FDA-plate

The ready-to-use tool for pre-formulation and buffer-optimization of antibodies and other proteins.

 

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Applications

The 2bind FDA-plate® provides 96 pre-made buffer conditions from approved Formulations of Developed Antibodies.

All buffers were designed by antibody formulation experts and have already proven to be beneficial for stability and storage of therapeutic antibodies. Each buffer has been approved by FDA or EMA for use in antibody formulations.

Use the FDA-plate® for analysis of protein and antibody stability, buffer optimization, and (pre-) formulation development. Or use the plate to determine important parameters for regulatory approval of your antibodies like colloidal stability, thermal stability, freeze-thaw resistance, chemical stability, or long-term and forced degradation behavior.

Stability optimization

Identify optimal conditions for antibody and protein stability. Thermal and chemical stability, long-term storage, forced-degradation, and (pre-)formulation.

Screening tool

Apply the FDA-plate buffers quickly and easily to your methods of choice (e.g. DSF, nanoDSF, DSC, DLS, LC-MS, SEC-HPLC, ELISA).

Pre-formulation development

The FDA-plate buffers are optimal starting points for pre-formulation development and buffer optimization of antibodies and other proteins.

Features

• 96 buffer conditions from FDA- and EMA-approved formulations of therapeutic antibodies

• Ready-to-use 5x stock solutions (0.2 mL)

• Wide range of different buffer compositions:

pH: 6.0 – 8.0 (acetate, citrate, glycine, histidine, phosphate)

Salts: 3 – 200 mM (potassium chloride, sodium chloride)

Amino acids: 1 – 300 mM (glycine, glutamate, methionine, proline)

Sugars: 12 – 300 mM (maltose, mannitol, sorbitol, sucrose, trehalose)

Detergents: 0 – 1.6% (polysorbate 20, polysorbate 80)

Your Advantages

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Save time

No need to prepare buffers. Just dilute your sample of choice into the pre-made buffers and you are ready to go.

Save costs

No need to buy small quantities of expensive buffer substances. Cut analysis costs by saving hands-on-time in the lab.

Ensure quality

All buffers are made to highest quality standards and are tested with reference antibodies. Each buffer is also available as a re-fill stock.

How it works

Featured Case Studies

Explore the power of the FDA-plate for antibody pre-formulation development and many more applications below.

More application examples to follow soon!

For a list of all application notes visit our AppNote database.

For an overview of all services we offer, check the services for antibodies or the services for protein analysis.

Using the FDA-plate for testing freeze-thaw stability of an HIV immunogen

Stay tuned …

FDA-plate and nanoDSF - the perfect team for protein pre-formulation and stability analysis

Look here if you want to read more on how the FDA-plate can be used for optimizing antibody and protein stability and quickly develop pre-formulation conditions.

Testing buffer dependence of antibody-antigen binding kinetics with the FDA plate

Stay tuned …

Options

Let us do the work for you

2bind is one of the world’s leading service providers for biophysical analyses in drug discovery, antibody development, aptamer research, and protein biophysics.

From over 8 years of experience in these fields, we know what really matters: Quality, speed, affordable costs.

Therefore, we also offer to analyze your samples of choice for you in a high-throughput nanoDSF setup:

 

  • Minimal sample consumption (100-300 µg antibody for full FDA-plate analysis).

  • Investigation of antibody stability, unfolding, refolding, and aggregation.

  • Including detailed data analysis and reports.

  • All that for very affordable costs and with quick timelines.

Request your FDA-plate or 2bind Service

Fill out the form to the right and we will provide you with a quotation shortly, typically within only a few hours.

Just select your FDA-plate option or whether you prefer a 2bind-antibody or protein analysis service using the FDA-plate and a state-of-the-art nanoDSF method.

Contact Specialist