Formulation Development

At Just - Evotec Biologics, we offer platform approaches for antibody formulation development, as well as extended formulation screening for more complex molecules. Our primary goal is to provide you with a robust formulation that supports the long-term storage of both drug substance (DS) and drug product (DP).

Our antibody formulation platform service streamlines the development process for your antibody candidate. By leveraging prior knowledge and established processes, we can efficiently create a formulation without extending development timelines. This allows you to accelerate your journey to clinical trials.

Key Components of Our Antibody Formulation Platform:

1.  6-Month DP Verification Stability Study:
   1. Our comprehensive stability study monitors the physical and chemical stability of the antibody formulation stored at ICH temperatures to generate product stability knowledge early in the timeline.
   2. By monitoring the formulation over six months, we can confirm the temperatures suitable for long-term storage.
2. Surfactant Set Point Studies: We optimize the surfactant concentration by exposing the formulation to transportation stresses in the presence of variable levels of surfactant in addition to testing a secondary surfactant.
3. Freeze-Thaw Study: We perform freeze-thaw cycling on the antibody formulation to understand the impact of this stress, which is critical for both DS and DP development.
4. Viscosity: A full viscosity curve is measured to ensure suitability for end use applications such as subcutaneous/intramuscular injections.
5. In-Use Testing: We simulate the administration of your product through syringe hold or IV bag hold and infusion studies, evaluating the stability of your antibody through the process. We work with your clinical team to understand dose ranges for your product and to identify and source the correct components for the test.

At our biomanufacturing facilities in Redmond, WA and in Toulouse, France, we specialize in formulation screening studies to discover stabilizing formulations for complex target molecules. Our approach is tailored based on an understanding of your target product profile and a short development timeline. Here’s what we offer:

1. in silico Analysis
   With our molecular optimization services our scientists can unlock the potential of your antibody candidates and improve their developability with a comprehensive and proprietary multi-dimensional in silico analysis. This includes:
   1. Sequence based analysis to detect areas of possible liability (isomerization, deamidation, oxidation) and associated remediations.
   2. Utilization of ML/AI methods to detect stability violators and associated remediations.
   3. Modelling and structure-based assessment of molecular properties to rank your panels and aid in selecting the most appropriate formulations.
2. Multiple Formulation Candidate Identification
   Our team explores multiple formulation candidates to ensure the best fit for your molecule. Candidate formulations are tailor made for your molecule and are based on experience, early product knowledge, and the target product profile. We use FDA and/or GRAS approved excipients.
3. Biophysical Analysis
   We utilize high-throughput biophysical formulation screening to understand the conformational and colloidal stability of your molecule. In as little as a few days, we can rank order candidate formulations by each of these assays:
   1. PEG Solubility Assay: Determining the effects of formulation variables on solubility of your molecule in polyethylene glycol.
   2. Differential Scanning Fluorimetry/Calorimetry (DSF/DSC): Assessing thermal stability of each formulation as a function of temperature.
   3. Dynamic Light Scattering (DLS/kD): Comparing the diffusion interaction parameter between each formulation to improve both colloidal stability and viscosity.
   4. Static Light Scattering (SLS/tagg): Evaluating the effects of formulation variables on aggregation behaviour as the temperature is increased.
4. Accelerated Stability Studies
   We conduct accelerated stability studies on top candidate formulations at 25°C and 40°C to determine a final lead formulation, using stability indicating assays to guide the way.
5. Freeze-Thaw Studies
   We perform freeze-thaw cycling on the antibody formulation to understand the impact of this stress, which is critical for both DS and DP development.
6. Lead Formulation Identification
   We review all data meticulously to identify the lead formulation, setting the stage for early-phase formulation verification studies.

Our commitment is to deliver high-quality biopharmaceutical formulations that meet safety, efficacy, and stability requirements.