Protein (Pre-)Formulation and Characterization for Biologics

Pre-formulation

Before pharmaceutical drug product formulation activities are started-up, pre-formulation studies are initiated. During the pre-formulation phase, the physical properties of the Drug Substance (DS) are determined and then compared under different formulation conditions. For biological Drug Substances, pre-formulation studies include either screening towards finding the most optimal conditions in support of downstream processing and/or ensure the best condition is selected in terms of CMC properties which will prove beneficial in further drug product development processes. Furthermore, during pre-formulation studies, relevant analytical methods can be optimized to be used later on in the drug product development phase.

Eurofins CDMO network of companies provides:

• Strong interaction with downstream processing team
• Buffer and pH screening
• Development of (frozen) liquid protein formulation (low vs high protein concentration)
• Stability and forced degradation studies
• Design of experiment (DoE) approach
• Drug substance characterization including melting point and aggregation point determination, purity, protein charge (pI), peptide mapping, particle size and activity (ELISA based)

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Formulation screening

In the formulation screening phase, formulation screening is performed in function of drug product development and administration route. Different type of buffers and excipients will be tested in order to stabilize the drug substance taking into account the needs for the applied delivery route. Information gathered during pre-formulation screening will speed up this process. The different drug delivery concepts are selected and compared to one another in terms of stability, efficacy and feasibility. Eurofins CDMO network of companies has experience with a wide range of different drug delivery routes, drug delivery systems and drug production technologies.

Drug delivery concepts can be worked out for the following delivery routes:

• Oral liquid/solid formulation
• Parenteral formulation
• Ophthalmic administration (topical or injection)
• Topical administration
• Pulmonary delivery
• Buccal delivery
• Nasal/intranasal delivery

Depending on the selected drug delivery route, the Drug Substance can be stabilized, bio-availability can be enhanced or the release-profile can be modified by multiple delivery concepts:

• Solutions
• Freeze-dried product (including lyo/cryo-protectant screening, lyophilization cycle optimization and scale-up development)
• Spray-dried powder (including protectant screening and process development)
• Tablet development (tablets, minitablets or coated tablets via spray drying, dry granulation and/or direct compression)
• Capsule development (dry blend, multiparticulates or granulates using spray dyring, dry granulation, and/or bead layering)
• Enteric coated tablets/capsules
• Emulsions

Choose Eurofins CDMO network of companies for your your (pre-)formulation and characterization studies on biologicals:

• We are experts in complex proteins development and characterization ensuring close monitoring of the protein throughout the entire process of formulation development to scale up.
• We have experience with a wide array of different drug delivery routes including oral delivery of biologicals
• We have a multitude of formulation innovative technologies to accommodate your desired drug delivery route
• Analytical method development is performed in-line with pre-formulation studies and will guarantee time-saving later on in the drug product development phase.
• We offer end-to-end services for biological drug development from Drug Substance to Drug Product including Clinical Trial Material delivery

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