulation? Revisit that protein previously deemed an “undruggable target”? Take a course in AI? Thinking about getting back a few hours each week to explore something new or to simply stay on top of your current workload is pretty exciting. At Wyatt Technology^TM, a portfolio of Waters^TM, we have several solutions to give you back your day while still delivering advanced characterisation.

Challenges in formulation and upstream process development

Small changes in structure introduced through aging, stress, or during bioprocess can lead to loss of activity, potency, and aggregation, rendering a top therapeutic candidate ineffective. During formulation of a biologic therapy, excipients such as amino acids, salts, sugars, and surfactants are added to the pH-stabilising buffer to optimise stability and solubility. Additional adjuvants and preservatives are also added to increase efficacy and maintain the shelf life. This formulation complexity requires significant testing and relies on techniques such as dynamic light scattering (DLS).

Increase productivity during formulation

The Wyatt DynaPro^® Plate Reader has a capacity for 384 samples and the ability to run advanced biophysical analyses unattended, giving you, your day back without compromising productivity.

It provides key chemical and conformational attributes such as:

• size (hydrodynamic radius, RH)
• particle concentration
• stability indicators (T_m, T_agg, k_D diffusion interaction, A₂, 2nd virial coefficient/colloidal stability)

While the Plate Reader measures the impact of post translational modifications (PTM) on higher order structure and how kosmotropic agents like trehalose can change stability, you can give yourself and your team back time.

Shorten Time to Market

Maybe your issue with time is that you need to deliver your results faster. Think about the acceleration that was needed and delivered for lipid nanoparticle (LNP)-based vaccines. Leading edge LNPs have a narrow window for optimum efficacy and safety. They must be sufficiently small for safe injection and to escape the immune system, but sufficiently large to encapsulate the therapy. On top of that, their charge density needs to be high enough to avoid aggregation, but low enough to deliver their cargo.

Address questions earlier in your workflow

With these constraints, optimisation, and formulation of LNPs and other nanoparticles is time-consuming. This is where Wyatt Technology, offers a solution with the newly launched, DynaPro^TM ZetaStar^TM instrument. It has the ability to measure dynamic, static, and electrophoretic light scattering (DLS/SLS/ELS) all in one platform providing measurements of: 

• size and size distribution
• zeta potential (charge)
• turbidity
• particle concentration
• stability indicators (T_m, T_agg, k_D, A₂)

And for even greater throughput, the ZetaStar instrument can be paired with the Arc™ HPLC autosampler.

The molecules being developed are only becoming more complicated requiring more tests and instrumentation to interrogate them. Light scattering instruments like the Wyatt Plate Reader and ZetaStar DLS provide multiple quality attributes simultaneously and incorporate hands-off automation to give you back time.