Pre-Formulation / Formulation

Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies provides drug product development services with expertise on small and large molecules. We can rapidly develop a formulation that is best suited for your drug development program and also provide submission-ready documentation. If you are developing a new drug product or reformulating an existing drug, our team is composed of experts in oral liquid and solid dosage forms, parenteral formulations, ophthalmics, topical products buccal delivery, nasal/intranasal delivery and pulmonary delivery.

Our goal with each formulation development project is to quickly and cost-effectively identify a stable and pharmaceutically elegant dosage form that is optimal for the therapeutic indication and the intended route of administration. We focus on developing a formulation that is the best for the drug program itself and the Sponsor's development strategy. We have expertise in formulating new chemical entities or reformulating existing drugs, including biosimilars.

The selection of the dosage form is a key step in your drug development process. It will impact patient compliance, stability of your drug product and thus the success of your clinical study.

As an experienced CDMO, we support the development, manufacturing and packaging of an optimal oral dosage form, under Non-GMP or GMP conditions, with fully integrated analytical support and global project management.

Pre-formulation screening

During the pre-formulation phase, we determine the physical and chemical properties of the drug substance (or active pharmaceutical ingredient, API). This knowledge is used to select the most appropriate salt or polymorphic form and supports the design and development of the drug product, both for pre-clinical and clinical use. Furthermore, during pre-formulation studies, relevant analytical methods, such as stability indicating methods, can be developed and optimized to be used later on in the drug product development phase.

Our pre-formulation capabilities include:

• Drug substance chromatographic purity
• Spectroscopic characterization (IR, UV-vis, fluorescence, MS)
• Residual solvents, residual water, counter-ion content
• Dissociation constant (pKa)
• Particle size and morphology (laser diffraction, microscopic imaging)
• Density (bulk and tapped)
• Crystallinity (X-ray diffraction)
• Thermal analysis (melting point and glass transition)
• Solubility studies in organic and pharmaceutical solvents
• Excipient compatibility studies
• Material compatibility studies (contact parts, packaging materials)
• Forced degradation studies (heat, acid, alkali, light, peroxides, metal ions)

Formulation development

In the formulation development phase, we assess different drug product concepts in terms of stability, efficacy, processability, bioavailability and solubility enhancement. We rely on our extensive experience in a wide range of different drug delivery routes, drug delivery systems and drug production technologies, including:

• Oral liquid formulations (solutions, gels...)
• solid formulations (tablets, mini-tablets, bilayer tablets...)
• Parenteral formulations
• Ophthalmics
• Topicals (creams, gels...)
• Buccal delivery
• Nasal/intranasal delivery
• Pulmonary delivery

Bilayer tablets can improve the efficacy of active ingredients combination for the treatment of acute or chronic diseases.

Reformulation or formulation optimization

Eurofins CDMO network of companies has expertise formulating with new chemical entities or reverse engineering and reformulating existing drug products. We specialize in overcoming technical barriers associated with difficult-to-formulate drug substances, such as those that are poorly soluble or unstable.

Our experience supports reformulation or formulation optimization for Sponsors seeking to evaluate production alternatives or enhance patent protection, including:

• Lyophilized solution to stable liquid
• Liquid to semi-solid for topical application
• Excipient substitutions

GMP manufacturing

Eurofins CDMO network of companies has state-of-the art cleanroom facilities for GMP (Good Manufacturing Practice) compliant clinical supply manufacturing, packaging and labeling of liquid, semi-solid and solid dosage forms on lab and pilot scale. Clinical supplies or investigational medicinal products (IMPs) are quality controlled and released by a Qualified Person. Blinding and randomization of clinical materials can also be performed within our facilities.

GMP manufacturing capabilities include:

• Drug product types
• Solutions
• Microsuspensions
• Nanosuspensions
• S(M)EDDS
• Emulsions
• Semi-solids
• Amorphous Solid Dispersions
• Process types
• Spray drying
• Freeze-drying
• Wet granulation (fluid bed, high shear)
• Bead layering
• Tableting (bilayer tablets etc.)
• Capsules (encapsulation/over-encapsulation)

Following the production of the IMPs, most quality control (QC) analyses can be performed within our facilities to ensure project continuity and a smooth and safe transfer from R&D to GMP. Other and more specific test, such as microbial quality, can be performed within the Eurofins BPT network of companies.

Choose the Eurofins CDMO network of companies to help you:

• Formulate new chemical entities (NCEs) and generics
• Perform highly potent and cytotoxic development
• Improve the solubility and bioavailability of your drug
• Do a fast track from preclinical to FIH studies via the Highway-to-Clinic approach
• Manufacture clinical batches for early phase clinical studies up to small commercial batches, whether sterile or non-sterile
• Obtain a customized development strategy, including the ASAP approach
• Access to global project management and regulatory affairs support
• Manage the life cycle of your portfolio

Contact your CDMO expert >

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